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What are the four types of risk analysis?

You are familiar with design and process risk analysis, but do you know all four types of risk analysis?

Last week’s YouTube live streaming video answered the question, “What are the four different types of risk analysis?” Everyone in the medical device industry is familiar with ISO 14971:2019 as the standard for medical device risk management, but most of us are only familiar with two or three ways to analyze risks. Most people immediately think that this is going to be a tutorial about four different tools for risk management (e.g. FMEA, Fault Tree Analysis, HAZOP, HACCP, etc.). Instead, this article is describing the four different quality system processes that need risk analysis.

What are the four different types?

The one most people are familiar with is risk analysis associated with the design of a medical device. Do you know what the other three are? The second type is process risk management where you document your risk estimation in a process risk analysis. The third type is part of the medical device software development process, specifically a software hazard analysis. Finally, the fourth type is a Use-Related Risk Analysis (URRA) which is part of your usability engineering and human factors testing. Each type of risk analysis requires different information and there are reasons why you should not combine these into one risk management document or template.

Design Risk Analysis

Design risk analysis is the first type of risk analysis we are reviewing in this article. The most common types of design risk analysis are the design failure modes and effects analysis (dFMEA) and the fault-tree analysis (FTA). The dFMEA is referred to as a bottom-up method because you being by identifying all of the possible failure modes for each component of the medical device and you work your way backward to the resulting effects of each failure mode. In contrast, the FTA is a top-down approach, because you begin with the resulting failure and work your way down to each of the potential causes of the failure. The dFMEA is typically preferred by engineers on a development team because they designed each of the components. However, during a complaint investigation, the FTA is preferred, because you will be informed of the alleged failure of the device by the complainant, but you need to investigate the complaint to determine the cause of the failure. Regardless of which risk analysis tool is used for estimating design risks, the risk management process requires that production and post-production risks be monitored. Therefore, the dFMEA or the FTA will need to be reviewed and updated as post-market data is gathered. If a change to the risk analysis is required, it may also be necessary to update the instructions for use to include new warnings or precautions to prevent use errors.

Process Risk Analysis

Process risk analysis is the second type of risk analysis. The purpose of process risk analysis is to minimize the risk of devices being manufactured incorrectly. The most common method of analyzing risks is to use a process failure modes and effects analysis (i.e. pFMEA). This method is referred to as a bottom-up method because you begin by identifying all of the possible failure modes for each manufacturing process step. Next, the effects of the process failure are identified. After you identify the effects of failure for each process step, the severity of harm is estimated. Then the probability of occurrence of harm is estimated, and the ability to detect the failure is estimated. Each of the three estimates (i.e. Severity, Occurrence, and Detectability) are multiplied to calculate a risk priority number (RPN). The resulting RPN is used to prioritize the development of risk controls for each process step.

As risk controls are implemented, the occurrence and detectability scores estimated again. This is usually where people end the pFMEA process, but to complete one cycle of the pFMEA the risk management team should document the verification of the effectiveness of the risk controls implemented. For example, if the step of the process is sterilization then documentation of effectiveness consists of a sterilization validation report. This is the last step of one cycle in the pFMEA, but the risk management process includes monitoring production and post-production risks. Therefore, as new process failures occur the pFMEA is reviewed to determine if any adjustments are needed in the estimates for severity, occurrence, or detectability. If any of the risks increase, then additional risk controls may be necessary. This process is continuously updated with production and post-production information to ensure that process risks remain acceptable.

Software Hazard Analysis

Sofware hazard analysis is becoming more important to medical devices as physical devices are integrated with hospital information systems and with the development of software as a medical device (SaMD). Software risk analysis is typically referred to as hazard analysis because it is unnecessary to estimate the probability of occurrence of harm. Instead, it is only necessary to identify hazards and estimate harm. Examples of these hazards include loss of communication, mix-up of data, loss of data, etc. For guidance on software hazard identification, IEC/TR 80002-1:2009 is a resource. FDA software validation guidance indicates that software failures are systemic in nature and the probability of occurrence cannot be determined using traditional statistical methods. Therefore, the FDA recommends that you assume that the failure will occur and estimate software risks based on the severity of the hazard resulting from the failure. 

Use-Related Risk Analysis

The fourth and final type of risk analysis is use-related risk analysis (URRA). Most development teams assume that they are able to use traditional hazard identification techniques to identify the potential use-related risks. However, use-related risks are inextricably linked to the experiences of the user. The development team has unique knowledge of the device they are developing, and therefore it is likely that use-related risks associated with a lack of knowledge about the device will result in use errors that the development team would not realize. For this reason, formative testing is necessary to identify unforeseen use-related risks. Once formative testing identifies these risks, additional formative usability testing can be used to create and refine the instructions for the use of a medical device. Finally, formative testing can be used to develop user training programs that prevent potential use errors. Once the development team has completed the necessary formative testing, then summative usability testing is used to validate the effectiveness of the risk controls that were implemented.
 
In the past, I believed that the FDA’s focus on usability was the review of summative usability testing. However, I have learned that the FDA feels it is equally important to begin the human factors testing process by first performing a use-related risk analysis and then identifying the critical tasks. Without identifying these critical tasks, it is not possible for the FDA to determine if the moderator of the summative testing has observed all of the critical tasks being performed correctly. An example of a Use-Related Risk Analysis (URRA) was provided by the FDA in a 510(k) AI deficiency letter that we received. The example is provided below.
URRA table example from the FDA 300x117 What are the four types of risk analysis? Example of a URRA Table provided by the FDA
 

Can you use only the IFU to prevent use-related risks?

Instructions for use (IFU) are required to include warnings and precautions. This information provided by the manufacturer explains how to use a medical device correctly and identifies the residual risks. This is a form of risk control, but it is the least effective form of risk control and should be the risk control of last resort. Not everyone reads the IFU, and you cannot guarantee that everyone will understand the instructions. You certainly can’t be sure that users will remember all your warnings or precautions when they are tired, stressed, or acting in an emergency situation. Design controls and protective measures should be implemented as the first and second priority for risk controls, and the IFU should be your lowest priority.
 
This is the reason why we have color-coding, design features that eliminate the possibility of a use error, we provide training to users, and we are required to monitor use-related risks for medical devices. Formative usability testing is intended to identify use errors we did not anticipate, to help us develop instructions for use (IFU), and help us develop training for users. Summative testing is intended to validate that the design, training, and IFU are effective at preventing use errors. All three of these aspects work together–not the IFU alone. In fact, there is an entire alarms standard that identifies protective measures that shall be used for electromedical devices to prevent use errors (i.e. – IEC 60601-1-8).

 

Facilitating Risk Management Activities – An Interview with Rick Stockton

I listened to our YouTube video about the four different types of risk analysis, you may have heard my reference to Rick Stockton’s interview that we posted on our YouTube channel and embedded above. In our interview with Rick Stockton, we discussed how to facilitate risk management activities during the design and development of medical devices. If you are interested in learning more about Rick and facilitating risk management activities, please watch the video of our interview with Rick.
 

Posted in: ISO 14971:2019 (Risk Management)

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Medical Device Shortage Reporting

The FDA and Health Canada both have executive-level orders requiring medical device shortage reporting or supply-chain disruptions.

In a previous article, we discussed supply-chain disruptions and mentioned that there might be medical device shortage reporting requirements if that disruption causes a market shortage of the manufactured device. Both the United States and Canada have reporting requirements for supply disruptions or the market’s ability to meet the demand of specific types of devices.

Both the U.S. FDA and Health Canada have executive-level orders that require reporting of shortages or disruptions to the supply of medical devices deemed necessary for the COVID-19 Health Emergency. There is some overlap, but each country is monitoring and experiencing shortages and disruptions of different devices.

Where did medical device shortage reporting responsibilities come from?

Check 21 CFR 820, ISO 13485:2016, and even peek at SOR 98-282 and see if you can find your obligations for reporting. Go ahead. I’ll wait… Not much in there, right? Adverse events, complaints, etc., but not market shortages.
Medical device shortage reporting is specific to health emergencies. The U.S. FDA and Health Canada happen to be two authorities having jurisdiction with reporting requirements for shortages concerning the COVID-19 Health Emergency. However, there may be others, so having your organization’s regulatory affairs manager verify the reporting requirements for the markets in which you are engaged might not be bad.

U.S. FDA 506J reporting-

fda logo Medical Device Shortage Reporting
U.S. FDA logo

In the United States, an Amendment to the U.S. Food, Drug, and Cosmetics Act requires regulatory reporting by medical device manufacturers to the U.S. FDA. It is sometimes called 506J reporting for the Section of the U.S. FD&C Act where it is located.

You will find the statutory requirements outlined within 21 USC 356J.

21 USC 356j screenshot from uscode.house .gov cropped title Medical Device Shortage Reporting
21 USC 356J Discontinuance or interruption in the production of medical devices

For the full text read, 21 USC 356j: Discontinuance or interruption in the production of medical devices. (Interestingly enough, the website where this information is available is not an HTTPS site, so visit at your own discretion).

http://uscode.house.gov/browse.xhtml

What devices are subject to 506J reporting?

There are two types of devices that the FDA is monitoring. “Critical” devices and an FDA-published list of devices for which COVID-19 is causing a higher than expected demand.

The FDA has released a guidance document that contains criteria for what is considered to be a “Critical Device”. This includes devices such as those used during surgery, emergency medical care, and those intended to treat, diagnose, prevent, or mitigate COVID-19.

fda guidance criteria for 506j critical devices Medical Device Shortage Reporting
Screenshot of the Critical Device Criteria for 506J reporting

There is also a published list of concerned devices that the FDA is specifically monitoring. The FDA website lists these devices by product code, but include the following device types;

  • Clinical Chemistry Products
  • Dialysis-Related Products
  • General ICU/Hospital Products
  • Hematology Products
  • Infusion Pumps and Related Accessories
  • Microbiology Products
  • Needles and Syringes
  • Personal Protective Equipment (PPE)
  • Sterilization Products
  • Testing Supplies and Equipment
  • Ventilation-Related Products
  • Vital Sign Monitoring
fda 506j shortage list screenshot Medical Device Shortage Reporting
Screenshot of the FDA Shortage List

Understandably this process may not be intuitive, and for this, the FDA has released a guidance document that addresses;

  • Who must make the notification
  • When you should make a notification
  • What information needs to be included within your 506J notification
  • How to make a notification, and
  • Penalties for failure to make a notification

The referenced product codes may not be an all-inclusive list or entirely up to date. The best suggestion for full compliance is to go straight to the source of the regulation, in part because noncompliance can result in enforcement action from the FDA. If you think that your device might require notification to the FDA but isn’t in the reference table, you should contact the FDA for notification clarification. Below is the quote from the FDA website, and it includes the contact email for asking these specific questions to ‘the agency.’

“If a device type is not included in this table, but you believe it requires a notification under section 506J of the FD&C Act, or if you have questions regarding the device types in this table, you should contact FDA at CDRHManufacturerShortage@fda.hhs.gov and include “Question” in the subject line of the email.”

Link to the FDA Guidance Document for 506J Reporting- HERE

How to make a 506J report to the U.S. FDA?

The FDA accepts 506J reports in multiple ways. For example, you may use the 506J Reporting web form or submit a notification by email directly to (Include Email Here). In addition, Medical Device Academy has developed a Work Instruction and Form to determine if your company is experiencing a reportable discontinuance or meaningful disruption in manufacturing a medical device as well as compiling the report for submission.

There are a few methods of notification, a web form for individual notifications and spreadsheet options for multiple notifications at once, or emailing a report directly to the FDA reporting email included below;

CDRHManufacturerShortage@fda.hhs.gov

fda 506j webform screenshot Medical Device Shortage Reporting
Screenshot of the FDA 506J reporting Webforms from https://fdaprod.force.com/shortages

It is for this process that Medical Device Academy developed WI-010 506J Shortage Reporting to the U.S. FDA. This work instruction and associated form, FRM-053 506J Reporting Form are designed to walk you through the process of determining reportability and compiling the information necessary to either complete the webform or email the report directly to the shortage reporting email.

Medical Device Shortage Reporting to Health Canada

health canada logo sante canada 1024x224 1 Medical Device Shortage Reporting
Health Canada logo

Rather than discontinuance and disruption of manufacture, Health Canada is monitoring for shortages of specific devices. Therefore, Health Canada wants Medical Device Shortage Reports regardless of the reason for the shortage. It also shows that this is not identical reporting of the same conditions to two different authorities. Health Canada will also accept reports from Importers because the frame of reference is Canada’s supply of medical devices concerning Canada’s needs.

As an Authority Having Jurisdiction, Health Canada also has reporting requirements for medical device shortage reporting of specific types of medical devices. Health Canada is also an independent authority that uses a different device classification system than the U.S. FDA.

The table below shows the device types by their classification level that HC requires supply chain disruption notifications for. This information is current as of September 5th, 2021, and the link below will take you to the HC website page for the most up-to-date list.

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/covid19-mandatory-reporting.html

Class I Medical Devices
Masks (surgical, procedure or medical masks) – Level 1, 2, 3 (ATSM)
N95 respirators for medical use
KN95 respirators for medical use
Face shields
Gowns (isolation or surgical gowns) – Level 2, 3 and 4
Gowns (chemotherapy gowns)
Class II Medical Devices
Ventilators (including bi-level positive airway pressure or BiPAP machines, and continuous positive airway pressure or CPAP machines)
Infrared thermometers
Digital thermometers
Oxygen Concentrators
Pulse Oximeters (single measurement)
Aspirators/suction pumps (portable and stationary)
Laryngoscopes
Endotracheal tubes
Manual resuscitation bags (individually or part of a kit)
Medical Gloves – Examination and Surgical (Nitrile, Vinyl)
Oxygen Delivery Devices
Class III Medical Devices
Ventilators (including bi-level positive airway pressure or BiPAP machines)
Pulse Oximeters (continuous monitoring)
Vital Signs Monitors
Dialyzers
Infusion Pumps
Anesthesia Delivery Devices
Class IV Medical Devices
Extracorporeal Membrane Oxygenation (ECMO) Devices
List of ‘Specified Devices’ that Health Canada is monitoring for shortage reporting

One of the things that Health Canada does an excellent job of is defining its expectations. In the Second Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19, it is explained the Manufacturers or Importers should report to the Minister actual or expected shortages of the device, OR components, accessories, or parts. These notifications must be made within 5-days of becoming aware of the shortage or the anticipated shortage date. Update reports must be made within 2-days of becoming aware of new information regarding the shortage, and a closing report must be made within 2-days of the end of the shortage.

(This link is to the HC website for the 2nd Interim Order referenced above)

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drug-medical-device-food-shortages/interim-order-2021.html

How to make a shortage report to Health Canada?

These reports are submitted online through the Health Canada Website. They have an entire section dedicated to medical device shortages, and the reporting links can be found there (Link here). If you have any questions or are on the fence about notification, you can email Health Canada at MD.shortages-penurie.de.IM@canada.ca.

Inkedhc reporting shortages overview screenshot edited LI 1024x384 Medical Device Shortage Reporting
Health Canada Webforms for reporting a shortage and the end of a shortage

The webform for reporting a shortage is the same webform that is used for providing update reports to Health Canada as well. This is both for manufacturers of specified medical devices as well as importers.

Posted in: FDA, Health Canada

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Where to Focus Your Medical Device Complaint Handling Training

%name Where to Focus Your Medical Device Complaint Handling Training

Medical Device Academy performed data analysis of FDA 483s for 2013 and identified four areas of focus for your medical device complaint handling training. 

One of the challenges of creating a strong training curriculum is the need for practical examples. This is why there are lots of stories about real-life companies and products in every Medical Device Academy training event. We learn more from our painful mistakes than we do from our success stories. When you recall a product, report deaths involving a product your company made, or if you receive a Warning Letter—these are events that we will never forget.

Medical Device Academy recently posted a blog (http://bit.ly/outsourcing-complaints) about complaint handling, because this is one of the most common areas identified in FDA Form 483s and Warning Letters. Therefore, if you are trying to develop training on the topic of complaint handling (i.e., 21 CFR 820.198), then you should look for examples from your competitor’s mistakes. The following is a list of places you should look:

  1. Past inspection reports issued to your company by the FDA
  2. Any inspection reports or Warning Letters about your competitors that become public
  3. Other Warning Letters that mention complaint handling as an issue

Here’s an example of the type of 483 observation you might find: “Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).”

The example above identifies five different problems with a complaint process:

  1. You need a procedure 
  2. You need to designate a complaint handling unit
  3. You need to define the process for receiving complaints
  4. You need to define the process for reviewing complaints
  5. You need to define the process for evaluating complaints

21 CFR 820.198 is a prescriptive requirement in the regulations. Therefore, you not only need to create a procedure specifically for complaint handling, but you also need to ensure each element of the requirement is satisfied. This is important because FDA inspectors will verify that your procedure includes each element.

Medical Device Academy performed data analysis of FDA inspection reports for FY2013 (http://bit.ly/Form483-FY2013) to identify other common mistakes related to complaint handling. The data analysis of FDA inspection reports for FY2013 identified that there are 15 individual citations related to complaint handling that the FDA identified using the TURBO EIR System (http://bit.ly/FDA483s). The table below summarizes the frequencies of these 15 sub-sections that were referenced in citations during FY2013 under the complaint handling category: 

483 Where to Focus Your Medical Device Complaint Handling Training

Medical Device Complaint Handling Training: 4 Critical Areas of Focus

The above table identifies several other sub-sections that present problems for companies. Based on the data analysis, your company should also be training your complaint handling unit in the following four critical areas:

  1. Maintaining complaint files
  2. Reviewing and evaluating complaints for the need to perform an investigation
  3. Documenting complaint investigations in your complaint files
  4. Determining whether a complaint is reportable under 21 CFR 803

The fourth area is one of the most important because these complaints involve injury, death, and product malfunction. Therefore, you might consider reviewing the TPLC database (http://bit.ly/FDATPLC) for MDRs. The best data to review is data for the same product codes that your company distributes, but reviewing any MDRs can teach your employees which types of incidents need to be reported. This area will also receive increased scrutiny with the recent changes to 21 CFR Part 803 (http://bit.ly/udpated-21CFR803).

Posted in: Complaint Handling

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A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure

new 803 A Gap Analysis Tool for Updating Your Medical Device Reporting ProcedureThis blog shows you where to find the new FDA regulation for medical device reporting (http://bit.ly/udpated-21CFR803) and the associated guidance document (http://bit.ly/Part803-Guidance). There is also an explanation of how to perform a gap analysis to compare your procedure for medical device reporting against the new 21 CFR 803 (http://bit.ly/Old-21CFR803).

On January 22, 2014, Medical Device Academy posted a blog about how to create your own FDA medical device regulatory updates: http://bit.ly/4Ways-to-Follow-CDRH. That post identified a number of sources on the FDA website where you can locate information about new and revised FDA regulatory requirements. One suggestion was to register for receiving the RSS feeds from the following page: http://bit.ly/CDRH-news-updates. This page is where the FDA’s Center for Devices and Radiological Health (CDRH – http://bit.ly/FDA-CDRH) posts news and updates.

If you registered for the RSS feed from CDRH, then you received an update on February 13, 2014, announcing the new Part 803 regulation for medical device reporting. This is NOT a cause for alarm. The fundamental change is simple:

Medical device manufacturers will no longer be allowed to submit FDA Form 3500A in paper form. It will need to be submitted electronically through the Electronic Submissions Gateway (ESG) (http://bit.ly/ESG-FDA).

ESG Sign-up

This is just another small step for the FDA to move toward digital records, and to integrate with electronic medical records from healthcare providers. The FDA even created a presentation explaining the process for electronic Medical Device Reporting (eMDR). This 8 minute and 45-second presentation are available on the CDRH Learning page: http://bit.ly/CDRH-Learn. Slide 5 of the FDA’s presentation identifies the six steps for obtaining an account for an ESG:

  1. Get a test account with the ESG
  2. Send a letter to authenticate your digital identity (http://bit.ly/Non-repudiation-Letter)
  3. Get a digital certificate
  4. Contact CDRH (eMDR@fda.hhs.gov)
  5. Test sending an MDR to CDRH
  6. CDRH approves production account with the ESG

I have been recommending that my clients switch from submission of the paper FDA Form 3500A to eMDR since 2010 when this training became available. Now, you have 18 months to switch over to eMDR before the August 14, 2015 deadline for implementation. Alternatively, you can also outsource your eMDR reporting to a  service provider that already has an ESG (http://bit.ly/outsourcing-complaints).

Comparison of Current & New Regulations

The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (http://bit.ly/udpated-21CFR803), and copied and pasted each section into a Word document. We also did this for the current version (http://bit.ly/Old-21CFR803). Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents. If you would like to download this gap analysis, please visit the following webpage: http://bit.ly/21_cfr_803_gapanalysis.

Gap Analysis of Your Medical Device Reporting Procedure

After you download the gap analysis tool that Medical Device Academy created, then you need to perform your gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meets the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).

Next Steps

  1. Download the gap analysis of the new and old versions of 21 CFR 803
  2. Review and update your MDR procedure to address the changes to 21 CFR 803 which are identified in the gap analysis
  3. Apply for an ESG WebTrader account for Low Volume/Single Reports
  4. Revise your training requirements for anyone responsible for MDRs:
    1. Complete all four applicable CDRH online training (http://bit.ly/CDRH-Learn)
    2. Pass a quiz demonstrating training effectiveness (http://bit.ly/TrainingExams)
    3. Review the draft procedure for potential errors or sections that are unclear
    4. Make any final revisions to the procedure based upon feedback from trainees
    5. Implement your revised procedure

If you need help completing the above steps, please contact Medical Device Academy by emailing Rob Packard, or by visiting the webpage for Medical Device Academy’s Complaint Handling and Vigilance group (http://bit.ly/chvg_mda).

Posted in: Complaint Handling

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Medical Device Management Review Procedure Improvements

management review Medical Device Management Review Procedure ImprovementsThe author provides suggestions for improving the writing of your medical device management review, scheduling meetings, and engaging top management. 

If the US FDA is not allowed to see Management Review meeting minutes, why were there one-hundred and seven 483 inspection observations against the Management Review process in FY 2012?

The US FDA is also not allowed to view records for internal audits and supplier audits, but there are 483 observations for these processes too. The FDA will assess the effectiveness of these processes by reviewing your procedures by verifying that you have a schedule, and you’re sticking to it. The ultimate test is to look for CAPAs initiated from these processes.

To avoid a 483 inspection observation against your Management Review process, you need four things:

  1. Procedure for Management Reviews
  2. Schedule for your Management Reviews
  3. Template to prevent errors
  4. The top management team that is trained

Writing a Medical Device Management Review Procedure

There is no requirement for a Management Review procedure in ISO 13485, but 21 CFR 820.20c states that the quality system shall be reviewed “at defined intervals and with sufficient frequency according to established procedure.” This frequency may be documented in the Quality Manual, or a Management Review procedure.

If you choose to write a procedure, keep it simple and reference a controlled template that includes each of the requirements listed above. Your procedure should also allow flexibility for each of the following probable events:

  1. Management Review requires rescheduling
  2. Some of the Management Team is unable to attend
  3. Some of the Management Team can only attend by conference call
  4. An action item from a previous review is left incomplete
  5. An action item is changed after the Management Review
  6. There is insufficient time available to review all the inputs during a single Review

Your Schedule for a Medical Device Management Review

The most common procedural requirements for the frequency of Management Reviews are:

  1. At least once per year
  2. Semi-annually
  3. Quarterly

Most companies choose to require a schedule of “at least once per year,” but what’s the point of reviewing quality system data from last February in January?

13485 Plus is a guidance document for the implementation of ISO 13485. Section 5.6.1 of the guidance document states, “If changes are planned or being implemented, more frequent reviews are normally needed.” Some companies even include this statement in their Management Review procedure. Unfortunately, most companies do not remember to change their schedule when they plan significant changes to their quality management system—such as mergers, new product launches, or an employee lay-off.

Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.

Conducting more than one Management Review also gives you the flexibility, assuming your procedure allows it, to review only some of the required inputs during a single Management Review. If you are short of time during your next management review, you could intentionally skip a required element. However, this approach also requires that you track which elements have been covered during your annual schedule and which elements were not. Any skipped elements must be covered at least once during the annual schedule for Management Reviews.

A Template for Medical Device Management Review

One of the most common nonconformities during an ISO audit is a finding that one of the required inputs or outputs was not included in the Management Review. The best way to ensure you don’t forget something is to use a template that is maintained by your document control process. This template should include the following:

  1. Eight Inputs (ISO 13485, Clause 5.6.2)
  2. Three Outputs (ISO 13485, Clause 5.6.3)
  3. Review of the Quality Policy (ISO 13485, Clause 5.3)
  4. Review of the Quality Objectives (ISO 13485, Clause 5.4.1)
  5. Review of the QMS effectiveness (ISO 13485, Clause 5.6.1)

The last item should be a conclusion in your management review meeting minutes. Often, the conclusions are worded in the following way, “The Quality Management System remains suitable, adequate and effective—with the exception of the areas that have been identified as requiring corrective actions in this management review.”

Engaging Top Management

Roles and responsibilities for the Management Review must be assigned. Some leaders choose to assign 100% of the Management Review to the Management Representative, and then the same executives complain that reviews are boring and take too long. To get the management team engaged, the responsibility for preparing reviews must be assigned to all members of the team. The Management Representative is responsible for “reporting to top management on the performance of the quality management system and any need for improvement.” Still, the ISO Standard does not imply that the representative cannot seek help from the rest of the team.

Each member of top management should be assigned responsibility for preparing and reporting on the part of the Management Review. This approach will ensure that all members of the management team are involved and engaged in the process. Your team may be assigned to work in pairs or smaller teams. Your team’s responsibilities may also be rotated to ensure that each member of the team is cross-trained and understands the importance of each Management Review requirement.

Before you can expect your management team to accept responsibility for preparing and reporting on the performance of the quality management system and improvement needs, Top Management needs the training to understand each of the requirements.

Free Webinar Training

Medical Device Academy also offers free webinar training on the Management Review process. If you are interested in training your top management team, please register for this management review webinar. It will also be available as a free recording for anyone that is registered. Registrants will also receive a copy of the webinar slide deck and a copy of the Medical Device Academy’s Management Review template.

 

Posted in: ISO Certification

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6 Points for Effective Training on Medical Device QMS Procedures

%name 6 Points for Effective Training on Medical Device QMS ProceduresThe author provides 6 points for conducting effective training on medical device QMS procedures, including questions to ask for building consistent procedures.

Your Quality Management System (QMS) needs to provide objective evidence (i.e., records) that your staff is trained on procedures they use, and that their training was effective. You must also establish documented requirements for competency. The following examples might help:

  1. A record of you attending a course is a training record.
  2. A record of your taking and passing an exam related to that course is a record of training effectiveness.
  3. A record of you performing a procedure, witnessed by the trainer, is a record of competency. Your resume can also be a record of competency.

Unless a change is trivial in nature, signing a piece of paper that states you read and understood a procedure does not demonstrate training effectiveness. Learning and training are active processes that require engagement and interaction.

In a previous blog (http://bit.ly/12PartSOPTemplate), I described a slightly different procedure structure with some extra sections. There are a number of benefits to that structure, one of which is that the structure facilitates training. The additional sections are referred to in this blog. Whatever template you use, consistency of structure, and presentation across your procedures makes the procedures easier to learn and increases usability.

6 Points to Consider for Effective Training on Medical Device QMS Procedures

  1. Training requirements. For a new procedure, decide early in your writing which roles require training, what content is needed, and to what level is competency necessary. The example below is a table from a Quality Auditing procedure. The table shows the different requirements for different roles. I prefer to put this information in the procedure document—where it is unlikely to be overlooked or forgotten.training procedure 6 Points for Effective Training on Medical Device QMS Procedures
  2. Open book? For each of the roles listed above, determine whether you need trainees to be able to follow the procedure without the document at hand, or to know the procedure, and be able to find what they need.
  3. Training method. One-on-one or group? Classroom style, on-job, or remote? This depends on your company, nature of the procedure, and your requirements above.
  4. PowerPoint or not? My preference is to walk trainees through the procedure, actually have them flipping the pages and writing notes on it. If I use PowerPoint, it’s to clarify the structure and emphasize important points.
  5. Control of training copies. Paper copies of procedures and forms used for training should be controlled. Your Document Control procedure should allow for clearly marked “Training” copies to be available before the effective date. Make sure your training also reminds trainees where to find the official released a copy of procedures after training is completed.
  6. Control of training material. Include your slides, training scenarios, quizzes, etc. in your document control system. Review and revise them each time you change a procedure. 

Building Consistent Procedures: Questions to Ask and Recommendations

Use a consistent structure for your procedures, then build a consistent training structure around that. The predictability in structure will improve the effectiveness of your training.

  1. Purpose. Why are we doing this? What is the outcome we are after?
  2. Scope. When do I use this procedure? When do I not, and what do I do as an alternative?
  3. References. How does this interface to other procedures? Turtle diagrams or interface maps are useful here
  4. Definitions. Unfamiliar jargon, and terms that are used in a very specific way in this procedure
  5. Risk. What risks does this procedure address? How does this affect the design of the procedure – why are we doing it that way? Refer to my earlier blog (http://bit.ly/12PartSOPTemplate) where I explain how to include this in each procedure
  6. The procedure. Walkthrough the flowchart, explain the accompanying notes, relate the procedure flow to the responsibilities and authorities outlined earlier in the procedure
  7. Records. What do I do with the completed records from this procedure? Where do I find a copy when I need it?
  8. Examples. I suggest a training version of the form (which should be available later for reference) with guidance and examples
  9. Practice. Provide a scenario and a blank form for trainees to work through, individually or in groups
  10. Testing. Check that the training has been effective. The role competencies that were defined earlier are the basis for the effectiveness criteria for a procedure. This training module may be enough to achieve that level, or a broader training program may be required to ensure operational level competence. See Rob Packard’s blog on training exams for more advice on testing (http://bit.ly/TrainingExams)

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What are the Essential Requirements for Medical Device CE Marking?

ER Table1 What are the Essential Requirements for Medical Device CE Marking?

The author reviews the essential requirements for medical device CE marking. Common mistakes to avoid, and the proposed EU regulations are also discussed.

Essential Requirements (ERs) are the requirements for safety and performance specified in Annex I of the three medical device directives. ERs are divided into Part I (i.e., – general requirements) and Part II (i.e., – requirements for design and construction). Evidence of conformity must be provided for all general requirements in Part 1 for all devices—regardless of risk classification, design, or construction. The Design and construction requirements in Part 2 may be not applicable, depending upon your device.

When a Notified Body reviews your Technical File or Design Dossier for CE Marking, the auditor must verify that you have addressed each ER. This is typically demonstrated by providing an ER Checklist (ERC). You can find a template for an ERC on the International Medical Device Regulators Forum (IMDRF) website (http://bit.ly/IMDRFDoc) in Appendix A (see example in Figure 1 below) of the GHTF Guidance document explaining the use of a Summary Technical Document (STED) to demonstrate conformity with the principles of safety and performance (http://bit.ly/GHTFSTEDGuidance).

Figure 1 ERC Example What are the Essential Requirements for Medical Device CE Marking?

Figure 1: Example of an ERC

To demonstrate compliance with the ERs, you must provide the following information by filling in the four columns of the ERC:

  1. Applicability to your device,
  2. The method used to demonstrate conformity with the ER,
  3. Reference to the method(s) used, and
  4. Reference to the supporting controlled documents.
Subparts & Common Mistakes

Completing the ERC would be easy if there were only 13 ERs, but eight of the 13 ERs have multiple requirements. For example, ER 13.3 has 14 subparts (i.e., – 13.3a through 13.3n). Each subpart must be addressed when you complete the columns of the ERC table. If any of the parts in ER 7-13 do not apply to your device, you need to provide a justification. For example, ER 11 and its subparts do not apply to devices that do not emit radiation. This justification must be documented in the ERC for each subpart.

When you write your justification for the non-applicability of an ER, you need to be careful to provide a justification for each part of the requirement. For example, there are three sub-parts to ER 7.5. Each part is a separate paragraph, but these are not identified by a letter, as is done in ER 13.3 and 13.6. Instead, each subpart is a separate paragraph. Within those paragraphs, there is further room for confusion. For example, the third paragraph states that if you use Phthalates in a product that is intended for women or children, then you must provide a justification for its use in the technical documentation, in the instructions for use, within information on the residual risks for these patient groups (i.e., –women and children) and, if applicable, on appropriate precautionary measures.

Proposed EU Regulations

The proposed EU Medical Device Regulations (MDR) are organized into Articles and Annexes–just like the current EU Directives, and the ERs will still be the first Annex of the MDR. However, there will be 19 ERs instead of 13. The early reviews of the proposed regulations indicated that there were no significant changes. Still, I have learned the hard way that you should always go to the source and verify the information for yourself. The general organization of the Essential Requirements is still the same. Nevertheless, several significant changes will require providing additional documentation in your Technical File or Design Dossier for CE Marking. Most companies will probably submit a revised ERC to address the new requirements, but you may want to read Medical Device Academy’s review of the new ERs (http://bit.ly/NewERCGap) and prepare accordingly.

Essential Principles Checklists

Health Canada has an Essential Principles checklist (EPC) that is similar to the European ERC, and Australia has a similar document (http://bit.ly/EPCTGA) with only a few minor differences. The Global Harmonized Task Force (GHTF) created an earlier version in 2005 (http://bit.ly/EPSafetyPerf). Health Canada will typically accept your ERC developed for the European Medical Device Directive (MDD), but a gap analysis should be performed against the Australian Regulations.

Now that the ENVI vote has passed (http://bit.ly/ENVIVotepasses), I asked a new consultant working for me to create a template for the new Essential Requirements in the new EU MDR regulations. You can download the MDD ERC Template and the new EU MDR Template. This new template also indicates the items that were recently modified (see the red lines).

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What Does the CE Mark Mean, and What is its Purpose?

CE Marking Examples What Does the CE Mark Mean, and What is its Purpose?

The author answers the question of what does the CE Mark means, what its purpose is related to medical devices and regulatory requirements, if applicable.

To facilitate trade throughout the European Economic Area (EEA), products need to be identified as compliant with regional and national regulations. In the EEA, this identification is the CE Mark. “CE” is not an acronym. The mark indicates compliance of your product with the essential requirements in the applicable directive. In the case of medical devices, there are three directives:

  1. Medical Device Directive, 93/42/EEC (http://bit.ly/M5MDD),
  2. Active Implantable Medical Devices Directive, 90/385/EEC (http://bit.ly/AIMDDirective)
  3. In Vitro Diagnostics Directive, 98/79/EC (http://bit.ly/currentIVDD).

Prior to the existence of these three directives, medical devices were compliant with the regulations of individual member states. These regulations were extremely detailed and created a barrier to the transport of products between the member states. With the implementation of the new approach directive (http://bit.ly/Resolution85), companies were able to CE Mark medical devices in accordance with one of the three device directives, and medical device products began to flow smoothly throughout the EEA.

Notified Body Numbers

The images at the top of this blog posting are examples of CE Marks from two of the largest medical device Notified Bodies. The four-digit numbers identify the Notified Body (NB) that issued the CE Certificate for the medical device. This number is only used for medical devices requiring NB involvement. Therefore, non-sterile Class I medical devices that do not have a measurement function are required only to have the “CE” on their labeling. All other medical devices are required to have the “CE” with the NB four-digit number. If one of the Competent Authorities (CAs), the equivalent to the U.S. FDA in each member state, wants to determine which Notified Body is authorizing the CE Marking of a medical device, the CA will look-up the four-digit number on the following NB database (http://bit.ly/NBDatabase).

How to Reproduce the Mark

It is the legal manufacturer’s responsibility to design their labeling with the CE and NB number—if applicable. This labeling is included in the company’s Technical File, and the NB reviews the Technical File for compliance with the essential requirements in one of the three device directives. For medical devices, the instructions for CE Marking are defined in Annex XII of 93/42/EEC. For active implantable devices, the requirements are found in Annex 9 of 90/385/EEC. For in vitro diagnostic devices, the requirements for CE Marking are found in Annex X of Directive 98/79/EC.

These three Annexes are identical and provide a graduated drawing showing the exact proportions of the “C” and “E” relative to one another. These Annexes also state that “”The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.”” You can obtain a free download of the mark on the Europa website (http://bit.ly/DownloadCE).

The four-digit NB number is intended to be the same boldness and font as the “”CE”” characters. Therefore, NBs have interpreted the requirement to specify numbers that are at least half the height of the “C” and “E”—or at least 2.5 mm. Each NB also provides instructions to legal manufacturers on how to present the CE characters with their four-digit NB number. Usually, there are a couple of different orientations that are allowed by the NB. For small products, it may not be possible to mark the device with a “C” and “E” that is at least 5 mm. Therefore, the directives waive this minimum dimension for small-scale devices. Most companies, however, will place a “C” and “E” on their labeling that is at least 5 mm in height, instead of marking parts with a “CE” that is illegible.

Use and Misuse of CE Marking

Most companies want to use CE Marking on all product labeling, even for products sold outside the EEA, because other countries recognize it and associate it with safety and performance. It is also acceptable to use the “CE” in product literature. However, it is important that it appears next to product images or descriptions that have a valid CE Certificate. It is not acceptable to use the “CE” in a way that it might imply that other products have a CE Certificate when the products do not. It is also not acceptable to use the “CE” in a way that it might imply a corporate entity is “CE Marked.” CE Certificates are for products—not for companies.

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Medical Device CE Marking: Writing a Classification Rationale

%name Medical Device CE Marking: Writing a Classification RationaleThe author reviews considerations in “how to” write a classification rationale for medical device CE marking (i.e., questions for applying classification rules).

 CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier). One of the requirements of this technical documentation is to establish the risk class of a device in accordance with the classification rules in Annex IX. The requirement to include this classification rationale in the Technical File is not well defined in Article 9, Classification, of the Medical Device Directive (http://bit.ly/M5MDD), but the guidance document for Technical Documentation (http://bit.ly/NBMED251Rec5) clearly defines this requirement in Section 3.2 (viii). Establishing a classification rationale is the first step to establishing the regulatory pathway that will be required to CE Mark your medical device.

What are the Classifications?

There are four different classifications of medical devices in Europe: Class I, Class IIa, Class IIb and Class III. These four classifications are also referred to as “risk class.” The lowest risk classification is Class I, and the highest risk classification is Class III. Class IIa is considered a “medium risk,” while Class IIb is considered a “high risk” medical device. Notified Body involvement and a CE Certificate from the Notified Body is required for almost all medical devices distributed in Europe, however, Class I devices that are non-sterile and do not perform a measurement function do not require Notified Body involvement. Class I devices that are sterile are often referred to as “Class I-S,”but this is not a term used in the Directive. The same is true of “Class I-M” for Class I devices with a measurement function.

Applying the Rules for Medical Device CE Marking

In order to apply the classification rules as defined in Annex IX of the MDD, the following questions must be answered for the device or device family:

  1. Is the device invasive? –  Invasiveness of a device is an important criterion, because non-invasive devices are generally Class I, and there is typically no Notified Body involvement required for these devices.
  2. Is the device surgically invasive, or invasive with respect to body orifices?  If a device is surgically invasive with respect to a body orifice, Rule 5 is the most likely classification rule. For all other devices that are surgically invasive, the duration of use is important
  3. How long is the device used inside the body? The primary difference between Rules 6, 7 and 8 is the duration of use. In general, permanent implants are subject to Rule 8, and are Class IIb devices. The other surgically invasive devices are generally Class IIa devices. Devices under Rule 6 are for “transient” use (i.e., – intended for continuous use for less than 60 minutes). Devices under Rule 7 are for “short-term” use (i.e., – intended for continuous use for between 60 minutes and 30 days.). There are multiple exceptions to each rule, and these exceptions should all be considered.
  4. Is the device electrically powered (i.e., – an active device)? Active devices are subject to rules 9, 10, 11 and 12.
  5. Do any of the “Special Rules” apply? It is recommended to actually start with Rules 13-18 to ensure that one of the special rules do not apply. For example, if you are making blood bags, there is no need to read anything in Annex IX except Rule 18.
Guidance Document for Classification

Annex IX defines the classification rules for Europe, but there is also a guidance document (http://bit.ly/EUClassification) published that helps to explain the classification rules with examples. This guidance document is extremely important, because it provides clarification of rules based upon interpretations that have been made by Competent Authorities with Notified Bodies and companies. For example, critical anatomical locations are defined in Section 3.1.3: “For the purposes of the Directive 93/42/EEC, ‘central circulatory systemmeans the following vessels:…”.

When you write a classification rationale for your technical documentation, it is important to reference this document—as well as Annex IX of the MDD. Your rationale should address each of the questions above for applying the classification rules. In addition, your rationale should indicate that none of the “Special Rules” (Rules 13-18) are applicable to your device or device family.

Mixed Classifications

It is possible to have a device family, contained within one Technical File or Design Dossier, that has more than one Classification. For example, you could choose to group a family of vascular grafts together in one Technical File that are permanent implants and non-absorbable. Normally, these devices would be Class IIb in accordance with Rule 8. However, if one or more of the grafts is intended for vessels included in the central circulatory system, then these grafts would be Class III devices. If a graft can be used for either indication, then the higher classification should be applied.

Proposed EU Regulations

On September 26, 2012, the European Commission released a draft proposal for a new medical device regulation. The expected implementation transition period for these proposed regulations is 2015-2017. In Annex II of the proposed regulations (http://bit.ly/EUProposal), it specifies that the risk class and applicable classification rationale shall be documented in the technical documentation. This appears as item 1.1e) under the heading of “Device description and specification.”

The MDD defines the classification rules for medical devices in Annex IX, while in the proposed EU regulations classification, rules are now in Annex VII. The MDD also has 18 rules, while the proposed regulations have 21 rules. In order to download a Gap Analysis of the Classification Rules for CE Marking, please visit the following page on this website: http://bit.ly/gapanalysiscmda.

If you need assistance with medical device CE Marking, or you are interested in training on CE Marking, please contact Medical Device Academy at: rob@13485cert.com. Medical Device Academy is developing a webinar series specifically for this purpose. You can also call Rob Packard by phone @ 802.258.1881. For other blogs on the topic of “CE Marking,”please view the following blog category page: http://robertpackard.wpengine.com/category/ce-marking/

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Why the FDA 510k Process Needs to Change Now: A Proposed Solution

The author says three factors are accelerating the need for change to the current FDA 510k process and offers a proposed solution.

%name Why the FDA 510k Process Needs to Change Now: A Proposed SolutionWhen a company’s marketing literature tells you how a new device is different from competitor products, and the 510k summary for the same new device states that it is “substantially equivalent,” you can understand why the FDA may not fully support the 510k process for innovative, medium-risk devices.

There are many things wrong with the FDA 510k process, but the concept of using a predicate device and demonstrating equivalence is inherently a wrong approach for innovative devices. A preliminary report about the 510k process was released in 2010 (http://bit.ly/510kreport). The report states, “While the concept of ‘substantial equivalence to a predicate’ is generally reasonable, CDRH’s application of this standard has, in some instances, raised concerns.” Specifically, the use of predicate devices that were withdrawn from the market due to issues of safety or effectiveness, and the use of so-called “split predicates” may not ensure patient safety or device efficacy.

The FDA attempted to address issues identified in the report by issuing a draft guidance document for 510k submissions, but the industry hated it. The FDA has also gradually requested more clinical study data to demonstrate that the new device is substantially equivalent to the predicate device. This practice results in unexpected delays and much higher costs of regulatory approval. The FDA’s published guidance for 510k content (http://bit.ly/510kContent) indicates that “Clinical data is not needed for most devices cleared by the 510(k) process.” However, more than 10% of 510k submissions now require clinical data because the 510k for predicate devices included clinical data to demonstrate safety and effectiveness.

More recently, the FDA issued a draft guidance document for the De Novo process (http://bit.ly/DeNovoGuidance). The De Novo process allows the FDA to reset the submission requirements for devices that are not substantially equivalent and specify new requirements. The process has been used most for new In Vitro Diagnostic (IVD) products, and it is quite similar to the concept of Common Technical Specifications (CTS) introduced for IVD products in Europe.

Why the FDA 510k Process Needs to Change Now

The simultaneous confluence of three factors is accelerating the need for change in the 510k process. First, the cost of healthcare is skyrocketing. Therefore, patients and healthcare providers are desperately searching for less expensive treatment solutions. Second, insurance providers are demanding clinical evidence that new products are more effective than existing products that cost less. Third, evidence-based medicine is becoming mainstream. Physicians are no longer accepting the word of salespeople and marketing literature. Instead, physicians demand clinical data demonstrating that products are safe and effective. Users also want detailed information regarding patient selection criteria.

The collision of these three factors has exponentially increased the value and importance of clinical data. Still, only 10%+ of the 510k cleared devices to have clinical data at the time of product launch. Regulatory clearance to market a product is nearly useless if the product is not reimbursed, and users will not adopt its use. The modular Premarket Approval (PMA) process supports (http://bit.ly/PMAmethods) the need for preliminary safety data before clinical use, followed by a clinical study to demonstrate efficacy. However, 510k products are lower in risk and efficacy and can often be demonstrated with simulated use, animal testing, and cadavers.

As medical devices become more complex and innovative, bench-top testing and pre-clinical testing is not always adequate to demonstrate safety and efficacy for 510k products. Complex and innovative devices are extremely difficult to predict how the devices will interact with a broader population of users and patients, and it is difficult to predict the long-term effects of the devices—beyond the duration of a premarket, clinical study.

The PMA process requires premarket clinical data, but PMAs requires exponentially greater amounts of data than a 510k submission, and the FDA requires supplemental approval of almost every minor change (e.g., – changing a component supplier, or changing a test method). If the PMA process is too burdensome for most devices, and the 510k process is not adequate, what is the right process for the next generation of devices?

The De Novo process offers one solution, but it is still a premarket notification process. For the De Novo process to be useful for innovative devices, a Special Controls Guidance Document needs to include a requirement for both premarket clinical studies and Post-Market Surveillance (PMS).

Pilot Parallel FDA-CMS Review Process

In 2011, the FDA initiated a pilot program to allow companies to have PMA and CMS (http://bit.ly/Medicare-Medicaid) review processes occur in parallel (http://bit.ly/ParallelReview). The concept behind this pilot program is that the same clinical data must be reviewed for PMA approval and CMS reimbursement. If the pilot program is effective, products will be approved and reimbursed at the same time. However, this pilot program is only applicable to PMA products at this time. This program could be expanded to 510k products, where clinical data is presented as part of the application, but most 510k products do not warrant a clinical study.

Another Solution

The best tool to measure the safety of a new device is a clinical study, but U.S. clinical studies focus on demonstrating efficacy. Therefore, the FDA should consider using smaller clinical studies, without comparisons to predicate devices, to demonstrate safety rather than efficacy. This is the approach used by European Notified Bodies for medium and high-risk, innovative devices. This approach can also be integrated with a Special Controls Guidance Document for De Novo products.

For complex, innovative devices, the efficacy of the device is not reliably measured by clinical studies, because outcomes are highly dependent upon users. Premarket clinical studies can only estimate efficacy due to the small number of users. The lack of accurate efficacy predictability is why the FDA requires PMS for many PMA products. The best tool to measure efficacy is Post-Market Clinical Follow-up (PMCF) studies—not the premarket clinical studies the FDA uses to evaluate PMA applications. This is also the type of data that is required for CMS reimbursement and physician adoption.

Innovative devices are forcing regulations to evolve. The goal of regulators should be to produce a best-in-class method of evaluating which devices should be approved, reimbursed, and adopted as the standard of care.

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