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IFU Validation and Post-Market Surveillance – A risk-based approach

This article describes how to perform IFU validation prior to commercialization and how to conduct post-market surveillance to ensure that your IFU continues to be suitable as your user population and patient population expand.

IFU Validation and PMS IFU Validation and Post Market Surveillance   A risk based approach

Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor IFU. However, if the IFU is created by a marketing person, the IFU will explain how your product is total different from the competitor product. Neither approach is effective.

Creating a risk-based IFU

EN ISO 14971:2012 identifies deviations between the ISO 14971:2007 international standard and the three EU Directives. However, deviation #7 is specific to labeling and instructions for use. Even if your product is not CE marked, you should be developing a risk-based approach to IFUs. The first priority of risk controls is to eliminate and reduce risks by design, manufacture and selection of materials. The second priority is to implement protective measures such as alarms to warn users of risks. The last priority for risk controls is to inform users of residual risks. The best practice is to utilize a risk traceability matrix to document each of the risk controls you implemented to eliminate and reduce risks of hazards identified.

The EN version of ISO 14971 will not allow you to reduce risks quantitatively in your risk assessment for information provided to users about risks, because this type of risk control is not completely effective. However, you are required to verify that each residual risk is disclosed to users in your IFU and you must validate that your warnings, precautions and contraindications are adequately identified such that users understand the residual risks. You are also required to determine any user training needed to ensure specified performance and safe use of your medical device in accordance with ISO 13485:2016, Clause 7.2.1d. Clause 7.2.2d) requires that your company ensure that user training is made available. Any user training you provide should also be validated for effectiveness.

When to perform IFU validation

Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, your company and they are highly skilled in the specific procedures your device will be used for. After your own experts have make their final edits to your draft IFU, you now need a “fresh set of eyes.”  The best approach is to validate the effectiveness of your IFU with potential users that don’t know you or your company. If your product requires animal performance testing or human clinical studies, you could use these studies to validate your IFU. However, I recommend conducting a simulated use study prior to conducting animal or human studies. Conducting a simulated use study prior to animal and human studies can prevent deviations from your documented protocols that were caused by inadequate review of the IFUs.

Methods of IFU validation

The best method for validating your IFU is to perform a simulated use study or human factors study. The FDA published a human factors guidance document that can help you assess the risk of human factors and ergonomics. The FDA guidance requires that you identify your intended user population(s). For each individual population of users, you are required to have a minimum of 15 users for your study. If your product is not for specific indications, you may be able to randomly select 15 users at a few sites. However, if your device is intended for two different specialties, then you need to 30 users–15 for each specialty.  I recommend recording a video of simulated use studies too. Videos identify small details that you might miss, and clips from the videos are useful in creating training videos for future users.

Gathering Post-Market Surveillance

Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitoring adverse event databases, your own complaint database and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated with regard to severity and probability of occurrence of harm. In fact, clinical studies and PMS are the only way you can gather data regarding probability of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions specifically targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”

Revalidation of IFU after labeling changes

Changes to labeling and IFUs should always be considered design changes and may require revalidation. If the change is in response to a complaint or CAPA, then it is crucial that you revalidate the IFU and labeling to verify effectiveness of your corrective action. Any validation should be documented, reviewed and approved prior to implementation and acceptance criteria should be determined ahead of time. Your acceptance criteria should be quantitative so you can objectively determine if the change is effective or not. You might be able to copy your previous IFU validation protocol or simulated use protocol and simply repeat the validation exactly as you did before with new users. However, sometimes the reason why the IFU was not 100% effective in the past is that the risk you are addressing in the revised IFU was not evaluated adequately in the original simulated use protocol.

New webinar for risk-based IFU validation and PMS

If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs and performing post-market surveillance to monitor the effectiveness of your IFU, then please click on the webinar link below.

IFU Validation Webinar Button 300x62 IFU Validation and Post Market Surveillance   A risk based approach

 

Posted in: Clinical Studies & Post-Market Surveillance, Validation

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DHF Required for a Class I Device? At least 67%…

Is a DHF required appears to be a simple yes/no question? If you reword the question, however, you get a very different answer.

Is a DHF required DHF Required for a Class I Device? At least 67%...

If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% less documentation for the design of a Class 1 device.

The FDA shared a presentation on design controls in 2015.

In that presentation, the agency identified six, Class 1 product classifications that require design controls, while thousands of Class 1 product classifications do not require design controls. Despite the lack of design controls, manufacturers must still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs) and design changes may still require revalidation prior to implementation.

Why is a DHF Required for Class 2, but Not for Class 1?

Class 1 devices are simple devices that are already on the market and have a history of clinical safety. Class 2 devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a greater risk for Class 2 devices. When you design a Class 1 device, you still have to determine what your design specifications will be, but you don’t need: 1) to review and approve design inputs, 2) a procedure to document your design process, 3) to document formal design reviews, and 4) to create a design plan.

In the 1997 guidance document for design controls, the FDA states that a design transfer procedure should include at least three basic elements:

  1. design and development procedures should include a qualitative assessment of the completeness and adequacy of the production specifications;
  2. procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved; and
  3. procedures should ensure that only approved specifications are used to manufacture production devices.

The first of these basic elements is not required for Class 1 devices, because product specifications for most Class 1 devices are simple. The other two requirements are basic principles of document control and configuration management. Therefore, you still need a design transfer procedure for Class 1 devices but you don’t need to include the first element that relies upon design and development procedures.

If you have a Class 1 device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you must still validate and re-validate the process in accordance with 21 CFR 820.75. Class 1 products also require, a device master record (DMR) in accordance with 21 CFR 820.181.

What is Not DHF required?

Needed for Class I (67%)

  1. Approved Design Outputs
  2. Labeling Procedure
  3. Approved Labeling
  4. Sterilization Validation Procedure
  5. Sterilization Validation Protocol and Report
  6. Design Transfer Procedure
  7. Approved DMR
  8. Design Change Procedure

Needed for Class II and Class I requiring Design Controls (100%)

  1. Design Control Procedure
  2. Design Plan
  3. Approved Design Inputs
  4. Approved Design Outputs
  5. Labeling Procedure
  6. Approved Labeling
  7. Sterilization Validation Procedure
  8. Sterilization Validation Protocol and Report
  9. Design Transfer Procedure
  10. Evidence of at least 1 Design Review
  11. Approved DMR
  12. Design Change Procedure

Therefore, although you do not technically have to have a DHF for a Class 1 products, the difference between the two categories is the following elements:

  1. Design Control Procedure
  2. Design Plan
  3. Approved Design Inputs
  4. Evidence of at least 1 Design Review

When an FDA inspection occurs, the investigator will review your design control procedure and then audit your DHF in accordance with your design plan.

When you have a Class 1 device, you are not typically inspected unless there is a problem and when ORA inspectors perform an inspection for Class 1 devices the inspector looks for evidence of items in first list.

If you are interested in learning more about design history files (DHF), please check out our DHF webinar.

Posted in: Design Control

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Checking adverse event history for your device and competitors

Article explains checking adverse event data for medical devices as part of design and development, risk management and post-market surveillance.

TPLC Database Checking adverse event history for your device and competitors

When should you be checking adverse event history?

There are three times when you should be checking adverse event history:

  1. when you are planning a new or improved medical device and you want to know how current devices on the market malfunction (design and development planning),
  2. when you are identifying hazards associated with a medical device as part of your risk management process, and
  3. when you are gathering post-market surveillance data about your device and competitor devices.

Where should you be checking adverse event history?

Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of adverse events in Europe. Unfortunately, you can’t access Eudamed. The Eudamed database is only available to competent authorities at this time. The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database. The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database.

Are there other public databases for checking adverse event history?

Yes. The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available. The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. There are other countries that also have public registries.

When will checking adverse event data for Europe be possible?

The Eudamed database for Europe was created in 1999 by the German organization DIMDI. In 2000 the responsibility for the database was taken over by the European Commission. The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.

When you collect post-market surveillance data, which data should you collect?

Searching for post-market surveillance data should be performed on a frequency that is risk-based. If you have a brand new device, a high risk device or a device that is implanted; post-market surveillance data should be reviewed frequently–either monthly or quarterly. In fact, the new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices. It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your own complaint data, and you should be searching for journal articles that may include adverse event data–possibly associated with a clinical study.

Available Resources

If you want to learn more about post-market surveillance data collection, please visit our webinar page. There is also a procedure for Post-Market Surveillance (SYS-019).

Posted in: Risk Management

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Updating Training Procedure for Compliance with ISO 13485:2016

This article explains my process for updating training procedure SYS-004 for compliance with ISO 13845:2016 while the procedure was also simplified.

Training and Competency 1 Updating Training Procedure for Compliance with ISO 13485:2016

In addition to weekly blogging for the Medical Device Academy website and the FDAeCopy website, I am also updating each of my procedures for ISO 13485:2016 compliance. This week the training and competency procedure (SYS-004) was updated. You are updating your own procedures for compliance with the revised standard, but are you making any other strategic changes at the same time?

Changes to Training in ISO 13485:2016

The primary change to Clause 6.2 in ISO 13485 was the addition of the phrase, “shall document the process(es) for establishing competence, providing training and ensuring awareness.” This doesn’t represent a change in the intent of the standard, but it does signal that certification bodies should be emphasizing the importance of assessing effectiveness of training and competency–not just verifying the existence of training records.

Updating Training Procedure

The original version of SYS-004 had 8 pages and includes three different flow charts to explain the process. The procedure also required the use of a training plan for each employee. While I agree that training should be planned by managers, if you make this a formal requirement with a controlled form it creates an unnecessary burden for managers.

Therefore, when the procedure was updated to the requirements of ISO 13485:2016, the procedure was also simplified for easier implementation by start-up companies. When you update your procedures you might look for similar opportunities to simplify and streamline the processes.

The updated procedure now has suggestions for how to consolidate certain roles for smaller companies. The procedure still references a training record for documenting training, but now there is also a reference to a training matrix to help document training requirements for each employee.

The FDA also requires that there are documented training requirements. Therefore, the procedure identifies the need to create a job description that includes training and competency requirements. The procedure does not, however, require that the job descriptions be maintained as controlled documents. If your company has multiple people with the same job function (e.g., customer service), then it might make sense to have a controlled document that is a job description for customer service. A company with 4 employees do not need controlled documents and instead a unique record for each employee makes more sense.

Updating Training Procedure to Explain How to Complete Forms?

Another option is to make your procedure very detailed to explain how to complete each section of a form, such as the training record (FRM-002) or the training matrix (FRM-026). However, I see very few managers struggle with completing training records. Therefore, instead I plan to record a brief training webinar that explains how to fill in the forms. This will be provided as a free update to anyone that purchases the training competency procedure. This makes it easier to review the procedure for regulatory compliance and puts the details on how to complete forms in the training curriculum where it belongs.

If you have questions about how to update any of your procedures to ISO 13485, please email me at rob@13485cert.com. Maybe I’ll use your question as a topic for a future blog.

Posted in: ISO 13485:201x, ISO Certification

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FDA eCopy Website – Printing and Shipping Resources

Blog describes the new FDA eCopy website to help you successfully deliver your first FDA eCopy and to troubleshoot problems with eCopy submissions.

FDAeCopy Logo 1024x478 FDA eCopy Website   Printing and Shipping Resources

Easlier today I posted a new blog on the topic of “Pre-submission Meeting Request Feedback Methods” on the FDA eCopy website. If you are almost done with preparation of your 510k submission or a pre-submission meeting request, you can save yourself some time and prevent mistakes by visiting my new FDA eCopy website. In October the website and service was launched, and the first customers hired us to help them with printing and shipping their FDA eCopy submissions. In January the first blog was posted, and I will continue posting weekly blogs about 510k submissions and the FDA eCopy process to help you streamline your own printing and shipping of FDA eCopy submissions.

What’s on the FDA eCopy Website?

The FDA eCopy website includes a weekly blog on topics related to FDA 510k submissions, pre-submission meeting requests and other types of FDA submissions that require an FDA eCopy. In addition to the home page which is the weekly blog, you will also find links to the following useful resource pages:

  • Share eCopy Now – a page that explains how to submit content to FDA eCopy for your submission using Dropbox or some other file sharing service
  • eCopy Service – a page explaining the FDA eCopy service
  • Formatting Checklist – a page that explains our FDA eCopy checklist created for internal use to ensure that 100% of FDA eCopy submissions are successfully uploaded by the FDA; the page also has a form for downloading our checklist if you want to create your own FDA eCopy
  • Price of Service – a page describing pricing of this printing and shipping service
  • Arrival Time – a page that explains when your FDA eCopy will arrive at the FDA in Silver Spring, MD
  • FedEx Tracking – if you click on the image of the FedEx airplane on the FDA eCopy website, it will immediately take you to FedEx tracking and you can enter your own tracking number to track your FDA eCopy shipment (don’t worry, it will arrive at 10am and you will receive an acknowledgement just after 4pm the same day)

From now on, most of my blog posts related to 510k submissions will be found the FDA eCopy website. There is one blog specific to eCopy submissions on this website that you might be interested in. Click here if you want to learn how to eliminate hidden system folders from your FDA eCopy flash drive.

If you want to learn more about 510k submissions in general, consider attending one of the live 510k workshops.

Posted in: 510(k)

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MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

Article overviews of the new MEDDEV 2.7/1 rev 4 for clinical evaluation of medical devices, including a quality plan to comply with the new revision.

MEDDEV 271 rev 4 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

What’s new in MEDDEV 2.7/1 rev 4 for clinical evaluations?

The third and fourth revision both give manufacturers three choices: 1) a clinical literature review, 2) performing a clinical study, and 3) a combination of literature review and performing a clinical study. However, the fourth revision is completely re-written, the fourth edition is 19 pages longer and it is now much harder to use the “literature only” route. The fourth revision includes stringent requirements for demonstrating equivalence between another device and your device. Therefore, many companies are now struggling to update their clinical evaluation reports to satisfy this new guidance document.

Overview of the content in MEDDEV 2.7/1 rev 4

The third and fourth revisions of the guidance both have a 5-stage process for clinical evaluations, but in the third revision only articulated stages 1 through 3 as stages leading up to writing a clinical evaluation report. The figure in section 6.3 of revision 4 now identifies a planning Stage 0 and the writing of the clinical evaluation report is referred to as Stage 4. Therefore, there is a lot more detail describing the planning and report writing stages than there was in revision 3. In addition, Stage 2 (Appraisal of clinical data) has been expanded from a single page to eight pages.

Based upon the above changes, you can infer that Competent Authorities have been unsatisfied with the quality of clinical data being provided to support the essential requirements for safety and performance. In turn, Notified Bodies are expected to be much more critical of the data presented and more guidance is provided to manufacturers. There is also much more guidance and more examples provided in the appendices, while the 12-page clinical evaluation checklist that was provided in revision 3 has been replaced by one page of bulleted items for Notified Bodies to consider.

Demonstration of equivalence

It is no longer sufficient to list several devices that are similar to your device and include those devices in your search of clinical literature. Now you may only select one device for equivalence. You must also provide a thorough analysis of equivalence with that device on the basis of clinical, technical and biological characteristics. This comparison includes providing drawings or pictures to compare the size, shape and elements of contact with the body.

Updating clinical evaluations

The new European Medical Device Regulations (EMDR) is expected to specify minimum requirements regarding the frequency of updating clinical evaluations, but MEDDEV 2.7/1 rev 4 discusses this in section 6.2.3. The frequency of updating your clinical evaluations must be justified and documented. Many considerations for this justification are discussed, but the end of that section indicates that devices with significant risks (e.g., implants) require at least annual updates to the clinical evaluation report. For devices with non-significant risks, and where the device is well established (e.g., a long clinical history), 2-5 years is the range of possible frequency. Longer than 5 years is not allowed.

Who should perform clinical evaluations?

Many device manufacturers are receiving nonconformities, because the evaluators are not sufficiently qualified or the qualifications are not documented. The qualifications must follow 6.4 of the new guidance and the qualifications set by your company should be documented in your procedure for clinical evaluations. You will need to document these qualifications with more than an abstract, but you will also need to present a declaration of interest for each evaluator. Evaluators need knowledge in clinical study design, biostatistics, information management, regulatory requirements and medical writing. Evaluators also need knowledge specific to the device, its technology and its application. Evaluators must also have a higher education degree in the field and 5 years of experience or 10 years of experience if they do not have a higher education degree. Due to the breadth and depth required of qualifications required, it may be necessary to assemble a team to perform evaluations.

Creating a quality plan for compliance with MEDDEV 2.7/1 rev 4

There are seven steps that need to be included in your quality plan for compliance with MEDDEV 2.7/1 rev 4:

  1. update your external standards to replace MEDDEV 2.7/1 rev 3 with MEDDEV 2.7/1 rev 4
  2. revise your procedure and associated templates for a literature review and clinical evaluation report to meet the requirements of MEDDEV 2.7/1 rev 4
  3. document the qualifications of evaluators for clinical evaluations
  4. document a plan/schedule for updating your clinical evaluation reports for each product family
  5. train evaluators, regulatory personnel and any applicable internal auditors on the requirements of MEDDEV 2.7/1 rev 4 and updated procedures and forms
  6. begin updating clinical evaluations according to your plan
  7. perform an internal audit of your clinical evaluation process

Learning more about MEDDEV 2.7/1 rev 4

If you are interested in learning more about this revised guidance document, please register for our live webinar on Friday, January 27 @ Noon EST by clicking on the button below.

Click Here 300x115 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

Posted in: CE Marking, Clinical Studies & Post-Market Surveillance

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Control of Records – Updating Your Procedure for ISO 13485:2016

Article reviews changes recommended for your control of records procedure to ensure compliance with ISO 13485:2016 and applicable regulatory requirements.

VA File Storage Control of Records   Updating Your Procedure for ISO 13485:2016

Nine months have already passed since the release of the 2016 version of ISO 13485. In 2015, you were told to update your quality system procedures early before the new European Regulations were released. There is a three year transition period, and you decided to do it next year. Now it’s 2017. It’s time to update your procedures.

Quality Plan for Revising Procedures to ISO 13485:2016

My plan is to update one procedure each week from the 2003 version of ISO 13485 to the 2016 version. Some of the procedures were already updated last year, but just like you I decided to finish the work next year. For the next 6 months we will be busy revising procedures.

Training on the requirements for Control of Records

In addition to a procedure for control of records, you also need to train employees on good documentation practices. Originally I created a webinar called “GDP 101” that combined control of documents, control of records and training. Several people recommended that the webinar be revised to focus on control of records. Therefore, new webinars will be recorded each week to explain the updates to each procedure and to ensure that there is a training webinar for each procedure.

Three Generic Updates to Control of Records Procedure (SYS-002)

When you update a procedure, you need to do more than change the reference to the version of ISO 13485. For all procedures I recommend that you make three general improvements:

  1. identify a risk-based approach for that procedure,
  2. identify methods for documenting training effectiveness and competency, and
  3. verify that you have updated the procedure to address regulatory requirements.

In the case of control of records, the most important records should have more rigorous controls and more frequent monitoring of record control to ensure it is effective. For example, the following critical records are frequently sampled by FDA inspectors and should be carefully stored, organized and monitored:

  • CAPAs
  • Complaints
  • Adverse Event Reports
  • Recalls
  • Nonconforming Material Records
  • Design History Files
  • Training Records

FDA inspectors are not permitted to review records of your management reviews, internal audit records and supplier records. However, all three records will be sampled by certification bodies and therefore these three records exempt from the requirements of 21 CFR 820.180 should also be a priority for risk-based control of records.

To address the third of the generic procedural updates, you should be aware that the new EU Medical Device Regulations are expected to increase the required record retention period for non-implant devices from 5 years to 10 years. Implants are expected to remain at 15 years.

Three Procedure-Specific Updates to Control of Records Procedure (SYS-002)

In addition to the generic procedural updates, there are three changes in the Standard that are specific to control of records. First, in the section for control of documents (renumbered as Clause 4.2.4) there is now a requirement to prevent the deterioration and loss of documents.

Second, there is now a requirement in Clause 7.3.10 for maintaining design and development files for devices. This may have been previously been addressed as a requirement to meet the FDA requirements for maintaining a Design History File (DHF), but not all ISO 13485 certified companies sell product in the USA.

Third, there is a new requirement related to protection of confidential health information, such as the information gathered during complaint investigations and clinical studies. Many companies refer to this as HIPAA compliance.

Updated Procedure & Webinar Bundle

If you need to update your control of records procedure and train your employees, you might consider our new procedure and webinar bundle.

Posted in: ISO 13485:201x, ISO Certification

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Color change is only device modification. Is a new 510k required?

This article explains the process for determining if a color change and other material changes require a new 510k prior to implementing the change.

color change Color change is only device modification. Is a new 510k required?

I recently taught a frequently asked questions (FAQs) webinar where I asked attendees to provide questions in advance of the webinar and I answered the questions during the webinar. One of the attendees asked how to know if a new 510k is required if the only modification to a device is a color change.

New FDA guidance for device modifications

On August 8, 2016 the FDA released a new draft guidance document for device manufacturers regarding device modifications and when a new 510k is required. The current final guidance is titled “Deciding when to submit a 510(k) for a change to an existing device,” and that guidance is dated January 10, 1997. A draft guidance document on this topic was released in several years ago, but that draft guidance was withdrawn in response to feedback from industry. The new draft guidance document includes modified decision trees to help manufacturers decide which types of changes will require a new submission, but there are also examples provided in Appendix A. The most helpful part of the guidance, however, is Appendix B. Appendix B explains how to document changes properly—regardless of whether a change requires a submission or not.

Decision Trees from the Guidance

There are five decision trees or flow charts provided in the new draft guidance. The purpose of each decision tree is identified below:

  • Main flow chart
  • Decision Tree A = labeling changes
  • Decision Tree B = technology, engineering and performance changes
  • Decision Tree C = material changes
  • Decision Tree D = IVD product changes

How to apply Decision Tree C to a color change

Typically adding a colorant, or changing a colorant, does not negatively impact strength of a device but this is the first cautionary statement made at the beginning of the section for material changes. Therefore, if your device has an performance testing requirements that involve a component that is involved in a proposed color change, then you need to repeat the performance testing to verify that the strength has not been negatively impacted by the color change. Sometimes large concentrations of colorant result in weakening of plastics. Therefore, repeating some of the performance testing or providing data that supports the need for no further testing is expected. In the decision tree this is addressed by question C5, “Could the change affect performance specifications?” If no, then you document the change but a new 510k is not required. If yes, then you refer to decision tree question B5.

The next concern addressed by Decision Tree C is the biocompatibility of your modified device. If the material change of the device or device component comes into direct contact with the body, blood or tissues then biocompatibility risks must be assessed. If the change does create new or increased issues related to biocompatibility then question C4.1 asks, “Has the manufacturer used the same material in a similar legally marketed device?” If the changed material has not been used previously for a similar application, then a new 510k is required—typically a Special 510k if only the material is changed and only biocompatibility needs to be assessed by the FDA.

Reference to FDA biocompatibility guidance

Within the guidance document, the FDA explains that you may want to refer to “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” when you are answering question C4. This new final guidance was released on June 16, 2016 and the Office of Device Evaluation (ODE) appears to be focusing much more closely on biocompatibility since this new guidance released.

Examples of material changes from FDA guidance

There are six examples of material changes presented in the new draft guidance:

  1. Slight change in polymer composition for a catheter = letter to file
  2. Change in polymer for a catheter
    1. Change in a polymer for a catheter to a polymer already used by another manufacturer for a 510k cleared device with the same indications = new 510k submission
    2. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type and duration of contact = letter to file
    3. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but shorter duration of contact = new 510k submission
    4. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but longer duration of contact = letter to file
  3. Change in manufacturing method of catheter tubing (i.e., molding to extrusion) = new 510k submission
  4. Change in material for a catheter
    1. New polymer is already used by your company for another 510k cleared catheter of the same type and same duration, but the sterilization method changes (i.e., gamma to EO) = new 510k submission
    2. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing (i.e., molding) and method of sterilization (i.e., EO) = letter to file
    3. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing and sterilization, but the performance specifications are slightly different = letter to file (depends upon impact of difference)
  5. Change in dental implant from untreated surface to acid-etched = new 510k submission (may also be considered a design change)
  6. Implantable device is marked temporarily with tape proven not to leave a residue = letter to file

Do you have other questions about biocompatibility?

On Thursday, December 1 @ 11:00am EST I will be hosting a new live webinar on the topic of biocompatibility. The webinar will address both requirements for 510k submissions and for CE Marking technical files. If you are interested in registering for that webinar, please click on the following link:

Click Here for Biocompatibility Webinar 300x64 Color change is only device modification. Is a new 510k required?

Do you have a question about your 510k submission?

If you have a question related to your 510k submission, you can submit your question to me and download the webinar recording for free by clicking on the following link:

Click Here for 510k FAQs Webinar 300x64 Color change is only device modification. Is a new 510k required?

 

I will respond your question by email, but most questions make great future blog topics—like this one.

You might also be interested in our 510k course series:

Click Here for 510k Course 300x64 Color change is only device modification. Is a new 510k required?

You gain unlimited access to 24 webinars related to 510k submission.

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Redacted 510k Database – Have you used the newest FDA tool?

This article describes the new database of redacted 510k submissions that was recently made available on-line for immediate download by the US FDA.

Number of Redacted 510k Available Since November 2000 Redacted 510k Database   Have you used the newest FDA tool?

Recently the FDA made redacted 510k submissions that were previously released through Freedom of Information Act (FOIA) requests available on-line for immediate download. There are 496 redacted 510k submissions available since November 2000–as indicated by the graph above. This is only a small fraction of the total number of 510k submissions, but the number that are available on-line will increase over time.

Types of redacted 510k Submissions

Of the 496 submissions there is a mixture of submission types.

  • 382 are traditional 510k submissions
  • 97 are special 510k submissions
  • 17 are abbreviated 510k submissions
  • 14 were 3rd Party reviewed

What remains in a redacted 510k submission

The redacted versions do not include testing data, but you will find other goodies such as:

  • 3rd Party SE memorandums (where applicable)
  • Table of Contents
  • Pre-market Notification Cover Sheet (i.e., FDA Form 3514)
  • 510k Cover Letter
  • Indications for Use (i.e., FDA Form 3881)
  • 510(k) Summary
  • Truthful & Accuracy Statement
  • Device Description
  • Executive Summary
  • Substantial Equivalence Discussion (Partially Redacted)
  • Summary of Biocompatibility Testing (Partially Redacted)
  • Summary of Sterilization & Shelf-Life (Partially Redacted)
  • Proposed Labeling
  • Predicate Device Labeling
  • Declarations of Conformity (i.e., FDA Form 3654)
  • Deficiency Letter

This is extremely valuable information that can be used to help select a potential predicate and to develop a verification and validation testing plan. If you are less experienced in the preparation of a 510k submission it will help to see how other regulatory experts have organized their own 510k submissions.

Learning more about redacted 510k submissions

In order to access this database, click on this link: Redacted FOIA 510k Database. In order to limit your search to only 510k submissions that are available as a redacted full 510k, just click on the box for “Redacted FOIA 510k.” If you are interested in learning more about how to make the most of this new resource, please sign up for my new webinar on Monday, November 21 @ 9am EST.

Posted in: 510(k)

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Abbreviated 510k or Traditional 510k, which should you choose?

This article briefly explains the three types of 510k submissions and identifies when you should be submitting an abbreviated 510k instead of a traditional 510k.

Abbreviated 510k Abbreviated 510k or Traditional 510k, which should you choose?Three types of 510k submissions

The FDA has three different target timelines for reviewing a 510k submission and issuing a decision regarding substantial equivalence (i.e., SE Letter):

  1. Special 510k
  2. Abbreviated 510k
  3. Traditional 510k

Special 510k submissions

The first type is a special 510k submission. The FDA target timeline for a special 510k is 30 days, but you can only submit a Special 510k for a modification of your own device that already has a 510k issued. In addition, a Special 510k is only possible if the device modification requires a single technical discipline to review the change. For example, changes to software and materials requires a review of software validation and biocompatibility. Therefore, two reviewer specialists must coordinate their efforts and the review cannot be completed in 30 days. In this case an abbreviated or traditional 510k must be submitted instead.

Abbreviated 510k submissions

The second type of 510k submission is an abbreviated 510k. The FDA target timeline for review is 60 days. If there is a recognized standard specific to the type of device you are submitting, or the FDA has issued a guidance document addressing that device classification, then an abbreviated 510k submission is recommended. For example, a dental handpiece (i.e., product code is ) has a special controls guidance document that written specifically for dental handpieces and the guidance states that an abbreviated 510k submission is recommended. In addition, the FDA recognizes the latest standard for dental handpieces: ISO 14457:2012 (FDA Doc # 4-206).

Traditional 510k submissions

The third type of 510k submission is a traditional 510k submission. The FDA target timeline for review is 90 days. If you are submitting a 510k for a new device, or the device modifications require more than one functional area of expertise, then a special 510k is not an option. If there is no recognized standard for the device type and the FDA has not issued a special controls guidance for your device classification, then an abbreviated submission is also not an option. A traditional 510k submission is your only option in this case.

How frequently is an abbreviated 510k submission type used?

In September 2016 there were 260 510k SE decisions issued by the FDA. Here’s the breakdown by type:

  • Special 510k – 47 submissions = 18%
  • Abbreviated 510k – 8 submissions = 3%
  • Traditional 510k – 205 submissions = 79%

In general, I think it requires a little more effort to write clear and concise summaries for the various sections of an abbreviated 510k than it does for a traditional 510k. But if you can get your product to market a month quicker then it’s worth it.

Posted in: 510(k)

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