FDA

Apr 30 2014

6 UDI Implementation Deadlines You Need to Remember

1 Comment / FDA / By Robert Packard / UDI, UDI Implementation, UDI Implementation deadlines, Unique Device Identifier

The first of the UDI implementation deadlines for the FDA’s Unique Device Identifier (UDI) Regulation is approaching fast. Do you know when your medical devices must be labeled with a UDI? Read on to find out.

FDA requires higher risk devices to be brought into compliance with the UDI regulations first. Compliance starts with Class III devices and devices licensed under the Public Health Service (PHS) Act (http://bit.ly/PHS-Act). Lower risk devices will follow.

1. June 23, 2014, is the compliance deadline for Class III and PHS Act device labelers to file a one-year extension. FDA requires extension requests be written (§801.55), documenting the number of labelers and devices subject to the request and explaining why an extension would be in the best interest of public health. FDA may also request additional information to help the Agency make a decision on this request. Federal Register – Class III Compliance Dates

2. September 24, 2014, is the first compliance deadline for labels and packages of Class III devices, Class III Stand-alone Software and devices licensed under the PHS Act to be “compliant.” These devices must have a UDI on its packages and labels, and human-readable dates must be formatted as YYYY-MM-DD (§801.18) and information submitted to the Global UDI Database (GUDID) (§830.300) by this date.

3. September 24, 2015, is the compliance deadline required for labels and packages of Implantable, Life-Sustaining, and Life Supporting Devices to have a UDI and corresponding data submitted to GUDID. Life-Sustaining and Life-Supporting devices are also required to have UDI as a permanent direct mark if they are to be used more than once and reprocessed before each use (§801.45). Stand-alone software that is life-sustaining or life-supporting must have a UDI per §801.50(b). Human readable dates on these labels must be formatted as YYYY-MM-DD.

4. September 24, 2016, is the compliance deadline required for Class II devices and Class II Stand-alone Software to be compliant. As with the device classes above, this means having the UDI on the device label and package (human-readable date in YYYY-MM-DD format) and data submitted to GUDID. Class III devices intended to be used more than once and reprocessed between uses must have their UDI permanently marked on the device by this date.

5. September 24, 2018, is the compliance deadline for Class I devices and Class I Stand-alone Software, as well as devices not classified into Class I, Class II, or Class III. This date requires devices to have a UDI on their labels and packages, and the human-readable dates on labels must be in YYYY-MM-DD format. Class II devices intended to be used more than once and reprocessed between uses must be directly marked with their UDI.

6. September 24, 2020, is the compliance deadline for Class I devices, and devices that have not been classified as Class I, II, or III intended to be used more than once and reprocessed between uses, must be directly marked with their UDI.

FDA’s UDI final rule will be phased in over time to ensure that labelers would have adequate time to build and test systems and create the infrastructure needed to implement the regulation’s many requirements. FDA believes a phased approach will spread the cost and burden of implementation over a number of years. This approach, according to the FDA, should promote “the efficient and effective implementation of the final rule.”

On-hand inventory labeled and packaged prior to the above deadlines has been extended a 3-year grace period in the Final Rule. This inventory does not need to be relabeled/repackaged with their UDI until three (3) years past the compliance date of their product Class compliance date. FDA considers consignment inventory to fall under this provision. This requires companies to track consignment inventory, ensuring it is used before the three-year grace period expiring. Any inventory – on-hand or consignment – remaining past the grace period will need to be relabeled and/or repackaged to be compliant. Federal Register – Existing Inventory

6 UDI Implementation Deadlines You Need to Remember Read More »

Apr 22 2014

What is UDI and Why It Matters

1 Comment / FDA / By Robert Packard / FDA Final Rule, UDI, Unique Device Identifier

In “What is UDI and Why It Matters,” the author reviews the fundamentals of UDI, the FDA’s Final Rule applications, and its global significance.

FDA’s Final Rule (Federal Register – UDI Definition) states a Unique Device Identifier (UDI) is a code that sufficiently identifies a medical device throughout its distribution and use. The UDI is comprised of a static component, a “Device Identifier” (DI), and a dynamic component, a “Production Identifier” (PI).

The DI itself is made up of your Labeler Identification Code and a code that pinpoints the specific version or model of that device. PI, on the other hand, includes manufacturing information for that particular device, such as lot or batch number, serial number, expiration date, or manufacturing date (both in YYYY-MM-DD format).

Human cells, tissues, or cellular or tissue-based products (HCT/P) regulated as a medical device requires the use of the ISBT-128 format UDI. The UDI Final rule requires medical device labels to contain a UDI unless exempt or provides for an exception or alternative placement. The UDI must be both human-readable and in a form that uses automatic identification and data capture (AIDC) technology.

Reprocessed and Single-Use Devices

Medical devices used more than once and reprocessed by intention must have the UDI directly marked on the device. The Final Rule details exceptions to this requirement (Federal Register – Direct Marking Requirement). UDI does not need to be on individual single-use devices. Instead, it needs to be located on the next higher package. For example, non-sterile exam gloves would require a UDI on the box label, not each glove.

This section of the rule stipulates individual single-use devices, all of which are the same version or model, must be distributed together in a single device package, are intended to be stored in that device packaging until removed for use, and are not intended for individual sale. However, it does not apply to implanted devices, which require a UDI on the package of the individual device. Federal Register – Single-use Device

Stand-Alone Software

Stand-alone software that is regulated as a medical device must also bear a UDI. The software version should be included in the production identifier. If the software is downloaded from a website, the UDI must be in plain text (i.e., not in AIDC format) and displayed whenever the software is started and/or in the plain text displayed through a menu command, such as the “About” screen. If Stand-Alone Software is sold in a package, the package must have the UDI on its label. However, the DI of packaged software may be identical to the downloaded version. Federal Register – Stand-Alone Software

Why Now? Why Does It Matter?

Some medical device companies, especially distributors, obscure manufacturers’ names and item codes on device labels. Different devices might have the same item code, while the same device might have different item codes. These inconsistencies confuse healthcare professionals—especially during recalls and adverse event reporting. Therefore, FDA and other regulatory agencies are implementing UDI regulations to:

Improve patient safety by reducing medical errors.
Strengthen the Electronic Medical Records initiative by providing a standard method for recording each device’s identity during use in clinical information systems, claim data sources, and registries.
Address counterfeiting and diversion.
Prepare for medical emergencies and disasters.
Provide a foundation for a global, secure distribution chain.

The most crucial reason for UDI regulations is the need to improve the accuracy and timeliness of Post-Market Surveillance (PMS) data. More accurate and timely PMS data will indirectly enhance patient safety by helping facilitate more accurate reporting, reviewing, and analyzing adverse event reports so problem devices can be pinpointed, corrected, and removed faster.

Impact of UDI Regulations Globally

FDA hopes the UDI regulations will lead to the development of a globally harmonized medical device identification system that is recognized worldwide. The European Union and regulatory agencies around the globe are drafting their versions of a UDI regulation. In addition to the benefits of implementing a UDI system in general, a global UDI system would:

Allow companies to create globally harmonized labeling with a single UDI worldwide.
Promote worldwide tracking and tracing of devices for easier recalls
Provide another risk control to prevent counterfeiting and diversion of medical devices

To that extent, the International Medical Device Regulators Forum (IMDRF) published their UDI Guidance document IMDRF UDI Guidance Document, which has many similarities to the FDA Final Rule.

The Unique Device Identifier Final Rule is more than just a new FDA regulation—it is also good business practice. Healthcare customers are embracing the use of unique identifiers. In past experiences with implementing GTINs (another form of UDI from the UDI issuing agency GS1), customers demanded implementation of GTINs, or they would find a new supplier. Manufacturers may choose to ignore one or two customers. Still, eventually, the number of customers demanding UDI will be significant, and they will need to act quickly—regardless of FDA deadlines.

What is UDI and Why It Matters Read More »

Apr 17 2014

Medical Device Regulation: FDA Pilot Programs for Global Harmonization

3 Comments / FDA / By Robert Packard / FDA pilot programs, global harmonization, medical device regulation

This blog provides an overview of global harmonization efforts by the FDA that were implemented for medical device regulation.

Harmonization of international regulatory requirements for medical devices began in 1992 with the founding of the Global Harmonization Task Force (GHTF). There were five founding regulatory bodies: 1) US FDA, 2) Health Canada, 3) European Commission, 4) Therapeutics Goods Administration of Australia, and 5) Ministry of Health, Labour and Welfare in Japan. The organization created many guidance documents for the medical device industry, and members of the GHTF organization also participated in the development of ISO 13485 that was released in 1996. GHTF was disbanded in late 2012, and it has been replaced by the International Medical Device Regulators Forum (IMDRF), and IMDRF maintains the documentation created by GHTF.

In 1996, when ISO 13485 was released, Health Canada made certification to ISO 13485 mandatory for all medical device manufacturers that wanted to distribute in Canada. Health Canada’s requirement for ISO 13485 certification resulted in the widespread adoption of ISO 13485 certification throughout the world. At the same time, the US FDA chose to publish its Quality System Regulations. The QSR is very similar to ISO 13485, but there are minor differences beyond the obvious reorganization of the requirements.

FDA Modernization Act of 1997

Under the FDA Modernization Act of 1997, the FDA implemented a 3rd party review program for 510(k) reviews and inspections. This program involves “Accredited Persons” (AP) that have been trained by the FDA and work for a third-party consulting firm, registrar, or Notified Body. The FDA expanded the pilot program for third-party 510(k) reviews to include most 510(K) devices. Unfortunately, even though there was great interest from third-parties to participate in the program, there was little interest from manufacturers. After more than a decade, only the following seven third-party organizations have managed to get an Accredited Person (AP) to complete the qualification process so that they can perform inspections independently:

BSI
LNE/G-MED
CMS/ITRI
Orion Registrar
SGS
TUV SUD
TUV Rheinland

The FDA continues to experiment with different approaches to international harmonization. In 2003, Health Canada (HC) signed a memorandum of understanding between Health Canada (HC) and the U.S. In 2006, the FDA launched the pilot, Multi-purpose Audit Program (pMAP). Third-party auditors performed ten combined audits. The conclusions and recommendations resulting from the pMAP were posted on the FDA website in 2010. One of the recommendations was to develop a guidance document for the format and content of regulatory reports. Therefore, in 2011, GD211 was released by HC, and several videos were posted on the FDA website by HC and the US FDA CDRH Learn webpage for training.

Once the 14 recognized registrars had managed to train their CMDCAS auditors on the GD211 report format, the FDA announced the Voluntary Audit Report Submission Pilot Program. For eligible companies, they may submit a regulatory report in the GD211 format, and the FDA will remove the manufacturer from the routine workload for FDA inspections. A few companies have taken advantage of this and successfully avoided a routine inspection for 12 months.

FDA’s New Pilot Program

Recently, the FDA announced a new Voluntary Compliance Improvement Program Pilot. This new program is a small pilot that will allow 3-5 manufacturers to select a third party (to be approved by the FDA) to help them identify areas for compliance improvement and initiate corrective actions. Identification of areas for improvement would presumably be determined during a mock-FDA inspection performed by the third party, but this is not explained in the FDA announcement. This program is available by invitation only, but it appears to be a significant departure from the AP program and voluntary submission of GD211 audit reports.

IMDRF is finally starting to have an impact on the harmonization of medical device inspections. In January 2014, the FDA began accepting inspection reports from the Medical Device Single-Audit Program Pilot (MDSAP) as a substitute for routine agency reports. Kim Trautman at the FDA is the IMDRF representative chairing the program, and her presentation announcing the program can be downloaded. This program should be extremely popular with manufacturers because the MDSAP reports can also be used to meet requirements for inspections by Japan’s MHLW and Brazil’s ANVISA. ANVISA has a massive backlog of inspections due to a strike by government workers, and many companies were forced to file a lawsuit against ANVISA to accelerate the inspection prioritization. The challenge with the MDSAP will be to train and qualify third parties to conduct the audits correctly.

Medical Device Regulation: FDA Pilot Programs for Global Harmonization Read More »

Apr 11 2014

Unique Device Identifier Final Rule-FAQs-Part II

1 Comment / FDA / By Robert Packard / UDI, Unique Device Identifier, Unique Device Identifier (UDI) Final Rule, Unique Device Identifier FAQs

Unique Device Identifier Final Rule-FAQs-Part II. What is there to look forward to?

September 24, 2014, is the first UDI DEADLINE for Class III devices, Stand-Alone Software, and devices licensed under the PHS Act.

Who is an Issuing Agency?

FDA has accredited three (3) agencies for the operation of a system to issue unique device identifiers. They are GS1 (www.gs1.org), the Health Industry Business Communications Council (HIBCC) (www.hibcc.org), and the International Council for Commonality in Blood Bank Automation (ICCBBA) (www.iccbba.org). GS1 and HIBCC are for medical devices, while ICCBBA is for medical products of human origin that are regulated as medical devices.

We sell single-use devices; do we need to label these products?

A UDI does not need to be placed on each single-use device (i.e., primary packaging). Instead, the UDI is to be placed on the secondary packaging (e.g., outer box). For example, exam gloves. The UDI label goes on the box, not each glove. This rule requires the package:

Have a single version or model
Be distributed together in a single device package
Are intended to be stored in that device packaging and
Are not intended for individual sale

Placement of the UDI on the secondary packaging for single-use devices does not apply to implanted devices. While implants are technically “single-use” devices, implants (defined as devices placed in the body for 30 days or longer) must have a UDI on the primary packaging. Federal Register – Single-use Devices

I understand there are implementation deadlines; what are they?

There are several deadlines related to this new regulation based on device Class. For example, Class III devices, Stand-Alone Software, and devices licensed under the PHS Act must be “compliant” and have a UDI on their package label, and information must be submitted to the Global UDI Database (GUDID) by September 24, 2014. There is an opportunity to file for a 1-year extension for these classes of devices under §801.55. The deadline for filing this extension is June 23, 2014.

Other implementation deadlines are (includes submitting data to GUDID):

September 24, 2015, Implantable, Life-Sustaining & Life Supporting Devices

September 24, 2016, Class II devices and Stand-Alone Software

Class III devices intended to be used more than once and reprocessed between uses must be directly marked with UDI.

September 24, 2018 Class I devices and Stand-Alone Software

Devices not classified into Class I, II, or III

Class II devices intended to be used more than once and reprocessed between uses must be directly marked with UDI.

September 24, 2020 Class I devices and those not classified as Class I, II, or III, intended to be used more than once and reprocessed between uses, must be directly marked with UDI.

On-hand inventory labeled before the deadline does not need to be relabeled with a UDI for up to three (3) years past the deadline. FDA considers consignment inventory to fall under this rule. This requires that you track consignment inventory, as well as ensure the inventory is used before this three-year exception expiring. Federal Register – Implementation Dates

Our device is packaged one unit per package; do we need to label the device itself?

This is a “unit of use” issue. If you sell ten individually packaged devices ONLY in an outer pack, the individual devices do not require a UDI. Generally, labeling the outer pack with the UDI is sufficient. This assumes the device is stored and used that way.

I heard the information on our devices needs to be submitted to a “database.” Please explain.

UDI has been implemented to facilitate postmarket surveillance activities, including identifying medical devices through their distribution and use. FDA believed a significant part of this was the ability for healthcare professionals and users to “search” a database to locate information about devices. This resulted in the creation of the Global Unique Device Identification Database (GUDID) system, which is a repository for 60-plus attributes for each Device Identifier and its corresponding Labeler information. Federal Register – GUDID Information

How do we submit data to the Global UDI Database?

There are two standard-based methods to submit data to the Global UDI Database (GUDID) – structured input via an FDA web interface or using the Health Level 7 Structured Product Labeling (HL7 SPL) process. HL7 SPL is in XML format and uses the FDA electronic submission gateway as the pathway to input data into GUDID. To submit data to GUDID, you must first request a GUDID user account from the FDA. Data is submitted one record at a time for both methods. There is no batch process. Federal Register – GUDID Submission

What additional information needs to be printed on a label under this new rule?

Medical devices must also follow labeling requirements detailed in Title 21, Subchapter H, §801, and the new requirements per the UDI rule. Required information printed on the labels is also dictated by other regulatory agencies, such as the EU. Specifically, the UDI regulation requires a UDI to be printed in easy-to-read plain text and an Automatic Identification and Data Capture (AIDC) format and placed on the device label. The AIDC format is dictated by the format of the issuing agency you have chosen. The other label element FDA requires is the date format when a date is used on a label. The date format is YYYY-MM-DD, and a day must always be used. Federal Register – UDI Format

When do I need a new Device Identifier?

A new UDI is required when there is a change to a version or model. If you call the device a new version or model, and the users think the same, it is a new device and requires a new Device Identifier (DI) and label changes. If the number of units in a device package changes – for instance, going from 5 to 10, then a new DI is required. This aspect often confuses people, as they think it has to do with changes in package artwork. Federal Register – New UDIs

Need More Information on how to design and implement a compliance plan for the Unique Device Identifier Rule?

FDA UDI Regulation on Medical Device Labelers is a complimentary webinar and PowerPoint training. To access – CLICK HERE

Unique Device Identifier Final Rule-FAQs-Part II Read More »

Apr 4 2014

Unique Device Identifier Final Rule-FAQs-Part I

1 Comment / FDA / By Robert Packard / UDI, Unique Device Identification (UDI), Unique Device Identifier, Unique Device Identifier (UDI) Final Rule, Unique Device Identifier (UDI) Final Rule-Part 1, Unique Device Identifier FAQs

This blog, “Unique Device Identifier Final Rule-FAQs-Part 1,” answers questions, such as, what is a UDI? Who is responsible for applying the UDI label? Etc.

What is a “UDI?”

The Unique Device Identifier (UDI) adequately identifies a device throughout the supply chain and while in use. It is constructed of two main sections – a device identifier and a production identifier. The device identifier is comprised of a permanently assigned product code (model or version) and a labeler identification code. The production identifier is a dynamic component and made up of a lot number, serial number, manufacturing date, expiration date, etc. The device identifier and production identifier together make up the UDI. Federal Register – Unique Device Identifier definition

Who is responsible for applying the UDI label?

FDA has defined the “Labeler” to be the entity responsible for applying the UDI label. This entity may or may not be the actual manufacturer. The Labeler is defined as the entity that causes a label to be secured to a device and who places the device into commercial distribution with the expectation the label will not be replaced or modified in any way. Additionally, should an entity replace or substantially modify the original label, and then place the device into commercial distribution with the expectation the label will not be replaced or modified in any way is also a Labeler. Distributors who simply add their name and address to the package are not defined as a Labeler under this definition.

Private label devices present a situation where the actual manufacturer or brand name holder can be the Labeler. This would be a business decision between the manufacturer and the brand name holder. The Labeler may also be the specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. Federal Register – Labeler definition

What does a “standardized” date format mean?

FDA has decided for all human-readable dates (manufacturing date, expiration date, etc.) printed on labels must follow a YYYY-MM-DD format. The DAY is an absolute requirement. For example, March 31, 2014, must be presented as 2014-03-31. This requirement applies to ALL medical device classes that use a date on their label. Federal Register – Date format definition

I have kits that are comprised of several devices; how does this rule apply to me?

There are many types of kits. Kits can be made up of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to expedite a single surgical or medical procedure. §801.30(a)(11) states when a device is packaged within the “immediate container of a combination product or convenience kit, the label of the device will not be required to bear a UDI,” as long as the label on the kit has a UDI. Should your kit have a National Drug Code (NDC) number on its label, it does not also need to have a UDI. §801.30(b)(3) clearly states devices that are included in a combination product with an NDC number on its label and does not have a UDI; the device components must bear a UDI on its label. Federal Register – Kits Exemption

What does reprocessing mean?

FDA uses the term “reprocessing” in conjunction with a direct marking of a unique device identifier. Devices intended to be used more than once must have the UDI permanently marked directly on the device (with a few exceptions), and will be reprocessed between each use. However, the FDA has not yet defined what “reprocessing” means. I have asked FDA this question, with their response being they will “shortly” issue additional guidance on this matter. When they do, I will let you know via this blog. Until they do, use the following definition of “reprocessing” – clean, clean plus disinfected, or clean plus sterilized. Federal Register – Direct Marking and Device Reprocessing

We sell software that is considered a medical device; how do I label these devices?

Stand-Alone Software (SAS) regulated as a medical device must also have a UDI. SAS that is downloaded from the web and/or sold packaged must use the version number (as the lot number) in its production identifier. The full version of the UDI must be displayed in easy-to-read plain text, following the rules of the issuing agency you have selected, on the start-up screen and/or a menu command screen, such as the “About” screen. The UDI on the SAS packaged form may have the same device identifier. Federal Register – Stand-Alone Software

What is a device package?

A device package is a package that contains a fixed number of a specific version or model of a device. The use of this term has often confused people who think it has something to do with the package design. Federal Register – Device Package definition

Do I need to label our shipping containers?

A shipping container, for this regulation, is defined as a container used to ship or transport devices in which the items within may change from one shipment to another. The rule does not require a UDI label for any shipping container. Federal Register – Shipping Container

Unique Device Identifier Final Rule-FAQs-Part I Read More »

Feb 3 2014

Data Analysis of Medical Device FDA Form 483s Issued in FY2013

4 Comments / FDA / By Robert Packard / 2013 FDA 483s, medical device FDA 483s, medical device FDA 483s issued in 2013, Medical device FDA regulatory compliance

The author performed data analysis of medical device FDA Form 483s issued in FY2013. Was Design Controls, CAPA, or complaint handling the number one 483?

The FDA recently updated its webpage for “Inspections, Compliance, Enforcement, and Criminal Investigations” (http://bit.ly/FDA483s). The update was the addition of FY2013’s inspection observations (i.e., 483s). Medical Device Academy performed data analysis of the inspection observations report for FY2013. The high frequency of FDA Form 483s referencing CAPA and complaint handling was not a surprise, but the results of the Pareto analysis (http://bit.ly/ParetoChart) might surprise you.

Data without Categories Data Analysis of Medical Device FDA Form 483s Issued in FY2013 — Ranking of Individual Observation References

If you sort the raw data from the FDA, instead of categorizing the observations first, you see that 21 CFR 820.100(a) (i.e., the CAPA procedure requirement) is the most frequently referenced section. Complaint handling, 21 CFR 820.198(a), is the second most frequently referenced section. CAPA even gets the third spot on the table to the left, while the highest-ranking of an individual section for design controls [i.e., 21 CFR 820.30(i)] is eighth. The problem with this approach is that there are 244 sections to review, and it’s challenging to identify which process areas to focus on. Therefore, Medical Device Academy first categorized the data by section and then sorted the data.

The section of the CFR referenced categorized the data from FY2013. For example, there are 15 sub-sections related to section 21 CFR 820.198. Therefore, all 15 were grouped under one category. The data categorization allowed us to reduce the number of observation references from 244 to 32. By doing this, it was clear that CAPA (11.75%) and complaint handling (10.65%) are more frequently referenced in FDA Form 483s than the next most frequent section—medical device reporting (6.24%). However, categorizing the data first shows that design controls (21 CFR 820.30) were referenced more frequently than any other category in FY2013.

You may also expect to see a large percentage of Form 483 observations issued against management responsibilities. However, section 820.20 (i.e., management responsibilities) ranks 13^th out of 32 categories (4.05% in the table below). We even considered that maybe FDA inspectors were issuing fewer 483s against section 820.20 in FY2013 than in previous years. However, FY2012 also had slightly more than 4% of the FDA Form 483s issued against this category.

The frequency of 13.25% for design controls may surprise you. However, when all 15 of the different observation references for design controls are combined into one category, there is a total of 582 observations. For comparison, only 12.68% of the FDA’s 483 observations were related to design controls in FY2012. Therefore, inadequate implementation of design controls (Implementing820-30) remains the most frequently referenced observation.

If you want to download the Excel spreadsheet we used to create the above chart and graph, please follow this link: http://bit.ly/Download-Pareto483s.

Preventive Actions

The Pareto analysis can also be used to focus your internal auditors or a mock FDA inspection. For example, your next audit might start with a review of the CAPA process since that is the second most frequent observation reference by FDA inspectors (CAPAMistakes). Next, you may want to audit complaint records and medical device reporting (outsourcing complaints). These are the third and fourth most frequent observation references. Finally, after you have finished these three areas, you should select a product line that has not been recently inspected by the FDA and perform an audit of the Design History File (DHF): AuditDesign. The auditor should verify that all changes to the Device Master Record (DMR) have been documented and validated per your Design Controls procedure.

In addition to performing a mock FDA inspection, you should also invest in training of employees in each of the four most critical areas:

Design Controls
CAPA
Complaint Handling
MDRs

Signing a training record to indicate that you read and understood a procedure does not meet the requirements for training personnel. You need to develop a training curriculum for each subject area with practical examples—not just bullet points copied from the QSR. In addition to reading and sharing the blogs referenced for each of the above areas, you might also consider reviewing the following blog about training effectiveness: TrainingExams.

If you are interested in training courses, Medical Device Academy has a library of pre-recorded webinars available: QA-RA-Webinars. We also have exams that can be used to verify training effectiveness after each webinar. Please let us know if you want something specific because we develop new customized training webinars monthly.

Data Analysis of Medical Device FDA Form 483s Issued in FY2013 Read More »

Jan 22 2014

4 Ways to Create Your FDA Medical Device Regulatory Updates

Leave a Comment / FDA / By Robert Packard / Creating your own FDA medical device regulatory updates, FDA medical device regulatory compliance, FDA medical device regulatory updates, medical device consultant, medical device consulting, medical device regulatory

Although FDA medical device regulations are centrally located in one place, the FDA homepage, this blog discusses four information areas you can monitor to create your own FDA medical device regulatory updates.

Guidance documents released (FDA-guidance),
Recognized standards (Recognized-Consensus-Standards),
Device classifications (Product Classification), and
Total Product Lifecycle (TPLC) database (FDA-TPLC).

Guidance Documents

When you check the FDA website for the new draft and final guidance documents, the webpage to monitor is http://bit.ly/newFDAguidance. This page had already had four new guidance documents in 2014, and in October 2013, the FDA released an important update about the eCopy program for 510(k) submissions: FDA-eCopy.

Recognized Standards

The FDA has a separate database for all recognized consensus standards: Recognized-Consensus-Standards. This database is used to verify which Standards can be used for verification and validation testing of new devices, and the reference of any of these Standards in a device submission must also be accompanied by the completion of Form FDA 3654: http://bit.ly/Form-FDA-3654.

Device Classifications

Changes to device classifications and/or regulatory approval pathways are rare at the FDA, but you should periodically check the classification database to verify that there have been no changes. The most likely changes will be the addition or removal of recognized standards applicable to your devices. The database for looking up device classifications can be found at Product Classification.

TPLC Database

For each 3-letter product classification code, there is a database that shows all the recent 510(k) submissions and recalls and summarizes all the medical device reports submitted for severe injuries and deaths. This database, FDA-TPLC, should be monitored to proactively identify problems that occurred with similar products before they happened to your product. Also, there may be voluntary reports from user facilities regarding your device that were not reported directly to your company. The possibility of voluntary reports makes this a vital database to monitor weekly. Other resources include:

CDRH-news-updates – This is the page of the device division of the FDA (CDRH), where news and updates are posted. You may find it helpful to register for receiving the RSS feeds from this page so that you are informed of any updates as FDA posts them.
CDRH-Learn – This is the page where CDRH lists all the online training courses for medical device manufacturers. This includes popular courses such as the “Pre-market Notification Process – 510(k)s” and “Medical Device Recalls.” This page also had four recent updates: 1) “Investigation Device Exemption Process – IDE,” updated on December 6, 2013; 2) “Device Establishment Registration and Listing,” updated on July 31, 2013; 3) “Global Initiatives,” updated on October 31, 2013; and 4) “Unique Device Identification (UDI) System,” updated on December 23, 2013.

Next Steps

Review each of the above streams of information from the US FDA on a scheduled basis as preparation for quarterly management reviews and determine any potential impact on your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

Initiate specific changes to existing procedures.
Create new procedures or
Initiate a quality plan for more substantial changes to your quality system.

Management Review-Free Webinar Recording

If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review slide deck, as well.

4 Ways to Create Your FDA Medical Device Regulatory Updates Read More »

Sep 25 2013

8 success tips for the first 30 minutes of an FDA inspection

1 Comment / FDA / By Robert Packard / FDA, FDA inspection

Here is an 8-item action plan and discussion for getting your FDA inspection off to a good start, beginning when the FDA enters your facility. When an FDA inspector arrives at the reception desk of your facility, the last thing you want is a Keystone Kops scenario with people running around in a panic and keeping the inspector waiting. This is your first opportunity to make a professional impression, and you never want to give an inspector the impression that you have something to hide. What happens during the first 30 minutes of arrival is critical. While medical device inspections are often announced several days in advance, the Agency is not obligated to do so. Therefore, your team needs training and a plan. This training should involve more than just reading the Quality System Inspection Technique (QSIT) manual (http://bit.ly/QSITManual) and conducting a mock FDA inspection. Last year, Rob Packard wrote a blog about “10 FDA Inspection Strategies that Don’t Work” (https://medicaldeviceacademy.com/fda-inspection-strategies-that-dont-work/), but the following activities need to be executed in the first 30 minutes to ensure your next inspection starts smoothly.

The FDA Inspection: 8 Immediate Actions to Take

1. Receptionist-Personnel Contacts (Time Zero)

I once witnessed a receptionist sarcastically comment to an inspector that people must be thrilled when they walk in the door. That was not a great start to the inspection. Ensure that your receptionist and additional personnel who may sit at the desk are trained, understand what to do, and know how to behave when an FDA inspector(s) arrives. This exercise should not cause panic. You need a simple work instruction located at the reception desk and a list of key staff members to contact immediately. The head of the Quality department, or Management Representative, is usually the first call.

2. Have a Chain of Command in Place (Time = 1 minute)

DO NOT keep the inspector waiting in the lobby. Have a communication chain in place to ensure that other appropriate personnel are available if the first point of contact cannot be reached. It is reasonable to ask the inspector to return later ONLY if all individuals with the technical expertise to participate in the inspection are not on-site or are out of the country. The agent will decide whether to honor this request, but the expectation is that there is always someone with whom they can work with. Never make this request to put off the inevitable.

3. Ask To See Inspector Credentials (Time = 2 minutes)

Ask to see the inspector’s credentials, and ensure you give them more than a cursory glance. This is important to avoid allowing an imposter posing as an Agency employee from gaining access to your business. While a rare occurrence, it has been known to happen. Some investigators are officers of the Public Health Service and may be in uniform. However, even these officers are not required to wear a uniform for all visits. Note: Section 5.1.1.2 of the FDA Investigations Operations Manual (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual) instructs inspectors to provide their credentials to top management, but copying of official credentials is not allowed.

4. Escort Inspector to Inspection Room (Time = 5 minutes)

Ensure you can escort the inspector to a suitable room with the respective hosts within five minutes of arrival. This will involve ensuring that all administrative staff and critical management clearly understand that any other meeting may need to be curtailed or moved immediately to another location to provide an appropriate space for the inspection. Providing substandard accommodations, such as a very cold or warm room, is not a good strategy for shortening the inspection time. It is a ploy easily recognized by the Agency, though not appreciated. Note: Rob Packard taught an audio seminar earlier this year, where the use of inspection war rooms was covered in more detail—including a diagram with a proposed layout for the room.

5. Ready the FDA Inspection War Room (Time = 10 minutes)

Immediately after your inspection room is identified, you must prepare your backroom or “war room.” This room should be located near the inspection room and set up immediately with staff who can expertly execute their respective roles. You will need a mode of communication between the inspection and war rooms, runners to retrieve documents and records in the shortest time possible, and a technical individual to review these documents to ensure that they are appropriate and accurate before being provided to the inspector. This room should be ready within ten minutes of arrival.

6. Ensure You Have Emergency Supplies & Copies (Time = 15 minutes)

Your war room will need supplies. You should have a mobile cart equipped with inspection supplies ready and waiting at all times. Suggestions for the contents of your war room cart include a laptop, projector, staplers, staples, pens, blank folders, a label maker, and a stamp for “uncontrolled copies.” Your supplies must arrive at the war room within 15 minutes of arrival.

7. Ready the Frequently Requested Documents (Time = 25 minutes)

Don’t wait for the inspector to tell you which documents are invariably requested at the outset of any inspection. This includes but is not limited to, the organizational chart, an index of all procedures, a CAPA log, and your nonconformance logs for medical devices—all dating back to the last inspection. This doesn’t mean that you should offer these documents to the inspector. You want to prepare these before they are requested so that they can be provided quickly, but you should keep the copies in the war room until the inspector requests each document and record. Copies of these records and documents should be stamped and ready within 25 minutes of arrival.

8. Relax (Time = 30 minutes)

It sounds as though this process is a race against time. It is not. No one engaging with the inspector should be running in and out of the room, gasping for breath, or sweating profusely from the effort. Keeping the inspector waiting can be perceived as a stall tactic, perhaps arousing suspicion that you are creating records “on the fly” in the war room (definitely not a strategy that I recommend) or that you are having difficulty locating the requested documents, and are not in control of your Quality Management System (QMS). The most important aspect is to manage your QMS so that you are always ready for an inspection at a moment’s notice. If you prepare in advance, you shouldn’t need to do anything more than ask if the inspector would like coffee before the inspection begins.

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Aug 15 2013

How to Utilize CAPA Training To Avoid FDA 483 Citations

1 Comment / CAPA, FDA / By Robert Packard / CAPA, CAPA training, FDA 483

The author discusses how formal CAPA training can help solve the four most common CAPA deficiencies and help avoid FDA 483 citations.

Corrective And Preventive Action (CAPA) is considered one of the most critical processes in a Quality Management System (QMS). CAPAs prevent nonconformities from recurring and identify potential problems that may occur within the QMS.

Both the Code of Federal Regulations (21 CFR 820.100) and the ISO 13485 Standard (8.5.2 and 8.5.3, respectively) include similar requirements for establishing and maintaining a compliant CAPA process. The concept seems pretty straightforward, right?

Then why do so many companies struggle with this process and go into panic mode during FDA inspections and Notified Body audits?

CAPA process deficiencies have long been the number one Good Manufacturing Practice (GMP) violation cited in FDA Warning Letters. Therefore, providing trained experts to teach the CAPA process is well worth the investment to provide your employees with the expertise needed to implement a sustainable, effective, and compliant process. Support from top management is a must for success.

7 Reasons Why There is LIttle Support for the CAPA Process

Managers view CAPA as a necessary evil and apply minimum effort and resources to complete the required paperwork.
All complaints, audit findings, shop floor nonconformities, etc., go straight into the CAPA system, resulting in what is known as “Death by CAPA.” There are hundreds of CAPAs to be dealt with, but the CAPAs languish and quickly become a mountain of overdue records.
The lack of ability to conduct effective root cause analysis results in, at best, a band-aid solution and recurrence of the same issues time and again.
There is no risk-based or prioritization process that provides a triage for determining when a CAPA is appropriate and how to classify its criticality.
CAPA forms are either too restrictive, such as using “yes/no” questions, thereby stemming the creative flow of process thinking, or too open-ended, leaving the CAPA owner with little guidance for getting to the exact root cause.
Trending and metrics that would highlight quality issues before they become complaints are lacking, so most CAPAs are last-minute reactions to a crisis instead of proactive improvement projects.
Senior management has not allocated sufficient time and resources to CAPA owners to develop expertise and clearly does not understand the nuances of FDA compliance, the ISO Standard, and the responsibilities of CAPA ownership.

Consequences of an Ineffective CAPA System: FDA 483 Citations Are Possible

FDA 483 observations, Warning Letters, and loss of your ISO 13485 certification are possible consequences of failing to manage your CAPA process. Imagine explaining to your customers why you lost your certification and why they should keep you as a trusted supplier. That is not a conversation you want to have.

A weak CAPA process allows nonconformities to recur, results in manufacturing downtime, requires rework, and ends with the scrapping of products or lost customers. The consequences of a weak CAPA process negatively impact your company’s financial strategy and goals.

To prevent an increase in the cost of poor quality, your business cannot remain static. You need to improve and adopt best practices. Your CAPA process is a systematic way to make those improvements happen.

Characteristics of an Effective CAPA system?

Easy to follow the procedure
Defined CAPA inputs
Risk assessment and prioritization
Root-cause investigation tools
A well-defined action plan
Metrics to track progress
Communication of information and status
Effectiveness checks
Management support and escalation

What to Expect from Formal CAPA Training

Death by PowerPoint is not training. Effective CAPA training requires hands-on participation in working through root-cause analysis with an expert. One of the best training tools is case studies based on 483 recent observations. A CAPA training course should teach you how to:

Accurately identify the cause of problems
Prioritize your corrective and preventive actions using a risk-based approach
Implement an appropriate corrective and/or preventive action and
Verify the effectiveness of your actions

CAPA training should teach you how to reduce the length and number of investigations. Training will also help you master problem-solving methodologies to identify true root causes, utilizing facts instead of guesswork or opinion. The proper identification of the exact root cause of a problem is critical because otherwise, your CAPA plan will fail to fix real problems.

Not all formal training needs to be in person. Face-to-face training can be supplemented with more cost-effective training of concepts using webinars and recorded presentations. Interactive training is needed to supplement this training so students can practice what they learn.

How Training Solves Common CAPA Deficiencies

The four most common CAPA deficiencies are:

Inadequate procedures
Incomplete investigations
Overdue actions, and
Failure to perform an effectiveness check

Each of these deficiencies is addressed directly by CAPA training. Formal CAPA training reviews each of the requirements for your CAPA process, and trainers will often share samples of CAPA procedures and CAPA forms that they wrote and found to be effective. Learning multiple root cause investigation techniques and practicing them using the case study technique ensures that CAPAs are thoroughly investigated rather than identifying superficial symptoms.

CAPA metrics are introduced during training to ensure that the CAPA process owner knows best practices for monitoring and analyzing the process. Finally, CAPA training includes specific examples of what is and is not, a proper technique for performing an effectiveness check.

Results After Formal CAPA Training

The best reason for making formal CAPA training available to those responsible for CAPAs are the results you will experience after the training. For example:

Elimination of hundreds of overdue CAPAs
Reduction in nonconformities, scrap, rework, and customer complaints
Lower overall costs associated with quality problems
Better FDA inspection and Notified Body outcomes, and
Safer products for your customer

If you want to learn more about CAPA, click here to register for Medical Device Academy’s Risk-Based CAPA webinar.

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Sep 11 2012

How to request FDA Device Classification – 513(g) Alternative

1 Comment / FDA / By Robert Packard / Device Classification, FDA

This blog provides a five-step process on how to request FDA device classification information. A screenshot of the FDA website for each step is included.

If your company is currently registering with the US FDA, you are probably reviewing the guidance document this month for the FY2013 user fees. On pages six and seven, there is a table of these fees, but you might have overlooked 513(g). Section 513(g) is a provision in the law that allows companies to request device classification information from the FDA.

For example, if your company was developing a new product, and you were having difficulty identifying the regulatory pathway, 513(g) is your friend. In my opinion, these fees are modest: $5,061 = Standard Fee, and $2,530 = Small Business Fee (updated for FY 2022). Most consultants will charge at least ten hours of consulting to identify the regulatory pathway for a company. I would charge quite a bit less because it takes me a lot less than ten hours. I still think the FDA’s pricing is a good deal because getting information directly from the source is always more valuable than an “expert.”

The US FDA has published a guidance document explaining the process for 513(g) requests. This guidance document was released on April 6, 2012 (updated in 2019). The guidance explains what information companies need to provide in order to submit a 513(g) request. The guidance also has a fantastic list of FDA resources on page five. These are the very same resources that the “experts” use—including yours truly. If you absolutely don’t want to submit a 513(g), and you plan to search for you own predicate, we have another related article that provides five alternatives to a 513(g) for identifying a predicate device.

Just as any good lawyer tries to avoid asking questions that they don’t already know the answer to, I recommend that you first try using these resources yourself. Once you think you know the answer, your request for classification information will be easier to organize.

Here’s how I would proceed to request FDA device classification information:

Step 1 – Are there similar devices on the market?

Identify another device similar to yours. If you can’t do this, you need serious help. You need a similar device that is already sold on the market to use as a predicate device. If you cannot identify a predicate, then you can’t use the 510(k) process—or you don’t know your competition. Either way, there are challenges to overcome. For example, if you are trying to launch a new topical adhesive made from cyanoacrylate—”Dermabond” might be the first predicate device that comes to mind.

Step 2 – Search the Registration Database for FDA Device Classification

Use the registration and listing database on the FDA website to find the company that manufacturers the device. The link for this is #4 on my helpful links page (updated). This link also will provide you with connections to the classification database—which you can use to find the classification for any device. However, the registration and listing database is less likely to lead you astray. When I type “Dermabond” into the field for the proprietary device name, I get a list of five different product listings.

Step 3 – Select one of the competitor links to identify the FDA Device Classification

Clicking on any one of these five will take you to a listing page for the corresponding company. On that page, you will find the three-letter product code that identifies the device classification and the applicable regulations for that device.

Step 4 – Your found the FDA Device Classification

Clicking on the three-letter product code (i.e., – “MPN” in our Dermabond example) takes you to the Product Classification page. This is where you will find that Dermabond, and other tissue adhesives, are Class II devices that require a 510(k) submission. Also, the Product Classification page identifies an applicable guidance document to follow for design verification and validation testing. This is also called the “Special Controls Document.”

Step 5 – TheTPLC Report lists all the recent 510(k) submissions

Click on the “TPLC Product Code Report” link. This link will provide you with a report of all the 510(k) ‘s recently granted to your competitors, problems customers have experienced with their products, and recalls for the past five years. This is extremely valuable information as a design input—as well as competitive information for your marketing team.

tplc total product life cycle report for mpn How to request FDA Device Classification 513(g) Alternative — TPLC Report for Product Code “MPN” – Topical Adhesive

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