This blog shows you where to find the new FDA regulation for medical device reporting (http://bit.ly/udpated-21CFR803) and the associated guidance document (http://bit.ly/Part803-Guidance). There is also an explanation of how to perform a gap analysis to compare your procedure for medical device reporting against the new 21 CFR 803 (http://bit.ly/Old-21CFR803).
On January 22, 2014, Medical Device Academy posted a blog about how to create your own FDA medical device regulatory updates: http://bit.ly/4Ways-to-Follow-CDRH. That post identified a number of sources on the FDA website where you can locate information about new and revised FDA regulatory requirements. One suggestion was to register for receiving the RSS feeds from the following page: http://bit.ly/CDRH-news-updates. This page is where the FDA’s Center for Devices and Radiological Health (CDRH – http://bit.ly/FDA-CDRH) posts news and updates.
If you registered for the RSS feed from CDRH, then you received an update on February 13, 2014 announcing the new Part 803 regulation for medical device reporting. This is NOT a cause for alarm. The fundamental change is simple:
Medical device manufacturers will no longer be allowed to submit FDA Form 3500A in paper form. It will need to be submitted electronically through the Electronic Submissions Gateway (ESG) (http://bit.ly/ESG-FDA).
This is just another small step for the FDA to move toward digital records, and to integrate with electronic medical records from healthcare providers. The FDA even created a presentation explaining the process for electronic Medical Device Reporting (eMDR). This 8 minute and 45 second presentation is available on the CDRH Learning page: http://bit.ly/CDRH-Learn. Slide 5 of the FDA’s presentation identifies the six steps for obtaining an account for an ESG:
- Get a test account with the ESG
- Send a letter to authenticate your digital identity (http://bit.ly/Non-repudiation-Letter)
- Get a digital certificate
- Contact CDRH (eMDR@fda.hhs.gov)
- Test sending an MDR to CDRH
- CDRH approves production account with the ESG
I have been recommending that my clients switch from submission of the paper FDA Form 3500A to eMDR since 2010, when this training became available. Now, you have 18 months to switch over to eMDR before the August 14, 2015 deadline for implementation. Alternatively, you can also outsource your eMDR reporting to a service provider that already has an ESG (http://bit.ly/outsourcing-complaints).
Comparison of Current & New Regulations
The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (http://bit.ly/udpated-21CFR803), and copied and pasted each section into a Word document. We also did this for the current version (http://bit.ly/Old-21CFR803). Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents. If you would like to download this gap analysis, please visit the following webpage: http://bit.ly/21_cfr_803_gapanalysis.
Gap Analysis of Your Medical Device Reporting Procedure
After you download the gap analysis tool that Medical Device Academy created, then you need to perform your own gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meet the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).
- Download the gap analysis of the new and old versions of 21 CFR 803
- Review and update your own MDR procedure to address the changes to 21 CFR 803 which are identified in the gap analysis
- Apply for an ESG WebTrader account for Low Volume/Single Reports
- Revise your training requirements for anyone responsible for MDRs:
- Complete all four applicable CDRH online trainings (http://bit.ly/CDRH-Learn)
- Pass a quiz demonstrating training effectiveness (http://bit.ly/TrainingExams)
- Review the draft procedure for potential errors or sections that are unclear
- Make any final revisions to the procedure based upon feedback from trainees
- Implement your revised procedure
If you need help completing the above steps, please contact Medical Device Academy by emailing Rob Packard, or by visiting the webpage for Medical Device Academy’s Complaint Handling and Vigilance group (http://bit.ly/chvg_mda).