Episode description
This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product clearance/approval.
Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination, so they bring incredibly fresh insight on the process. These panelists include a former FDA CDRH rep who worked on appeals from the FDA side, as well as Mark DuVal of DuVal & Associates, PA: a law practice with a truly excellent success rate in FDA appeals.
Our Live! show discussion will include:
- Case study of a successful appeal
- What does the appeals process really look like?
- Will an appeal damage your relationship with FDA?
- What scenarios are good candidates for an appeal?
- Why are appeals increasing?
- Stories of wins and losses
Panelists:
- Mark DuVal, J.D. FRAPS – President, DuVal & Associates, PA
- Daniel Clark – President/COO/Co-Founder, Linear Health Sciences
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer), RQM+
Timestamps:
3:07 -- Dan, this is your story. Could you give us the highlights?
8:37 -- [Mark takes over]
13:23 -- [Mark discusses clinical position]
14:55 -- [More outlining of lengths Linear had to go through to accomplish this]
20:29 -- Besides technical issues, did you have any administrative problems?
24:30 -- Was Linear's experience typical or does this look different than most of your appeals?
26:46 -- Do most startups fold long before this?
28:19 -- What's it like on the FDA side of these appeals?
30:34 -- Is there insight you can provide to those listening? How as a sponsor can we get to those dialogues?
35:47 -- How does FDA feel when they're being challenged in these appeals?
40:20 -- Is everyone even talking? Does it matter that there are 483s in one division and another division is doing an appeal?
41:33 -- What are some scenarios that are good candidates for an appeal?
47:12 -- Are you see an increase in appeals?
53:03 -- We submitted a Pre-sub and it took 10 months for a response (after they changed the date 3 times) and when we got the feedback the questions weren't even answered just pointed to guidance docs and no opportunity to discuss the feedback as an option provided.
54:10 -- What recommendations would you have for FDA to provide the PhD graduates with the appropriate regulatory perspective? How might the industry help FDA?