Hi Michael,
I liked this article. Thanks! I don't know the best method for RA professionals to convey what is needed for a submission, maybe others will comment. I have generally been the RA person on the Development Team, driving data, information and activities required for a 510(k) submission.
In the past, I have provided a regulatory strategy document, based on my research related to the company's device, and a checklist listing and describing the required information, along with discussions, to convey the necessary information and data for a 510(k). However, with small or startup companies that don't have experience in 510(k)s they don't seem to fully "get it"/understand until I start asking them for the missing information (after they send me information and I start to write the submission and realize I need or want more information for a clear, persuasive 510(k) application). I charge them for the research I do prior to documenting it in a regulatory strategy document. I tell them prior to me doing research that some of the work will make the 510(k) compiling quicker; however, sometime the companies take a long time between reviewing my research and finalizing the design and then things have changed and/or they forgot what I documented in the strategy document (and it seems they forget to look back at it). Recently, I have been wondering whether I should just give them verbal information (quicker and less research) and then tell them to come back to me when the design is closer to being finalized. The majority of clients seem fine with my current approach. However, one did say that I spent more time on the application than I estimated; he has a very small company and was very cost conscious; my response was that I had to work with him to develop some of the missing information and he accepted my answer (the 510(k) was cleared quickly, which made him happy).
Kind regards,
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Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States
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Original Message:
Sent: 29-Sep-2020 11:42
From: Michael Morton
Subject: Building blocks for successful submissions.
I'll attach a recent publication from Medical Products Outsourcing which compares building a submission to building a house. This may be useful to regulatory professionals as they explain the deliverables necessary for a successful regulatory submission. What other methods do regulatory professionals use to convey this message to functional partners and business leaders?
https://www.mpo-mag.com/contents/view_online-exclusives/2020-09-25/lets-build-this-best-practices-for-utilizing-external-regulatory-expertise/
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Michael Morton RAC, FRAPS
Consultant
Durango CO
United States
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