Hello Anon,
The actual content within each of the sections of an IDE submission can vary a little depending on person's interpretation, but I believe the FDA structure and content is quite sufficient to understand the content
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application#sugfor. From my perspective I usually included transportation and shelf life stability studies in the Design and Manufacturing section since this is typically where "validations" are included. The Prior Investigations usually are animal studies, safety studies, First-In-Person studies those type of studies which are more clinically based. Whereas I see non-clinical type of studies like transport and shelf life as part of the design information. If you look at the FDA checklist and 21 CFR 812.20(b) the manufacturing controls talk about processing, packing, storage, and installation, so I view those areas included there. There is also a reference in Prior Investigations about non-clinical studies needing to be GLP and/or justification for not following GLP - so you might think shelf life studies could be included there.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Jul-2020 03:50
From: Anonymous Member
Subject: Report of prior investigations for IDE submission
This message was posted by a user wishing to remain anonymous
Dear Regulatory Community,
I am preparing an IDE submission for the first time. I work at a small company and this is the first time we work without a consultant helping with the IDE preparation (our regulatory correspondent is not involved with assembling the submission). I have a prior submission as a template but I am concerned that the structure that was used in the past might have led to confusion for the FDA, in particular relating to the transportation and shelf life stability study results description.
Where should transportation and shelf life stability studies be described? In the report of prior investigations or in the manufacturing controls? To me it makes more sense to have it in the report of priors but the previous consultant provided that information in the manufacturing controls section. Our device is implantable, non-active and without software.
Thank you in advance for your feedback.