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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :FDA Issues Draft Guidance on IRB Continuing Review.. 2010-01-14 04:07:29 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

FDA has issued draft guidance on "IRB Continuing Review after Clinical Investigation Approval."  The guidance document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf.

This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.  The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.  When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration).

Kind regards,

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