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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 :US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Dis.. 2010-06-13 18:11:41 
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Subject :US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification

Dear friends,

FDA has issued revised information sheet guidance on "Clinical Investigator Administrative Actions - Disqualification."  This document replaces a previous information sheet titled "Clinical Investigator Regulatory Sanctions."

The revised document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214008.pdf.

Kind regards,

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