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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 revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Cond.. 2010-01-22 18:07:03 
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Subject :US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT

Dear Friends,

FDA issues revised ICH Guidance: "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals."

Discusses the types of nonclinical studies, their scope and duration, and their relationship to the conduct of human clinical trials.

Federal Register listing: http://edocket.access.gpo.gov/2010/pdf/2010-1027.pdf

Guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

Kind Regards,

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