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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 Final Guidance on Investigator Responsibilities.. 2009-10-30 19:39:40 
Leon
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Joined: 2009-07-13 19:19:42
Posts: 23
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FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects."  The guidance document is now available from FDA's website using the following web link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf.

It is also available as an embedded link on the Good Clinical Practice's Guidance, Information Sheets and Notices web page:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm

This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)).  The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations.  This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects. 
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Last Edited On: 2009-10-30 19:39:40 By Leon for the Reason
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