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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 :Office for Human Research Protections (OHRP): Requests for Public Comm.. 2009-11-09 18:43:05 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Subject :Office for Human Research Protections (OHRP): Requests for Public Comment

Dear Colleagues,

OHRP invites public comments on the following guidance documents and topics:

November 6, 2009: Draft Guidance on IRB Continuing Review of Research
November 6, 2009: Draft Guidance on IRB Approval of Research with Conditions

Public comments on any OHRP guidance document are welcome at anytime. For any comments not submitted during an identified comment period, please email comments to ohrp@hhs.gov and insert the title of the specific guidance document in the subject field, or submit comments by mail to:

Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

Best regards,
IP Logged
Last Edited On: 2009-11-09 18:43:05 By GCP HelpDesk for the Reason
GCP HelpDesk
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