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U.S. Department of Health and Human Services

Medical Devices

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ODE Standard Operating Procedures for the Development and Use of Guidance Documents - June 6, 1996 (G96-2)

                                             
         June 6, 1996
         
         Director, Office of Device Evaluation
         
         
         ODE Standard Operating Procedures for the Development and Use of 
         Guidance Documents
         
         ODE Review Staff
         Through: ODE Branch Chief
         
         
         Purpose
         
         The purpose of this memorandum is to establish interim procedures for 
         the development and use of ODE guidance documents while the Agency 
         formulates its strategy for dealing with this important issue.
         

         Procedures
         
         On May 31, 1996, the Deputy Director for Science, CDRH, issued a 
         memorandum entitled "Standard Operating Procedures for the Development 
         and Use of CDRH Guidance Documents".  A copy of this memo is attached 
         for your reference and use.
         
         The Office of Device Evaluation will follow these Center procedures 
         for the development and use of ODE/Division guidance documents with 
         the one exception that if a guidance document is a draft being 
         circulated for comment only, the release of the draft document may be 
         authorized by the Division Director, on the "CDRH Draft Guidance 
         Document Release Form", as set forth in Attachment D of the CDRH 
         memorandum.  The draft's release does not require the signature of the 
         Office Director as indicated in Attachment D.  
           
         Effective Date:
         
         This policy is effective immediately.
         

         
                                             Susan Alpert, Ph.D., M.D.

           Attachment (in pdf version only)