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ODE Standard Operating Procedures for the Development and Use of Guidance
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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circulated for comment only, the release of the draft document may be authorized by the Division Director, on the "CDRH Draft Guidance Document Release Form", as set forth in Attachment D of the CDRH memorandum.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)
Updated 10/16/1996
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