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
ODE Review Staff
Through: ODE Branch Chief
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.
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authorized by the Division Director, on the "CDRH Draft Guidance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.
This policy is effective immediately.
Susan Alpert, Ph.D., M.D.
Attachment (in pdf version only)