Medical Devices

Policy Development and Review Procedures #I90-1 (blue book memo) (Text Only)

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

  February 15, 1990  

  Policy Development and Review Procedures
  The purpose of this guidance is to establish a
  procedure to assure the regular and timely establishment and review 
  of ODE guidance documents and policies.
  ODE Management Staff.  
  Twice each year, prior to two of the designated ODE management staff 
  meetings, each Division, the Program Operations Staff, and the 
  Program Management Office should review the status of ODE guidance 
  memoranda("Blue Book" memos) to determine whether ODE should 
  consider the issuance of a blue book memo on a topic not yet covered 
  or whether an existing memorandum needs to be updated. The 
  management staff meetings at which the status of ODE guidance 
  documents will be reviewed will be announced in advance. This 
  subject will appear on the agenda for the designated meeting.
  In reviewing the status of ODE guidance documents the directors 
  should  solicit opinions on the status of ODE policies matter from 
  the division or office supervisors and staff members.
  ODE Staff Members.  
  At any time an ODE staff member may suggest a change in ODE's 
  policies and procedures. This could include the modification or 
  deletion of a current policy or the establishment of a new policy.  
  To do so the staff member should raise the matter with his or her 
  immediate supervisor or the division or office director. Any 
  suggestion should be accompanied by a brief written description of 
  the proposed change, its  purpose, and  the potential benefits and 
  burdens that may be realized by adopting the policy. The division 
  director should present the suggestion  at a weekly division 
  directors meeting for discussion. Any change in policy that is 
  appropriate will be implemented through the normal "Blue Book" 
  Effective Date. 
  This policy is effective immediately.


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