Medical Devices

Integrity of the Medical Device Review Process 10/25/89 (I89-1)

Program Integrity Memorandum #I89-1


    October 25, 1989


    Integrity of the Medical Device Review Process
    The purpose of this memorandum is to establish a program to
    assure the integrity and equity of the medical device review program.
    This has become important because of the problems that were 
    encountered in the generic drug program. We have no reason to believe 
    that a similar set of problems exists in the review of medical 
    devices. There is, however, a need to establish policies that will 
    provide assurances to the public, industry, and agency officials that 
    we are minimizing the risk of such occurrences. This memorandum 
    announces the establishment of the program. Subsequent memoranda will 
    set forth new policies and procedures dealing with the integrity of 
    the medical device review program.
    As most of you already know, the HHS Office of the Inspector General 
    is currently conducting an investigation of the medical device 
    approval program. Representatives of this office are looking at all 
    aspects of the program, from the basics, such as document security, to 
    the timeliness and equity of our decision-making process. Our office 
    and the Center will also be re-examining the review process. In fact, 
    it is based upon our past reviews and monitoring, as well as our goal 
    to do a timely and high-quality job, that we already have some 
    policies and procedures in place that deal with certain areas of 
    concern. In some cases, however, these policies and procedures have to 
    be committed to writing. In other areas, we will have to develop 
    formal policies and/or revise current ones.
    Program Development. 
    I am asking Carl DeMarco to coordinate and manage
    the development of the necessary policies and procedures for this
    program. If any ODE staff member has any question or ideas about the
    development or implementation of this program, he or she should feel
    free to discuss it with Dr. DeMarco, who can be reached on 427-1072.
    Effective Date. 
    This policy is effective immediately.


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