Program Integrity Memorandum #I89-1
October 25, 1989 Integrity of the Medical Device Review Process Purpose. 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. Procedure. 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.