tine practice involve review of data collected in the pilot study and elsewhere by both FDA and a policy-making body, usually at the state level, that is independent of the organization directly responsible for conducting the pilot study. A national oversight body (see Chapter 9) could facilitate collection and dissemination of data from pilot "investigational" studies. An adequately conducted pilot study in one or a few states need not be repeated in others as long as the other state(s) can maintain the same standards of the pilot study in routine operation. The committee also recommends that some mechanism be found to resolve the dilemma posed by the need to demonstrate that the device is safe and effective for its intended use, whether or not it will be commercially marketed.

The preceding sections, as well as other chapters in this report, indicate that genetic tests for screening and other purposes differ in many respects from other laboratory tests. Some federal agencies, particularly FDA, have recognized this by planning special guidance for manufacturers of genetic tests and by inviting geneticists to participate on advisory groups. The committee welcomes such activity and encourages other agencies to do likewise. In particular, the committee recommends a Genetic Device Advisory Panel to provide FDA with continuing and timely access to expert advice. In addition, the Clinical Laboratory Improvement Advisory Council should appoint a subcommittee on genetics to make recommendations on improving the quality of laboratories performing genetic tests under CLIA88.


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Benn, P., et al. 1992. A rapid (but wrong) prenatal diagnosis. New England Journal of Medicine 326(24): 1638-1639.

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