IN JANUARY 1980, the Council on Scientific Affairs was presented a number of issues regarding maternal serum α-fetoprotein (AFP) testing in detection of open neural tube defects (NTDs) (spina bifida, cystica encephalocele, and anencephaly). The Council identified several scientific questions regarding the appropriate use of the test and discussed medicine's concern over the Food and Drug Administration's announced intent to regulate strictly AFP testing. A panel of expert consultants was gathered to advise the Council on this subject.
The concern about the FDA's imminent involvement stemmed from statements made by that agency that it was going to propose regulations pursuant to its statutory authority under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, specifically the "restricted device" provisions,1 for the ostensible purpose of gathering more data on the "safety and efficacy" of the test. The proposed FDA regulations are consistent with the 1979 report
Maternal Serum α-Fetoprotein Monitoring. JAMA. 1982;247(10):1478–1481. doi:10.1001/jama.1982.03320350076040
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