July 31, 2011

Institute of Medicine Recommends Stronger Medical Device Oversight

Genetic tests fall into the category of medical devices for the purpose of identifying regulatory requirements administered by the Food and Drug Admistration (FDA). As most commercially available genetic tests are offered as laboratory developes tests (LDT), not retail products, they are largely unregulated by the FDA (save for the separate general oversight of U.S. laboratories under the Clinical Laboratory Improvements Amendments, known as CLIA).  However, the FDA has stepped into some regulation of genetic tests; for example, recommending that developers of pharmacogenomic tests consult with the agency before deciding whether to submit a premarket notification submission -510(k) - or the more demanding premarket approval application. This sporadic regulation of genetic tests has occurred against a backdrop of perceived deficiencies in the overall regulation of medical devices - most notably, criticism that too many moderate-risk medical device suppliers are allowed to simply notify the FDA of a new device entering the market, rather than request approval of such action.  Further elaboration is available in this summary document from the Government Accountability Office. This week's report of a lengthy study on the 510(k) device clearance process by the Institute of Medicine (IOM) calls for largely scrapping the premarket notification program as it exists in favor of stricter pre- and post- approval mechanisms. The upshot for genetic testing regulation is that more sophisticated classification of genetic tests will likely result in risk sorting that will adjust regulatory demands, and if the FDA begins to tighten the medical device entry process across risk categories, genetic tests are likely to be swept along. The College of American Pathologists, which has called for risk classification and increased regulation of LDTs, notes that the new IOM proposals overlap with their own calls for LDT regulation. 

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