FDA Pre-Market Approval and Medtronic

By February 22, 2008Briefly Legal, Health Care

The Supreme Court’s ruling in Riegel v. Medtronic reminds one of how involved and safety-conscious the FDA pre-market approval process is. Phew.

Premarket approval is a “rigorous” process. Lohr, 518 U. S., at 477. A manufacturer must submit what is typically a multivolume application. FDA, Device Advice— Premarket Approval (PMA) 18, http://www.fda.gov/cdrh/ devadvice/pma/printer.html. It includes, among other things, full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and,when relevant, packing and installation of, such device”; samples or device components required by the FDA; and a specimen of the proposed labeling. §360e(c)(1). Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, 21 CFR§814.44(a) (2007), and may request additional data fromthe manufacturer, §360e(c)(1)(G).

The FDA spends an average of 1,200 hours reviewing each application, Lohr, supra, at 477, and grants premarket approval only if it finds there is a “reasonable assurance” of the device’s “safety and effectiveness,” §360e(d).

Do we really want to replicate state regulation of medical devices sold in interstate commerce? It’s the logical extension of allowing lawsuits under state tort law.

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