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- Title
BE CAREFUL WHAT YOU ASK FOR: THE FDA'S DENIALS OF CITIZEN PETITIONS CONFIRMS THERE IS NO SUCH THING AS A LIMITED PREMARKET APPROVAL.
- Authors
Schultz, David T.; Aberson, D. Scott
- Abstract
The article discusses the U.S. Food and Drug Administration's (FDA's) premarket approval (PMA) process regarding the sale of Class III medical devices (MDs) in America as of 2012, and it mentions cost-benefit analyses, as well as the FDA's denials of citizen petitions to amend its approval letters to limit the scope of PMA. A U.S. preemption doctrine is examined, along with the nation's Medical Device Amendments of 1976 statute and the MD law-related case Riegel v. Medtronic Inc.
- Subjects
UNITED States; MEDICAL device approval; PETITIONS; MEDICAL equipment laws; UNITED States. Food &; Drug Administration; EXCLUSIVE &; concurrent legislative powers; RIEGEL v. Medtronic Inc. (Supreme Court case); COST effectiveness; MEDICAL equipment; PRICES
- Publication
William Mitchell Law Review, 2012, Vol 38, Issue 4, p1157
- ISSN
0270-272X
- Publication type
Article