FDA: The Regulatory Process

Public law 101-629. 104 Statute 4511. Safe medical devices act of 1990. November 28, 1990. Federal Register 1990;45(13):3751–3759.

Ziporyn T. The Food and Drug Administration: how those regula- tions came to be. JAMA. 1985;254(15):2037–2039, 2043-2046.

Kessler DA , Pape SM , Sundwall DN . The federal regulation of medical devices. N Engl J Med 1987;317(6):357–366.

Samuel FEJ . Safe medical devices Act of 1990. Health Aff 1991;10(1):192–195.

Investigational device exemptions manual. Rockville, Maryland: U.S. Department of Health and Human Services, 1992.

Pre-market notification 510(k): Regulatory requirements for med- ical devices. Rockville, Maryland: U.S. Department of Health and Human Services, 1992.

Pre-market application (PMA) manual. Rockville, Maryland: U.S. Department of Health and Human Services, 1993.

CFR, Chapter 21. Part 814.

Appler WD , McMann GL . FDA in the 1990s. American Pharmacy. 1990;NS30(5):27–32.

Pillar P. Nursing & Technology: The safety of medical devices and the role of the FDA. Nursing Economics. 1991;9(4):284–286.

Bowsher C. Statement to the subcommittee on health and the en- vironment, committee on energy and commerce, house of repre- sentatives (GAO/T-PEMD-90-2). Washington DC: General Accounting Office, 1989.

Shedlin R. The FDA: Is it protecting the public with one hand tied behind its back? Law, Medicine & Health Care. 1992;20(3):253–257.

Kessler DA . FDA's revitalization of medical device review and reg- ulation. Biomed Instrum Technol. 1994;28(3):220–226.

Samuel FE Jr . On FDA's future. American Pharmacy. 1991;NS31(8):35–37.

Martin S. Two panels say FDA needs better management, should be independent. American Pharmacy. 1991;NS31(8):34–36.

Watson JT . Food and drug administration guidance sections. A new paradigm for medical devices. ASAIO J. 1994;40(2):138–144.

Iglehart JK . The Food and Drug Administration and its problems. N Engl J Med 1991;325(3):217–220.