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4. Device standards: the view from the FDA. Cangelosi RJ J Clin Eng; 1980; 5(1):9-12. PubMed ID: 10246341 [TBL] [Abstract][Full Text] [Related]
5. Voluntary consensus standards and the FDA's regulatory program. Gardner S Med Instrum; 1979; 13(4):239-42. PubMed ID: 470665 [No Abstract] [Full Text] [Related]
6. The Safe Medical Devices Act of 1990--FDA. Notice. Fed Regist; 1991 Apr; 56(66):14111-3. PubMed ID: 10111151 [TBL] [Abstract][Full Text] [Related]
7. The FDA's list of devices tracked as of Aug. 29. Hosp Health Netw; 1993 Oct; 67(20):31. PubMed ID: 8401707 [No Abstract] [Full Text] [Related]
8. FDA's revitalization of medical device review and regulation. Kessler DA Biomed Instrum Technol; 1994; 28(3):220-6. PubMed ID: 8061717 [No Abstract] [Full Text] [Related]
9. FDA's focus on consensus standards: the vision, the heartbreak, the hope. Altman MR; Marlowe DE Stand News; 1999 May; 27(5):24-5. PubMed ID: 10558422 [No Abstract] [Full Text] [Related]
10. The FDA's policy on the regulation of computerized medical devices. Furfine CS MD Comput; 1992; 9(2):97-100. PubMed ID: 1573995 [No Abstract] [Full Text] [Related]
11. Medical devices. Part I. A primer on medical device regulation. Drew G FDA Consum; 1986 May; 20(4):24-7. PubMed ID: 10311540 [No Abstract] [Full Text] [Related]
12. Is FDA's medical device evaluation process overly complaisant to industry? Margolis RE Healthspan; 1992; 9(7):19-20. PubMed ID: 10121440 [No Abstract] [Full Text] [Related]
13. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh. Basile EM; Tolomeo D; Gluck E Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744 [TBL] [Abstract][Full Text] [Related]
14. Medical devices. Part II. The Medical Device Amendments 10 years after. Interview by William Rados. Villforth J FDA Consum; 1986 May; 20(4):28-32. PubMed ID: 10311541 [No Abstract] [Full Text] [Related]
15. FDA's new regulatory paradigms for in vitro diagnostic devices. Robinowitz M; Gutman SI Cytotherapy; 1999; 1(4):353-7. PubMed ID: 20426566 [No Abstract] [Full Text] [Related]
16. The regulation of medical devices: new tools for the FDA. Geller JH J Clin Eng; 1977; 2(3):231-40. PubMed ID: 10305478 [No Abstract] [Full Text] [Related]
17. Implementing the Safe Medical Devices Act. Koeler CT Am Nurse; 1993 Apr; 25(4):12. PubMed ID: 8484590 [No Abstract] [Full Text] [Related]
18. The Federal regulation of medical devices. Kessler DA; Pape SM; Sundwall DN N Engl J Med; 1987 Aug; 317(6):357-66. PubMed ID: 3299097 [No Abstract] [Full Text] [Related]