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2. Regulation of medical software by the Food and Drug Administration. Jorgens J; Schneider RH Softw Healthc; 1985; 3(2):27-9. PubMed ID: 10278374 [No Abstract] [Full Text] [Related]
3. Assessment of adverse drug reactions in the hospital setting: considerations. Jones JK Hosp Formul; 1979 Aug; 14(8):769-72, 774, 776. PubMed ID: 10243167 [No Abstract] [Full Text] [Related]
4. Myths and realities in medical packaging. Pilchik R Med Device Technol; 2003 Mar; 14(2):16-7. PubMed ID: 12698692 [TBL] [Abstract][Full Text] [Related]
5. Food and Drug Administration Modernization Act of 1997: medical device provisions. Pilot LR; Waldmann DR Food Drug Law J; 1998; 53(2):267-95. PubMed ID: 10346685 [No Abstract] [Full Text] [Related]
6. How do regulatory agencies ensure the release of a safe medical device? Haggar B Clin Perform Qual Health Care; 1999; 7(2):100-3. PubMed ID: 10747561 [TBL] [Abstract][Full Text] [Related]
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8. Section 8(c) of the proposed Restatement (Third) of Torts: is it really what the doctor ordered? Winchester JD Cornell Law Rev; 1997 Mar; 82(3):644-93. PubMed ID: 10343053 [No Abstract] [Full Text] [Related]
9. 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]
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12. New US agent requirements. Donawa M Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780 [TBL] [Abstract][Full Text] [Related]
13. Governmental regulation of medical devices. Goodwin G Respir Care; 1988 Apr; 33(4):251-7. PubMed ID: 10315748 [No Abstract] [Full Text] [Related]
14. Medical device regulation in the United States and the European Union: a comparative study. Chai JY Food Drug Law J; 2000; 55(1):57-80. PubMed ID: 12296349 [No Abstract] [Full Text] [Related]
15. FDA "approval" of medical devices. Health Devices; 1999; 28(5-6):235. PubMed ID: 10412079 [No Abstract] [Full Text] [Related]
16. Establishing a software quality assurance program for microprocessor-based medical equipment. Fries RC; Heide PW Med Instrum; 1986; 20(3):156-61. PubMed ID: 3724590 [No Abstract] [Full Text] [Related]
18. Enforcement policy: recalls (including product corrections)--guidelines on policy, procedures, and industry responsibilities. Fed Regist; 1978 Jun; 43(117):26201-21. PubMed ID: 10316619 [No Abstract] [Full Text] [Related]
19. Micromatrix. Computers, medicine, and quality control. Grundner TM Health Matrix; 1984; 2(1):57. PubMed ID: 10278285 [TBL] [Abstract][Full Text] [Related]
20. The preemptive scope of the Medical Device Amendments of 1976. Sunshine PH Food Drug Law J; 1995; 50(1):191-212. PubMed ID: 10342991 [No Abstract] [Full Text] [Related] [Next] [New Search]