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Pubmed for Handhelds
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Journal Abstract Search
206 related items for PubMed ID: 34405782
21. Regulation of drugs and devices: an evolution. Merrill RA. Health Aff (Millwood); 1994; 13(3):47-69. PubMed ID: 7927161 [Abstract] [Full Text] [Related]
23. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule. Fed Regist; 2000 Apr 12; 65(71):19650-8. PubMed ID: 11010632 [Abstract] [Full Text] [Related]
24. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015. Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Ophthalmology; 2017 Aug 12; 124(8):1237-1246. PubMed ID: 28501378 [Abstract] [Full Text] [Related]
25. The need for federal preemption of state tort claims in the context of "new drugs" and premarket-approved medical devices. Mottes LM. Seton Hall Law Rev; 2011 Aug 12; 41(2):723-63. PubMed ID: 21739761 [No Abstract] [Full Text] [Related]
26. Regulatory aspects of invasive glucose measurements. Gutman S, Bernhardt P, Pinkos A, Moxey-Mims M, Knott T, Cooper J. Diabetes Technol Ther; 2002 Aug 12; 4(6):775-7. PubMed ID: 12685800 [Abstract] [Full Text] [Related]
28. Off-label use of medical devices in radiology: regulatory standards and recent developments. Smith JJ. J Am Coll Radiol; 2010 Aug 12; 7(2):115-9. PubMed ID: 20142085 [Abstract] [Full Text] [Related]
29. FDA recognition of consensus standards in the premarket notification program. Marlowe DE, Phillips PJ. Biomed Instrum Technol; 1998 Aug 12; 32(3):301-4. PubMed ID: 9619259 [Abstract] [Full Text] [Related]
30. Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation. Kramer DB, Tan YT, Sato C, Kesselheim AS. Food Drug Law J; 2014 Aug 12; 69(1):1-23, i. PubMed ID: 24772683 [Abstract] [Full Text] [Related]
32. FDA's new regulatory paradigms for in vitro diagnostic devices. Robinowitz M, Gutman SI. Cytotherapy; 1999 Aug 12; 1(4):353-7. PubMed ID: 20426566 [No Abstract] [Full Text] [Related]
33. How many testers are needed to assure the usability of medical devices? Borsci S, Macredie RD, Martin JL, Young T. Expert Rev Med Devices; 2014 Sep 12; 11(5):513-25. PubMed ID: 25033757 [Abstract] [Full Text] [Related]
34. Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation. Cho T, Gowda V, Schulzrinne H, Miller BJ. Milbank Q; 2024 Jun 12; 102(2):367-382. PubMed ID: 38253988 [Abstract] [Full Text] [Related]
37. Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health. Ronquillo JG, Zuckerman DM. Milbank Q; 2017 Sep 12; 95(3):535-553. PubMed ID: 28895231 [Abstract] [Full Text] [Related]
38. Pharmaceuticals and Medical Devices: FDA Oversight. White RS, Thomson Reuters Accelus.. Issue Brief Health Policy Track Serv; 2017 Dec 26; 2017():1-33. PubMed ID: 29361662 [No Abstract] [Full Text] [Related]
39. Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule. Fed Regist; 1998 Apr 27; 63(80 Pt 1):20530-3. PubMed ID: 10179319 [Abstract] [Full Text] [Related]
40. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment. Roller ST, Pippins RR, Ngai JW. Food Drug Law J; 2009 Apr 27; 64(3):577-98. PubMed ID: 19999646 [Abstract] [Full Text] [Related] Page: [Previous] [Next] [New Search]