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PUBMED FOR HANDHELDS

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]

  • 22. The FDA's humanitarian device exemption program.
    Eydelman MB, Chen EA.
    Health Aff (Millwood); 2011 Jun; 30(6):1210-2; author reply 1212. PubMed ID: 21653975
    [No 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]

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  • 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
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  • 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]

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  • 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]


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