These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

376 related items for PubMed ID: 34342614

  • 1. FDA Regulation and Approval of Medical Devices: 1976-2020.
    Darrow JJ, Avorn J, Kesselheim AS.
    JAMA; 2021 Aug 03; 326(5):420-432. PubMed ID: 34342614
    [Abstract] [Full Text] [Related]

  • 2. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ, Avorn J, Kesselheim AS.
    JAMA; 2020 Jan 14; 323(2):164-176. PubMed ID: 31935033
    [Abstract] [Full Text] [Related]

  • 3. 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 14; 95(3):535-553. PubMed ID: 28895231
    [Abstract] [Full Text] [Related]

  • 4.
    ; . PubMed ID:
    [No Abstract] [Full Text] [Related]

  • 5. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
    Heneghan CJ, Goldacre B, Onakpoya I, Aronson JK, Jefferson T, Pluddemann A, Mahtani KR.
    BMJ Open; 2017 Dec 06; 7(12):e017125. PubMed ID: 29212782
    [Abstract] [Full Text] [Related]

  • 6.
    ; . PubMed ID:
    [No Abstract] [Full Text] [Related]

  • 7. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
    Scott B.
    Food Drug Law J; 2011 Dec 06; 66(3):377-404, ii. PubMed ID: 24505854
    [Abstract] [Full Text] [Related]

  • 8.
    ; . PubMed ID:
    [No Abstract] [Full Text] [Related]

  • 9.
    ; . PubMed ID:
    [No Abstract] [Full Text] [Related]

  • 10. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
    Samuel AM, Rathi VK, Grauer JN, Ross JS.
    Clin Orthop Relat Res; 2016 Apr 06; 474(4):1053-68. PubMed ID: 26584802
    [Abstract] [Full Text] [Related]

  • 11. Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.
    Kadakia KT, Beckman AL, Ross JS, Krumholz HM.
    JAMA Intern Med; 2022 Jan 01; 182(1):59-65. PubMed ID: 34842892
    [Abstract] [Full Text] [Related]

  • 12. Medical devices: US medical device regulation.
    Jarow JP, Baxley JH.
    Urol Oncol; 2015 Mar 01; 33(3):128-32. PubMed ID: 25458071
    [Abstract] [Full Text] [Related]

  • 13. Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.
    Maxwell K.
    Am J Law Med; 2021 Jul 01; 47(2-3):291-326. PubMed ID: 34405782
    [Abstract] [Full Text] [Related]

  • 14. An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.
    Tylenda CA, Weintraub M.
    Ann Periodontol; 1997 Mar 01; 2(1):11-7. PubMed ID: 9151539
    [Abstract] [Full Text] [Related]

  • 15. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.
    Dubin JR, Simon SD, Norrell K, Perera J, Gowen J, Cil A.
    JAMA Netw Open; 2021 May 03; 4(5):e217274. PubMed ID: 33956132
    [Abstract] [Full Text] [Related]

  • 16. An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
    Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.
    IEEE Trans Neural Syst Rehabil Eng; 2007 Sep 03; 15(3):421-4. PubMed ID: 17894274
    [Abstract] [Full Text] [Related]

  • 17. FDA regulation of cardiovascular devices and opportunities for improvement.
    Dhruva SS, Redberg RF.
    J Interv Card Electrophysiol; 2013 Mar 03; 36(2):99-105. PubMed ID: 23263896
    [Abstract] [Full Text] [Related]

  • 18. ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.
    O'Neill T, Miksad R, Miller D, Maloney L, John A, Hiller C, Hornberger J.
    Value Health; 2019 Jul 03; 22(7):754-761. PubMed ID: 31277820
    [Abstract] [Full Text] [Related]

  • 19. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
    Rome BN, Kramer DB, Kesselheim AS.
    JAMA; 2019 Jul 03; 311(4):385-91. PubMed ID: 24449317
    [Abstract] [Full Text] [Related]

  • 20. User fees and beyond--the FDA Safety and Innovation Act of 2012.
    Kramer DB, Kesselheim AS.
    N Engl J Med; 2012 Oct 04; 367(14):1277-9. PubMed ID: 23034017
    [No Abstract] [Full Text] [Related]

    Page: [Next] [New Search]
    of 19.