BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

203 related articles for article (PubMed ID: 18612007)

  • 1. Orthopaedic joint devices: the FDA's short answers to your questions.
    Foy JR; Buch BD
    J Am Acad Orthop Surg; 2008; 16 Suppl 1():S123-8. PubMed ID: 18612007
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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; 474(4):1053-68. PubMed ID: 26584802
    [TBL] [Abstract][Full Text] [Related]  

  • 3. FDA's perspectives on cardiovascular devices.
    Chen EA; Patel-Raman SM; O'Callaghan K; Hillebrenner MG
    J Cardiovasc Transl Res; 2009 Jun; 2(2):143-6. PubMed ID: 20559979
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The U. S. Food and Drug Administration's role in contact lens development and safety.
    Saviola JF; Hilmantel G; Rosenthal AR
    Eye Contact Lens; 2003 Jan; 29(1 Suppl):S160-5; discussion S166, S192-4. PubMed ID: 12772757
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.
    Day CS; Park DJ; Rozenshteyn FS; Owusu-Sarpong N; Gonzalez A
    J Bone Joint Surg Am; 2016 Mar; 98(6):517-24. PubMed ID: 26984921
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.
    Scully CG; Forrest S; Galeotti L; Schwartz SB; Strauss DG
    Ann Emerg Med; 2015 Apr; 65(4):400-3. PubMed ID: 25128009
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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; 124(8):1237-1246. PubMed ID: 28501378
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Off-label use of medical devices in radiology: regulatory standards and recent developments.
    Smith JJ
    J Am Coll Radiol; 2010; 7(2):115-9. PubMed ID: 20142085
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The FDA process for the evaluation and approval of orthopaedic devices.
    Kirkpatrick JS; Stevens T
    J Am Acad Orthop Surg; 2008 May; 16(5):260-7. PubMed ID: 18460686
    [TBL] [Abstract][Full Text] [Related]  

  • 11. FDA medical device approval: things you didn't learn in medical school or residency.
    Buch B
    Am J Orthop (Belle Mead NJ); 2007 Aug; 36(8):407-12. PubMed ID: 17849025
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.
    Barker JP; Simon SD; Dubin J
    J Bone Joint Surg Am; 2017 May; 99(9):711-719. PubMed ID: 28463914
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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; 95(3):535-553. PubMed ID: 28895231
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market: Insights from an FDA Workshop on Orthopaedic Device-Related Infections.
    Goh GS; Tornetta P; Parvizi J
    J Bone Joint Surg Am; 2021 Aug; 103(15):e57. PubMed ID: 34357892
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2004 Oct; 69(191):59132-4. PubMed ID: 15460583
    [TBL] [Abstract][Full Text] [Related]  

  • 16. The FDA's role in medical device clinical studies of human subjects.
    Saviola J
    J Neural Eng; 2005 Mar; 2(1):S1-4. PubMed ID: 15876645
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Pharmaceuticals and medical devices: medical devices. Issue brief.
    Berry MD
    Issue Brief Health Policy Track Serv; 2012 Dec; ():1-35. PubMed ID: 23297445
    [No Abstract]   [Full Text] [Related]  

  • 18. The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.
    Dubin JR; Ibad H; Cil A; Murray M
    J Am Acad Orthop Surg; 2022 Jul; 30(14):658-667. PubMed ID: 35797679
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist.
    Marrone AK
    Tech Vasc Interv Radiol; 2020 Mar; 23(1):100661. PubMed ID: 32192636
    [TBL] [Abstract][Full Text] [Related]  

  • 20. 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; 65(71):19650-8. PubMed ID: 11010632
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.