BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

472 related articles for article (PubMed ID: 15984543)

  • 1. US importer and distributor requirements.
    Donawa M
    Med Device Technol; 2005 Jun; 16(5):25-7. PubMed ID: 15984543
    [TBL] [Abstract][Full Text] [Related]  

  • 2. FDA pilot programme in support of global harmonisation.
    Donawa ME
    Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Foreign Establishment Registration and United States agent requirements.
    Nolte CJ; McNamara-Cullinane M
    Med Device Technol; 2002 Dec; 13(10):32-3. PubMed ID: 12575528
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Addressing US and European device testing requirements.
    Donawa M
    Med Device Technol; 2008 Sep; 19(5):32, 34-7. PubMed ID: 18947148
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Beyond the US submisson process.
    Donawa M
    Med Device Technol; 2004 Apr; 15(3):30-2. PubMed ID: 15255536
    [TBL] [Abstract][Full Text] [Related]  

  • 6. US and European postmarket clinical data requirements.
    Donawa M
    Med Device Technol; 2005 Mar; 16(2):19-21. PubMed ID: 15828495
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Medical device reporting: the US final rule.
    Donawa ME
    Med Device Technol; 1996 Mar; 7(2):14-6, 18, 20-1. PubMed ID: 10159867
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Import for export; reporting and recordkeeping requirements for unapproved or violative products imported for further processing or incorporation and subsequent export--FDA. Proposed rule.
    Fed Regist; 1998 Nov; 63(226):64930-7. PubMed ID: 10338872
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Jan; 65(17):4112-21. PubMed ID: 11010653
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Organising European technical documentation to avoid duplication.
    Donawa M
    Med Device Technol; 2006 Apr; 17(3):29-31. PubMed ID: 16736662
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments.
    Fed Regist; 1993 Sep; 58(168):46514. PubMed ID: 10128334
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Medical devices; medical device user facility and manufacturer reporting, certification and registration; Office of Management and Budget approval; extension of effective date--FDA. Final rule; notification of approval of information collection requirements.
    Fed Regist; 1996 Apr; 61(71):16043-5. PubMed ID: 10157704
    [No Abstract]   [Full Text] [Related]  

  • 13. New US agent requirements.
    Donawa M
    Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780
    [TBL] [Abstract][Full Text] [Related]  

  • 14. European Animal Tissue Directive.
    Donawa M
    Med Device Technol; 2004; 15(1):28-31. PubMed ID: 14994636
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Meeting US and European supplier control requirements.
    Donawa M
    Med Device Technol; 2009; 20(3):24-7. PubMed ID: 19626952
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Recent legal developments affecting medical device manufacturers.
    Lough MH
    Healthspan; 1993 Sep; 10(8):21-3. PubMed ID: 10129148
    [No Abstract]   [Full Text] [Related]  

  • 17. 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; 15(3):421-4. PubMed ID: 17894274
    [TBL] [Abstract][Full Text] [Related]  

  • 18. IVD authorized representatives.
    Donawa ME
    Med Device Technol; 2003 May; 14(4):19-21. PubMed ID: 12774572
    [TBL] [Abstract][Full Text] [Related]  

  • 19. FDA is gold standard of review.
    Leahey MB
    BMJ; 2010 Dec; 341():c7004. PubMed ID: 21139000
    [No Abstract]   [Full Text] [Related]  

  • 20. Differing definitions of manufacturer.
    Donawa ME
    Med Device Technol; 1998; 9(6):14-7. PubMed ID: 10182120
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 24.