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Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

578 related items for PubMed ID: 9800008

  • 1. FDA use of international standards in the premarket review process.
    Rechen E, Barth DJ, Marlowe D, Kroger L.
    Biomed Instrum Technol; 1998; 32(5):518-26. PubMed ID: 9800008
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  • 2. FDA recognition of consensus standards in the premarket notification program.
    Marlowe DE, Phillips PJ.
    Biomed Instrum Technol; 1998; 32(3):301-4. PubMed ID: 9619259
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  • 3. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.
    Alder HC.
    Hosp Technol Ser; 1993 Oct; 12(11):1-27. PubMed ID: 10129209
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  • 4. Use and recognition of consensus standards in US premarket submissions.
    Donawa ME.
    Med Device Technol; 1999 Mar; 10(2):13-7. PubMed ID: 10387610
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  • 5. Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule.
    Fed Regist; 1992 Dec 10; 57(238):58400-6. PubMed ID: 10123143
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  • 6. Human factors and the FDA's goals: improved medical device design.
    Burlington DB.
    Biomed Instrum Technol; 1996 Dec 10; 30(2):107-9. PubMed ID: 8673158
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  • 7. Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.
    Fed Regist; 1991 Oct 10; 56(197):51169-70. PubMed ID: 10115059
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  • 8. 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 Oct 10; 64(1):149-69. PubMed ID: 19998744
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  • 11. New FDA draft guidance on premarket submissions.
    Donawa ME.
    Med Device Technol; 1999 Oct 10; 10(8):12-4. PubMed ID: 10724773
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  • 14. Use of standards in the review of medical devices.
    Ho C, Jensen D, Lacy F, Muni N, Reilly S, Mallis E.
    J Electrocardiol; 2005 Oct 10; 38(4 Suppl):171-4. PubMed ID: 16226095
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  • 15. What physicians should know about the regulation of Obstetric and Gynecologic Medical Devices.
    Yin L.
    J Reprod Med; 1983 Jan 10; 28(1):3-11. PubMed ID: 6834344
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  • 16. Designing medical devices for conformance with harmonized standards. The European Community's Medical Devices Directives and their effect on the product development process.
    Fries RC, Graber MD.
    Biomed Instrum Technol; 1995 Jan 10; 29(4):284-92. PubMed ID: 7550495
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  • 17. FDA Modernization Act of 1997: modifications to the list of recognized standards; availability; withdrawal of draft guidance "Use of IEC 60601 standards; medical electrical equipment"--FDA. Notice.
    Fed Regist; 1998 Oct 16; 63(200):55617-30. PubMed ID: 10185835
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  • 20. FDA pilot programme in support of global harmonisation.
    Donawa ME.
    Med Device Technol; 2003 Nov 16; 14(9):32-4. PubMed ID: 14682021
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