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    Results: 1 to 20 of 843

    1.

    Medical device regulation: an introduction for the practicing physician.

    Maisel WH.

    Ann Intern Med. 2004 Feb 17;140(4):296-302. Review.PMID: 14970153 [PubMed - indexed for MEDLINE]Related articlesFree article

    2.

    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. Review.PMID: 17894274 [PubMed - indexed for MEDLINE]Related articles

    3.

    US and European postmarket clinical data requirements.

    Donawa M.

    Med Device Technol. 2005 Mar;16(2):19-21.PMID: 15828495 [PubMed - indexed for MEDLINE]Related articles

    4.

    Postmarket surveillance. Final rule.

    Food and Drug Administration, HHS.

    Fed Regist. 2002 Jun 6;67(109):38878-92.PMID: 12053947 [PubMed - indexed for MEDLINE]Related articlesFree article

    5.

    Who should protect the public? The Supreme Court and medical device regulation.

    Korobkin R.

    N Engl J Med. 2007 Oct 25;357(17):1680-1. No abstract available. PMID: 17960010 [PubMed - indexed for MEDLINE]Related articles

    6.

    The impact of FDA reform.

    Trunzo J.

    Med Device Technol. 2003 Apr;14(3):36-7.PMID: 12789699 [PubMed - indexed for MEDLINE]Related articles

    7.

    U.S. medical device reporting: who is responsible?

    Donawa M.

    Med Device Technol. 2005 Apr;16(3):27-9.PMID: 15871421 [PubMed - indexed for MEDLINE]Related articles

    8.

    Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

    Feldman MD, Petersen AJ, Karliner LS, Tice JA.

    J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. Review.PMID: 18095046 [PubMed - indexed for MEDLINE]Related articlesFree article

    9.

    What the code of federal regulations means to you.

    Yellin A.

    Biomed Instrum Technol. 2005 Jul-Aug;39(4):285-7. No abstract available. PMID: 16111404 [PubMed - indexed for MEDLINE]Related articles

    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. Review.PMID: 18460686 [PubMed - indexed for MEDLINE]Related articles

    11.

    Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.

    [No authors listed]

    Fed Regist. 2000 Jan 26;65(17):4112-21.PMID: 11010653 [PubMed - indexed for MEDLINE]Related articlesFree article

    12.

    FDA pilot programme in support of global harmonisation.

    Donawa ME.

    Med Device Technol. 2003 Nov;14(9):32-4.PMID: 14682021 [PubMed - indexed for MEDLINE]Related articles

    13.

    Devices and the food and drug administration.

    Phillips SJ, Phillips RS.

    Artif Organs. 2005 May;29(5):363-5. No abstract available. PMID: 15854210 [PubMed - indexed for MEDLINE]Related articles

    14.

    Beyond the US submisson process.

    Donawa M.

    Med Device Technol. 2004 Apr;15(3):30-2.PMID: 15255536 [PubMed - indexed for MEDLINE]Related articles

    15.

    Legal overprotection.

    Friedman JH.

    Med Health R I. 2004 Oct;87(10):294. No abstract available. PMID: 15559378 [PubMed - indexed for MEDLINE]Related articles

    16.

    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.

    [No authors listed]

    Fed Regist. 1996 Apr 11;61(71):16043-5. No abstract available. PMID: 10157704 [PubMed - indexed for MEDLINE]Related articles

    17.

    Pin the tail on the other donkey: allocating and avoiding injury losses after drug or device approval.

    O'Reilly JT.

    Food Drug Law J. 2007;62(3):559-72. No abstract available. PMID: 17915397 [PubMed - indexed for MEDLINE]Related articles

    18.

    Primer on medical device regulation. Part II. Regulation of medical devices by the U.S. Food and Drug Administration.

    Monsein LH.

    Radiology. 1997 Oct;205(1):10-8. No abstract available. PMID: 9314953 [PubMed - indexed for MEDLINE]Related articlesFree article

    19.

    Semper fidelis--consumer protection for patients with implanted medical devices.

    Maisel WH.

    N Engl J Med. 2008 Mar 6;358(10):985-7. No abstract available. PMID: 18322280 [PubMed - indexed for MEDLINE]Related articles

    20.

    Postmarket evaluation of breakthrough technologies.

    Rao SV, Califf RM, Kramer JM, Peterson ED, Gross TP, Pepine CJ, Williams DO, Donohoe D, Waksman R, Mehran R, Krucoff MW.

    Am Heart J. 2008 Aug;156(2):201-8.PMID: 18657647 [PubMed - indexed for MEDLINE]Related articles

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