Patient access to medical devices - A comparison of U.S. and European review processes

New England Journal of Medicine

Volumn 367, Issue 6, 2012, Pages 485-488

  Basu, Saptarshi ^a   Hassenplug, John C ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; DEVICE APPROVAL; DEVICE SAFETY; EUROPE; HEALTH CARE ACCESS; HUMAN; MEDICAL DEVICE; PRIORITY JOURNAL; REIMBURSEMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY; UNITED STATES; VALIDATION PROCESS;

EID: 84864669609     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1204170     Document Type: Article

References (5)

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2. Medical Device Network. Payback time. December 10, 2008 (http://www.medicaldevicenetwork. com/features/feature48597/).
3. FDA medical product approval times, fiscal year 2011: report in response to House report 2112. Silver Spring, MD: Food and Drug Administration, March 7, 2012.
4. Centers for Medicare & Medicaid Services. Coverage information exchange: reports for FY 2006-2010 (http://www.cms.gov/InfoExchange/04-reports. asp#TopOfPage).
5. Schreyögg J, Baumler M, Busse R. Balancing adoption and affordability of medical devices in Europe. Health Policy 2009;92:218-24. [Erratum, Health Policy 2010;94:90.]