Medical devices - Balancing regulation and innovation

New England Journal of Medicine

Volumn 365, Issue 11, 2011, Pages 975-977

  Curfman, Gregory D ^a   Redberg, Rita F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALLOY; METAL;

CLINICAL EFFECTIVENESS; DEVICE SAFETY; EQUIPMENT DESIGN; FOOD AND DRUG ADMINISTRATION; FOREIGN BODY; HEALTH CARE FINANCING; IMPLANTATION; LAW; MARKETING; MEDICAL INSTRUMENTATION; MEDICAL PRACTICE; MEDICAL TECHNOLOGY; PRIORITY JOURNAL; REOPERATION; RISK ASSESSMENT; SHORT SURVEY;

EID: 80052863459     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1109094     Document Type: Short Survey

References (5)

1. National Hospital Discharge Survey: survey results and products. Atlanta: Centers for Disease Control and Prevention, 2009. (http://www.cdc.gov/nchs/ nhds/nhds- products.htm.)
2. Updated guidance on large diameter metal on metal bearing total hip replacements. London: British Hip Society and British Orthopaedic Association, March 2011. (http:// www.britishhipsociety.com/pdfs/BHS- MOM-THR.pdf.)
3. Testimony of Katherine Korgaokar before the Senate Committee on Aging, Washington, DC, April 13, 2011. (http://aging.senate .gov/events/hr233kk.pdf.)
4. Institute of Medicine. Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. Washington, DC: National Academies Press, 2011.
5. Challoner DR, Vodra WW. Medical devices and health - creating a new regulatory framework for moderate-risk devices. N Engl J Med 2011;365:977-9.