Regulation of devices

BMJ (Online)

Volumn 341, Issue 7780, 2010, Pages 947-

  Avorn, Jerry ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; ROFECOXIB;

DRUG SURVEILLANCE PROGRAM; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; INDUSTRY; LEADERSHIP; MEDICAL INSTRUMENTATION; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; STENT;

DEVICE APPROVAL; ELECTRIC STIMULATION THERAPY; EPILEPSY; EQUIPMENT SAFETY; EUROPE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78049522356     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.c5730     Document Type: Editorial

References (5)

1. Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 2010;341:10.1136/bmj.c4753.
2. Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004;140:296-302. [Abstract/FREE Full text]
3. Advanced Medical Technology Association. New study highlights safety of FDA's 510(k) review process. 2010. www.advamed.org/MemberPortal/About/NewsRoom /NewsReleases/PR-FDA510-91510.htm.
4. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85. [Abstract/FREE Full text]
5. Mass Device. Boston Scientific, Abbott, Johnson & Johnson embroiled in off-label stents case. 2010. www.massdevice.com/node/5486.