Unique device identification in the service of public health

New England Journal of Medicine

Volumn 367, Issue 17, 2012, Pages 1583-1585

  Gross, Thomas P ^a   Crowley, Jay ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLASSIFICATION; CODING; DATA BASE; DEVICE SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; IMPLANT REGISTRY; MEDICAL DEVICE; MEDICAL ERROR; MEDICAL INFORMATION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; SHORT SURVEY; STANDARD; UNIQUE DEVICE IDENTIFICATION; UNIQUE DEVICE IDENTIFIER;

EID: 84867838791     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1113608     Document Type: Article

References (4)

1. Hauser RG. Here we go again - another failure of postmarketing device surveillance. N Engl J Med 2012;366:873-5.
2. 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.
3. Strengthening our national system for medical device postmarket surveillance. Silver Spring, MD: Food and Drug Administration, September 2012 (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDRH/CDRHReports/ucm301912.htm).
4. Proposed rule: unique device identification system. Silver Spring, MD: Food and Drug Administration, July 2012.