Dental device-associated problems: An analysis of fda postmarket surveillance data

Journal of the American Dental Association

Volumn 132, Issue 11, 2001, Pages 1540-1548

  Fuller, Janie ^a   Parmentier, Christine ^a  

^a Ctr Devices Radiological Hlth   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DENTAL EQUIPMENT; DENTAL SURGERY; DENTIST; EQUIPMENT; FACTUAL DATABASE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; INJURY; INSTRUMENTATION; MAXILLOFACIAL INJURY; METHODOLOGY; MOUTH; ORAL SURGERY; POSTMARKETING SURVEILLANCE; PROFESSIONAL STANDARD; STATISTICS; TOOTH IMPLANTATION; UNITED STATES;

DATA COLLECTION; DATABASES, FACTUAL; DENTAL EQUIPMENT; DENTAL IMPLANTATION, ENDOSSEOUS; DENTAL IMPLANTS; DENTAL RESTORATION FAILURE; DENTISTS; EQUIPMENT FAILURE; HUMANS; MAXILLOFACIAL INJURIES; MOUTH; ORAL SURGICAL PROCEDURES; PRODUCT SURVEILLANCE, POSTMARKETING; PROFESSIONAL ROLE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035522807     PISSN: 00028177     EISSN: None     Source Type: Journal    
DOI: 10.14219/jada.archive.2001.0087     Document Type: Article

References (7)

1. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h).
2. Guidelines for evaluating surveillance systems. MMWR Morb Mortal Wkly Rep 1988;37(S-5):1-18.
3. U.S. Food and Drug Administration about the U.S. Food and Drug Administration. Available at: "www.fda.gov/opacom/hpview.html". Accessed June 11, 2001.
4. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360i.
5. Safe Medical Devices Act of 1990, Pub L. No. 101-629, § 104, Stat. 4511 (1990).
6. Medical devices: Early warning of problems is hampered by severe underreporting. Washington: U.S. Government Printing Office; 1986. GAO publication PEMD-87-1:US.
7. Chelinsky E. Medical devices: Underreporting of problems, backlogged systems, and weak statutory support. Washington: U.S. Government Printing Office; 1989. GAO publication T-PEMD-90-3:US.