Medical device recalls from 2004 to 2006: A focus on class I recalls

Food and Drug Law Journal

Volumn 62, Issue 3, 2007, Pages 581-591

  Villarraga, Marta L ^a   Guerin, Heather L ^a   Lam, Tack ^a  

^a EXPONENT INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AWARENESS; CLASSIFICATION; COMMERCIAL PHENOMENA; DATA ANALYSIS; ENGINEERING; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEALTH PROGRAM; HUMAN; HUMAN FACTORS RESEARCH; LAW; MEDICAL INSTRUMENTATION; POSTMARKETING SURVEILLANCE; QUALITY CONTROL; REVIEW; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; EQUIPMENT; INFORMATION SYSTEM; INFORMED CONSENT; LEGAL ASPECT; LEGAL LIABILITY; SAFETY; STANDARD; STATISTICS; UNITED STATES;

CONSUMER PRODUCT SAFETY; DUTY TO WARN; EQUIPMENT AND SUPPLIES; EQUIPMENT FAILURE; EQUIPMENT SAFETY; HUMANS; INFORMATION MANAGEMENT; LIABILITY, LEGAL; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 35548976739     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (19)

1. FDA's Medical Device Postmarket Transformation Initiative: http://www.fda.gov/cdrh/postmarket/mdpi.html (Last accessed May 26, 2007).
2. http://www.fda.gov/cdrh/recalls/learn.html - 3 (Last accessed May 31, 2007).
3. 21 CFR 7.3(g).
4. 21 CFR 806.2(i).
5. 21 CFR 806.2(d).
6. FDA, Guidance for Industry: Product Recalls, Including Removals and Corrections. 2003, Office of Regulatory Affairs/Office of Enforcement.
7. 21 CFR 7.40.
8. 21 CFR 7.40.
9. http://www.fda.gov/cdrh/recalls (Last accessed May 31, 2007).
10. Available at: http://www.fda.gov/opacom/Enforce.html (Last accessed May 31, 2007).
11. Medical Device Recall database: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfRES/res. cfm (Last accessed May 31, 2007).
12. 510(k) database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfm (Last accessed May 31, 2007).
13. PMA database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/ pma.cfm (Last accessed May 31, 2007).
14. MAUDE database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfMAUDE/search.CFM (Last accessed May 31, 2007).
15. Device Listing database: http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfRL/listing.cfm (Last accessed May 31, 2007).
16. The number of recall actions and recalled products (i.e., Z-numbers) obtained from the enforcement reports for Class I recalls were compared to FDA released numbers for fiscal years 2004 to 2006.
17. 510(k), PMA, MAUDE or FDA Medical Device Listing databases were used to determine device class (I, II or III).
18. http://www.cdc.gov/diabetes/pubs/estimates.htm.
19. http://www.cdc.gov/nccdphp/publications/AAG/dhdsp.htm.