Issues associated with off label use of medical devices

Annual International Conference of the IEEE Engineering in Medicine and Biology - Proceedings

Volumn , Issue , 2007, Pages 3556-3558

  David, Yadin ^a   Hyman, William A ^b  

^a TEXAS CHILDREN S HOSPITAL   (United States)

^b TEXAS A AND M UNIVERSITY   (United States)

Author keywords

Clinical use; EC; FDA; Instruction for use; Label; Medical devices; Regulation; Risk

Indexed keywords

DEVICE LABELING; LABEL USE; MEDICAL DEVICES;

LABELS; LAWS AND LEGISLATION; MEDICAL APPLICATIONS; RISK ANALYSIS;

BIOMEDICAL EQUIPMENT;

LABELS; MEDICAL SURGICAL SUPPLIES; REGULATIONS; RISK ASSESSMENT;

ARTICLE; DECISION SUPPORT SYSTEM; DEVICE APPROVAL; DEVICES; HEALTH CARE QUALITY; METHODOLOGY; POSTMARKETING SURVEILLANCE; QUESTIONNAIRE; RISK ASSESSMENT; STANDARD; UNITED STATES;

DECISION SUPPORT TECHNIQUES; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY ASSURANCE, HEALTH CARE; QUESTIONNAIRES; RISK ASSESSMENT; UNITED STATES;

EID: 57649216672     PISSN: 05891019     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/IEMBS.2007.4353099     Document Type: Conference Paper

References (4)

1. The 1997 FDA Modernization Act (FDAMA) described certain conditions under which a manufacturer could disseminate information on new uses without incurring regulatory objections.
2. "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices", 21 CFR Parts 16 and 99, Federal Register, Vol. 63, No. 2241, November 20, 1998.
3. Decision in Washington Legal Foundation vs. Henny, Federal Register, Vol. 65, No. 52, 14286-14288, March 16, 2000. See also www.fda.gov/OHRMS/DOCKETS/ 98fr/031688 B.txt.
4. Off Label Use, W.A. Hyman, Journal of Clinical Engineering, 25(5), 277-279, 2000.