Regulation of clinical laboratory information systems after the 1990 amendments to the Food and Drug Act.
Clinical laboratories are among the most sophisticated software users in the modern hospital. The 1990 Medical Device Amendments to the Food and Drug Act caused a significant change in the legal regulation of medical software. The Act replaces the earlier emphasis on premarket approvals with postmarket surveillance. Hospitals and other institutional users are now required to report to the Food and Drug Administration (FDA) product defects that cause injuries or death. The Act also provides for civil penalties. The combination of these factors may lead to enhanced FDA supervision of medical software, particularly with unregistered producers. Clinical laboratories must understand both the regulatory system and their own responsibilities under the Act.
Brannigan
V M
VM
University of Maryland, College Park.
D002984:Clinical Laboratory Information Systems / Q000331:legislation & jurisprudence* / Q000592:standards; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D003284:Contract Services / Q000458:organization & administration; D003625:Data Collection; D004869:Equipment Safety / Q000592:standards*; D005568:Forms and Records Control; D007221:Industry / Q000331:legislation & jurisprudence; D007755:Laboratories, Hospital / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012984:Software / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration