Medical device regulation in the United States and the European Union: a comparative study.
Chai
J Y
JY
Northwestern University Dental School, Chicago, IL, USA.
D018795:Device Approval; D017598:Efficiency, Organizational; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D005062:European Union; D006801:Humans; D007391:International Cooperation; D007883:Legislation, Medical; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D011634:Public Health; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration