title: The FDA and the medical device approval process.
authors.forename: Ghislaine
authors.initials: G
authors.lastname: Guez
authors.forename: Arun
authors.initials: A
authors.lastname: Garg
mesh_terms: D018795:Device Approval; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000145:classification; D006801:Humans; D057052:Medical Device Recalls; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration