Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.
The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D005568:Forms and Records Control / Q000331:legislation & jurisprudence; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration