Medical devices; medical device user facility and manufacturer reporting, certification and registration; Office of Management and Budget approval; extension of effective date--FDA. Final rule; notification of approval of information collection requirements.
D003625:Data Collection / Q000592:standards; D018795:Device Approval; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration