Medical devices; review and revision of compliance policy guides and regulatory requirements for refurbishers, rebuilders, reconditioners, servicers and "as is" remarketers of medical devices; request for comments and information; extension of comment period--FDA. Advance notice of proposed rulemaking; extension of comment period.
The Food and Drug Administration (FDA) is extending to June 29, 1998, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of December 23, 1997 (62 FR 67011). This advance notice announced FDA's intention to review and, as needed, to revise compliance policy guides, amend regulatory requirements and, as appropriate, exercise alternative regulatory approaches regarding the remarketing of used medical devices. The agency is taking this action in response to two requests for extensions. This extension of comment period is intended to allow interested persons additional time to submit comments on the ANPRM.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D017743:Equipment Reuse / Q000331:legislation & jurisprudence* / Q000592:standards; D019983:Guideline Adherence; D014481:United States; D014486:United States Food and Drug Administration