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- W4299402009 abstract "The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters." @default.
- W4299402009 created "2022-10-02" @default.
- W4299402009 date "1997-12-23" @default.
- W4299402009 modified "2023-09-29" @default.
- W4299402009 title "Medical devices; refurbishers, rebuilders, reconditioners, servicers, and as is remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking." @default.
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