![]() ![]() The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The proposed rulemaking is not anticipated to be issued until April 2019, which is subject to change after review and approval by the Office of Budget and Management. The regulatory agenda provides that:įDA intends to harmonize and modernize the Quality System regulation for medical devices. The rulemaking entitled “Harmonizing and Modernizing Regulation of Medical Device Quality Systems” appears on FDA’s regulatory agenda. Part 820) with an international consensus standard for medical device manufacturing (ISO 13485). Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. FDA recently announced a potential massive overhaul to its Medical Device regulations.
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