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Home » Industry Backs FDA Proposal to Revise Device Quality Rules, But Asks for More Time
Industry Backs FDA Proposal to Revise Device Quality Rules, But Asks for More Time
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday.
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