MedTech Dive February 1, 2024
The agency extended the transition from one to two years, pushing back the effective date to 2026.
Dive Brief:
- The Food and Drug Administration published a final rule Wednesday to harmonize aspects of quality management system (QMS) requirements with the international standard.
- Officials finalized the text after reviewing feedback on the 2022 proposed rule. The FDA said almost all respondents supported the goal of updating and modernizing the current good manufacturing practice (cGMP) requirements by incorporating ISO 13485.
- Acting on points raised in the consultation, the agency has made changes to the proposed rule, “primarily for clarity and accuracy and to improve understanding of the requirements of the [QMS regulation],” and extended the transition timeline from one to...
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