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Final rule regarding amendment of 21 CFR Part 820 & 21 CFR Part 4
The FDA has issued a final rule harmonising the Quality System regulation with ISO 13485:2016. An overview of what the rule changes, the transitional period, and the implications for manufacturers.
FDA Update
The Food and Drug Administration (FDA) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. The new regulation will incoporating reference to ISO 13485 medical device management system standard (edition 2016) and allows manufacturers to profit not only from cost savings, but also from improved time to market.
Transitional period of 2 years: The new regulation came into effect on 2 February 2026.
Also FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products whereas these edits do not impact the CGMP requirements for combination products.
Please see here for more details.
KEY TAKEAWAY
FDA Harmonises QSR with ISO 13485
The FDA has issued a final rule amending the device Current Good Manufacturing Practice requirements of the Quality System regulation, incorporating reference to ISO 13485:2016 to harmonise and modernise the regulation. The rule comes into effect on 2 February 2026 following a two-year transitional period, offering manufacturers cost savings and improved time to market. Conforming edits have also been made to 21 CFR Part 4 to clarify QMS requirements for combination products without changing the underlying CGMP requirements.
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