USA - FDA issues “final rule“ to amend 21 CFR 820

The FDA has issued a „final rule“ that implements the annouced amendment of 21 CFR 820 (and 21 CFR 4 for combination products) to harmonize the requirements for quality management systems for medical devices with ISO 13485:2016. Formal publication date is 2024-02-02, the rule will be effective 2026-02-02.

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