On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the QS regulations in 21 CFR Part 820 in nearly 30 years. The harmonization is welcome news for many device manufacturers that have been required to comply with both FDA’s QS regulations and ISO standards……
By: Foley Hoag LLP
By: Foley Hoag LLP
