The FDA’s 2027 establishment registration renewal period is now open. Medical device manufacturers must renew their registration by 31 December 2026 to maintain compliance and US market access. Discover the updated FDA fees, key deadlines, and essential renewal requirements.
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Quality Management System Regulation: U.S. FDA implements ISO 1385:2016 for medical devices
The U.S. FDA has replaced the former Quality System regulation with the new Quality Management System Regulation (QMSR), effective 2 February 2026. By incorporating ISO 13485:2016 into 21 CFR 820, the FDA aligns U.S. medical device quality requirements with internationally recognised standards.
Selling cosmetics in California: applicable regulatory framework
Selling cosmetics in California means navigating both federal rules under MoCRA and some of the strictest state-level regulations in the US. Beyond MoCRA, brands must comply with California-specific measures such as Proposition 65, the Safe Cosmetics Program, CARB VOC limits, the Toxic-Free Cosmetics Act, and the PFAS-Free Cosmetics Act.