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 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.
On 12 September 2025, the US Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. FAERS is an interactive tool that provides the public with real-time access to adverse events reports associated with cosmetic products.
Accessing the US medical device market requires manufacturers to comply with several FDA obligations. One of the essential steps – after determining your device access pathway and receiving approval – is to register your company (establishment) and list your devices with the FDA.
Before launching a medical device in the US, manufacturers must understand FDA classification and select the appropriate premarket pathway. This guide outlines key steps for successful market entry.
Washington State proposes a rule to restrict formaldehyde and FRAs in cosmetics. Learn about the potential impact.
Discover the effects of non-compliance with the Modernization of Cosmetics Regulations Act of the FDA to your business and market access.
Discover the effects of non-compliance with the Modernization of Cosmetics Regulations Act of the FDA to your business and market access.
Navigate California’s strict cosmetic regulations with Obelis’ assistance in meeting local reporting requirements under CSCA and CFFIRKA.
The article explains MoCRA exemptions for small cosmetic businesses with under $1 million in annual sales, exempting them from certain FDA regulations unless they deal in high-risk products like eye cosmetics or long-lasting appearance changers.