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.
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Washington State proposes new rule to restrict formaldehyde in cosmetic products
Washington State proposes a rule to restrict formaldehyde and FRAs in cosmetics. Learn about the potential impact.
Washington State introduces interim policy on lead in cosmetics
Discover the effects of non-compliance with the Modernization of Cosmetics Regulations Act of the FDA to your business and market access.
What are FDA measures in case of MoCRA non-compliance and what it means for your business?
Discover the effects of non-compliance with the Modernization of Cosmetics Regulations Act of the FDA to your business and market access.
Selling cosmetics in California: Obelis can assist with reporting
Navigate California’s strict cosmetic regulations with Obelis’ assistance in meeting local reporting requirements under CSCA and CFFIRKA.
MoCRA exemptions for small businesses explained
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.
Cosmetics Direct: the FDA portal for cosmetics registrations
MoCRA establishes registration and listing requirements for manufacturing facilities and cosmetic products. Facility registration and…
Everything you need to know about adverse events under MoCRA
MoCRA has significantly changed the regulatory framework of cosmetic products in the United States. Among…
What is the role of the FDA on cosmetics?
The Food and Drug Administration (FDA) is a federal agency regulating several products, such as…
FDA: Delayed enforcement of MoCRA registration requirements, however, many other obligations remain (Dec 2023)!
On November 8, 2023, the FDA officially announced that they will not enforce MoCRA requirements…