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Blog Category Section FAQ-Medical Devices
For Medical Device Establishments, who must register? Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee. What information is submitted for medical device establishment registration? In addition to registering with FDA, most owners or operators of
Read more »Blog Category Section FAQ-Drugs
For Drug Establishments, who must register? Domestic or foreign owners or operators of establishments that manufacture, prepare, propagate, compound, or process a drug or drugs and are not considered exempt must register their facility with FDA, according to the Code of Federal Regulations. In general, exemptions include pharmacies, professional licensed practitioners, researchers, teachers, analysts, and
Read more »Blog Category Section FAQ-Food Beverage
Who needs to register with FDA? Any domestic or foreign facility that intends to produce and distribute the following products for the U.S. market must register with FDA: Food, beverages, or dietary supplements Cosmetics Animal and veterinary products Medical devices Drugs products (including OTC) Tobacco products Radiation-emitting devices (RED) Biologics How often do I need
Read more »Blog Category Section FAQ-Cosmetics
What is MoCRA? MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84 years and establishes many new requirements, such as: Facility Registration Product Listings Good Manufacturing Practices (GMPs) Safety Substantiation
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