FDA’s Modernization of Cosmetics Regulation Act (MoCRA) is reshaping cosmetic labeling requirements in the United States. As new requirements take effect and additional guidance emerges, cosmetic companies must understand what information belongs on product labels and how to prepare for compliance.
Join Registrar Corp’s regulatory experts for a practical review of MoCRA labeling requirements, including recent developments and upcoming compliance considerations.
Topics include:
– New adverse event contact information requirements
– FDA actions on fragrance allergen labeling
– Bilingual labeling requirements
– Essential labeling elements for cosmetic products marketed in the U.S.
– Key compliance dates and implementation considerations
Whether you manufacture, import, or market cosmetics in the U.S., this webinar will help you understand FDA’s evolving labeling expectations and prepare your products for compliance.
About the speaker:
Adriana Schulka is a Senior Regulatory Specialist and Food Scientist with over 20 years of experience in the food and health products industry. As an expert at Registrar Corp’s Label Review team, she helps global clients navigate FDA requirements for foods, dietary supplements, cosmetics, including MoCRA, and OTC drugs. Adriana has reviewed more than 600 product labels and is known for translating complex regulations into clear, practical compliance guidance.
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 medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
