FDA labeling mistakes can derail launches—especially at the port. In this practical, compliance-first webinar, you’ll learn the two questions every company must answer before entering the U.S. market: Are my ingredients permitted? Is my labeling correct? We’ll break down FDA’s oversight of foods, how ingredients are classified (including food additives, GRAS, and color additives), and the most common formulation pitfalls that trigger detentions or refusals. Then we’ll walk through the mandatory label elements FDA expects to see—statement of identity, net quantity, ingredient list, Nutrition Facts, allergen declaration, and more—plus emerging updates like FD&C Red No. 3 timing, allergen guidance changes, the new “healthy” rule timeline, and proposed front‑of‑package (FOP) labeling. You’ll leave with a clearer way to assess label risk before shipping, reduce rework, and protect your supply chain.
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.
