Understanding FDA Master Files (MFs) is critical for companies preparing regulatory submissions that depend on confidential or proprietary information. This webinar delivers a clear, practical overview of how FDA Master Files operate, who relies on them, and how they support regulatory applications across the drug, biologic, medical device, food, and tobacco industries.
Attendees will gain insight into the various Master File types, the documentation typically required, and how the FDA reviews and utilizes these files during application assessments. We will break down fee structures and submission processes—particularly under GDUFA requirements—and explain key administrative considerations that can impact timelines and compliance.
The session will also explore electronic submission formats such as eCTD, ESG NextGen, and other commonly used platforms, along with best practices for maintaining an active Master File through annual reports, Letters of Authorization, and ongoing updates. Common challenges faced by Master File holders and applicants will be addressed, with practical guidance on how to avoid delays and regulatory setbacks.
Whether you are new to Master Files or seeking to strengthen your current approach, this webinar will provide actionable insights to help you navigate FDA requirements confidently and support efficient, compliant submissions.
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.
