The Generic Drug User Fee Amendments (GDUFA) are central to FDA oversight of generic drug manufacturers, but navigating the requirements isn’t always straightforward. Self-identification, program fees, and DMF submissions create recurring challenges that can be costly if misunderstood or overlooked.
In this session, Melissa Sayers, Drug Regulatory Manager, will simplify the complexities of GDUFA and provide practical guidance to help you stay ahead of FDA requirements.
You’ll walk away with a clear understanding of:
- Who must self-identify with FDA—and how this information is used to determine annual program fee obligations
- The structure of GDUFA program fees—including annual facility fees, ANDA holder program fees, and Drug Master File (DMF) fees
- How FDA assesses these fees and the impact on your business operations
- Key compliance considerations under GDUFA III that can help you anticipate obligations and avoid costly missteps
This focused webinar will equip manufacturers, DMF holders, and regulatory professionals to manage costs strategically, strengthen compliance, and ensure smooth market entry under GDUFA.
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.
