FDA Compliance Expectations Are Changing. Is Your Facility Prepared?

June 3, 2026 by Sonal Gadekar

For pharmaceutical manufacturers, FDA compliance challenges often become visible only after they begin disrupting operations, delaying product commercialization, increasing regulatory exposure, or creating unexpected financial obligations.

Inaccurate establishment registrations, missed reporting deadlines, or gaps in understanding GDUFA and OMUFA requirements can lead to avoidable compliance risks, facility fee complications, import delays, heightened FDA scrutiny, and, in some cases, product detentions. As regulatory expectations continue to evolve, maintaining a proactive and well-structured compliance strategy is essential for protecting market access and supporting uninterrupted business operations.

Join our regulatory experts for a practical webinar designed to help pharmaceutical manufacturers better understand key FDA regulatory requirements tied to registration, reporting, user fee programs, and emerging enforcement trends. Attendees will gain insight into current obligations, submission expectations, common compliance gaps, and recent detention patterns observed by industry this year.

What We’ll Cover:

– Establishment registration and product listing requirements

– CARES Act amount reporting obligations

– GDUFA self-identification and facility/user fee requirements

– OMUFA facility fee considerations

– Submission timelines, recordkeeping, and documentation expectations

– Common FDA detention scenarios and recent enforcement trends observed this year

The session will conclude with a live Q&A session, providing attendees the opportunity to discuss specific compliance questions directly with our experts.

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.

For Medical Device Establishments, who must register?

What information is submitted for medical device establishment registration?

Who must provide medical device listings?

What information is submitted for a medical device listing?

What is a master file?

Subscribe To Our News Feed