FDA 2026 Regulatory Outlook: Inspection Trends, AI Targeting & Global Compliance Priorities for Food Companies

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U.S. FDA oversight continues to evolve toward a more data-driven, risk-based model — and 2026 will reflect deeper scrutiny in areas that directly affect both U.S. importers and foreign food manufacturers. 

Inspection data shows sustained focus on FSVP compliance, with food safety plan and hazard analysis deficiencies among the most frequently cited findings. GMP fundamentals — including sanitation, personnel practices, and operational controls — remain a core inspection priority. In higher-risk categories such as seafood, FDA is also increasing attention on HACCP implementation and execution. 

At the same time, FDA’s adoption of AI-based risk targeting is influencing how facilities are prioritized for inspection, using factors such as product risk, compliance history, recall data, and time since last review. For foreign suppliers, importer compliance increasingly serves as FDA’s window into your operations — even in the absence of a physical inspection. 

In this 2026 outlook session, our experts will review: 

  • Emerging FSVP inspection trends and what they signal 
  • Hazard analysis and food safety plan expectations 
  • Persistent GMP observations and how to address them proactively 
  • HACCP implementation trends in higher-risk sectors 
  • How AI-driven targeting is shaping inspection selection 

Whether you are a U.S. importer or a manufacturer supplying the American market, this webinar will provide insight into FDA’s current direction and practical considerations to help maintain compliance and protect market access in the year ahead. 

About the speakers
Fabiola Negrón is the Director of Food Safety at Registrar Corp. She has been featured in interviews and has written articles for numerous food safety trade publications. Fabiola oversees Registrar Corp’s regulatory specialists that assist domestic and foreign food facilities and U.S. importers with U.S. FDA food safety compliance.   

Larry Stringer is a nationally recognized food safety expert who spent more than 30 years at the U.S. FDA. He led the development of FDA’s Food Safety Culture training for field and headquarters staff and now serves as an independent contractor with Registrar Corp.  

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:

  1. Contract Manufacturer
  2. Contract Sterilizer
  3. Foreign Exporter
  4. Manufacturer
  5. Relabeler / Repackager
  6. Remanufacturer
  7. Reprocessor of Single Use Device
  8. Specification Developer
  9. 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.

  1. Company function (activity)
  2. Device product code
  3. Proprietary names
  4. 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.

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