FDA Expands CDRH Learn With New UDI and Biocompatibility Training Modules

The U.S. Food and Drug Administration (FDA) has expanded its CDRH Learn educational platform with new training resources for the medical device industry.

CDRH Learn is the FDA Center for Devices and Radiological Health’s multimedia educational resource covering medical device and radiation-emitting product laws, regulations, guidances and policies across the product lifecycle. Materials are provided through formats including presentations, videos, audio recordings and printable slides. 1791521213425

Among the latest additions are new modules focused on Unique Device Identification (UDI) and biocompatibility chemical analysis, both identified as new modules dated 6 October 2026.

New Unique Device Identification Module

FDA has added a new Unique Device Identification (UDI) System – Regulatory Overview module to CDRH Learn.

The resource is identified as a new module dated 6 October 2026 and includes a presentation, printable slides and a transcript. 1791521213425

The UDI section of CDRH Learn also includes resources addressing topics such as:

• Global Unique Device Identification Database (GUDID);

• GUDID account preparation;

• Device Identifier records;

• GUDID submission options;

• data quality;

• direct marking requirements.

These resources provide manufacturers and regulatory professionals with a structured educational pathway for understanding FDA’s UDI ecosystem.

Why UDI Remains Important

UDI supports medical device identification and traceability throughout the U.S. healthcare and regulatory system.

For manufacturers, correct UDI implementation can affect multiple regulatory and operational activities, including:

• device identification;

• registration and listing;

• GUDID submissions;

• labelling;

• traceability;

• post-market activities.

The addition of a dedicated regulatory overview module provides industry with a consolidated FDA training resource for understanding the framework.

New Biocompatibility Module

FDA has also added a new CDRH Learn module titled “Extractions for Conducting Chemical Analysis for Biocompatibility Assessment.”

The resource is identified as a new module dated 6 October 2026 and includes a presentation, printable slides and transcript. 1791521213425

The topic relates directly to chemical characterization and extraction methodologies used as part of medical device biocompatibility assessment.

Relationship With ISO 10993

The biocompatibility section of CDRH Learn also provides educational materials covering FDA’s approach to ISO 10993-1, including biological evaluation of medical devices within a risk management process. 1791521213425

The new extraction-focused module complements these existing resources by addressing a more specific element of chemical analysis used in biological evaluation.

For manufacturers, this is particularly relevant where chemical characterization forms part of the evidence used to support biological safety.

Broader CDRH Learn Resources

The updated CDRH Learn platform covers a wide range of regulatory topics across the medical device lifecycle.

These include:

• 510(k);

• De Novo;

• IDE;

• PMA;

• Q-Submissions;

• consensus standards;

• device classification;

• Quality Management System Regulation;

• medical device reporting;

• recalls;

• IVDs;

• digital health;

• cybersecurity;

• UDI;

• biocompatibility.

FDA describes CDRH Learn as a comprehensive and accessible resource intended to support industry education across the full medical device lifecycle. 1791521213425

Other 2026 Educational Updates

The CDRH Learn page also shows several other modules added or updated during 2026.

Examples include:

• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices — new module dated 26 February 2026; 1791521213425

• Medical Device Risk-Based Inspections — new module dated 14 April 2026; 1791521213425

• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle — new module dated 15 May 2026; 1791521213425

• Clinical Decision Support Software, Final Guidance — new module dated 13 March 2026. 1791521213425

The page also includes a Medical Device Development Tools module added in September 2026, showing FDA’s continued expansion of its regulatory education materials.

Impact on Medical Device Manufacturers

For manufacturers and regulatory professionals, the latest CDRH Learn additions provide practical FDA resources for two important compliance areas.

The new UDI Regulatory Overview can support teams responsible for:

• UDI implementation;

• GUDID submissions;

• device identification;

• regulatory data management;

• labelling and traceability.

The new biocompatibility extraction module is particularly relevant for teams working on:

• biological evaluation;

• chemical characterization;

• extraction strategies;

• ISO 10993 activities;

• premarket submissions.

Together, the additions reinforce FDA’s use of CDRH Learn as a central training resource for regulatory requirements and technical expectations throughout the medical device lifecycle.