Advocacy Update

December 10, 2024

In this Issue:

FDA Publishes Guidance for AI Premarket Submissions

The FDA published guidance for premarket submission of artificial intelligence/machine learning (AI/ML) medical software on December 3. The guidance details information manufacturers should include in an FDA premarket submission so that they can alter their AI/ML software over time without needing to complete another FDA marketing submission.

In a June 2023 letter, the CAP supported concepts proposed within the initial draft guidance. The letter requested transparency in labeling so pathologists and other physicians have useful information from manufacturers to oversee the implementation and monitor performance of that AI/ML software. Read the CAP’s June 2023 comments to the FDA.

The FDA stated that it revised definitions of the terms “artificial intelligence” and “machine learning” to align with an executive order from October 2023.

Review the FDA final guidance.

FDA Discusses Registration and Listing Rules for LDTs

On December 3, the FDA led a webinar reviewing compliance for its registration and device listing requirements for laboratory-developed tests (LDTs). These requirements are part of stage 2 of the FDA LDT oversight regulation and take effect May 2026. Stage 1 requirements take effect May 6, 2025.

The CAP had previously urged the FDA to provide more education about the agency’s process for registration and listing how the process would apply to LDTs.

Review the FDA webinar slides and webpage.

Register for LDT Webinar, January 9: Ready Your Laboratory for the FDA's Stage 1: Corrective Action and Removal Reporting

Join the CAP on Thursday, January 9, at 12:00 PM CT/1:00 PM ET for the third webinar in a series about laboratory-developed tests. Learn the steps to comply with the FDA requirements for corrective action and removal reporting specific to laboratory-developed tests.

Speakers will provide context relevant to laboratories and share practical solutions. Presenters are Council on Scientific Affairs Chair Bobbi Pritt, MD, FCAP; Council on Accreditation Chair Earle S. Collum, MD, FCAP; and Deeona R. Gaskin, JD, MPH, from the law firm Sidley Austin.

Register online

Hung S. Luu, MD, PharmD, FCAP, Reappointed to Federal Health Information Technology Committee

The Government Accountability Office (GAO) recently reappointed Hung S. Luu, MD, PharmD, FCAP, to the Health Information Technology Advisory Committee (HITAC) for a second term. Dr. Luu was first appointed to the HITAC in 2022.

HITAC advises the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP, formerly known as ONC) on policies, standards, implementation specifications, and certification criteria for implementing health information technology infrastructures that advance the electronic access, exchange, and use of health information.

Dr. Luu is chair of the CAP Informatics Committee. He is the Director of Clinical Pathology at Children’s Health, a health system with hospitals in Plano and Dallas, Texas. Dr. Luu also is an Associate Professor of Pathology at the University of Texas Southwestern Medical Center. He serves as the co-chair of the implementation committee for the Food and Drug Administration’s Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) initiative, a multi-stakeholder initiative to improve laboratory data quality, interoperability, and portability.

Congress Sets 2025 Legislative Calendar

Congress will be in session when pathologists participate in the CAP’s annual Hill Day on April 29. Hill Day is part of the CAP House of Delegates and Pathologists Leadership Summit April 26-29 in Washington, DC.

Senate and House lawmakers have released schedules for next year. You can review those by clicking these links:

ICYMI: What Will Be the Impact of the Final 2025 Fee Schedule on Your Practice?

Did you miss the CAP’s What Will Be the Impact of the Final 2025 Fee Schedule on Your Practice webinar? Watch the on-demand recording featuring presentations from Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bocsi DO, FCAP.

CAP experts explain the final regulations that will impact Medicare payment for services and pathologists' participation in the quality initiatives.

View the presentation