Thursday, January 25, 2024

CAP Weighs in on FDA LDT Proposal

College of American Pathologists has weighed in on the FDA LDT proposal, for which comments were submitted December 4, 2023.   Here are four of their resources:

  • Comment press release here.
  • Actual comment letter here.  10pp.
  • Opinion piece in CAP TODAY here.
  • Detailed comments from a dozen thought leaders, in CAP TODAY, here.

AI Corner:

I read CAP's letter in full and can confirm that Chat GPT4 provides a good bullet-point summary, as follows...


[begin chat gpt]

The letter from the College of American Pathologists (CAP) to the FDA, regarding the proposed rule "Medical Devices; Laboratory Developed Tests", can be summarized in bullet points as follows:

  1. Introduction: CAP's appreciation for the chance to comment on the FDA's proposed rule regarding Laboratory Developed Tests (LDTs).
  2. CAP's Role: Highlighting CAP as a leading organization in pathology and laboratory medicine, advocating for excellence in these fields.
  3. Historical Perspective: CAP's historical role in advocating for a regulatory framework that balances patient safety, quality testing, and innovation without excessive burdens.
  4. Concerns Over Proposed Rule: CAP's view that the proposed rule could significantly reduce the availability of high-quality LDTs, impacting patient care.
  5. Specific Areas of Comment: CAP's intention to offer detailed comments on various aspects of the proposed rule.
  6. Requirements for Continued Enforcement Discretion: Emphasis on certain test categories that should remain under FDA's enforcement discretion.
  7. Exempt Tests: Suggestion to exempt certain tests offered before the rule's enactment.
  8. Manual and Forensic HLA Tests: Advocacy for continued enforcement discretion for certain manual tests.
  9. LDTs Developed Locally: Recommendation for discretion in small-scale, local LDT development.
  10. Adverse Events Reporting: Support for adverse event reporting with a need for educational programs.
  11. Use of Existing Regulatory Authority: Discussion on leveraging existing frameworks and avoiding redundant regulations.
  12. Quality Systems (QS): Concerns about the duplicative nature of proposed QS controls.
  13. Corrections and Removal: Suggestion to maintain enforcement discretion for documented corrective actions.
  14. Registration and Listing Requirements: Concerns about the regulatory burden and suggestion to exempt low-risk LDTs.
  15. Labeling Requirements: Proposal for continued discretion in labeling if information is provided upon request.
  16. Regulatory Framework and Risk Classification: Discussion on the impact of FDA's regulations on clinical laboratories and LDT development.
  17. Recommendations: Calls for public hearings, extended compliance periods, and a focus on least burdensome approaches.
  18. Conclusion: CAP's overall concerns about the proposed rule stifling medical innovation and increasing regulatory burden.
  19. Final Remarks: Invitation for further discussion and contact details.

The letter comprehensively addresses CAP's concerns, suggestions, and recommendations regarding the FDA's proposed rule on LDTs.

[end chat gpt]


The grand-daddy of all  comment letters on the topic is ACLA's, here.

See American Hospital Association letter here.