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