FACT Professional Relations Encourages Cellular Therapy Stakeholders to Request Extension of Public Comment Period for FDA Proposed Rule on Laboratory Developed Tests
The FACT Professional Relations Committee, chaired by Dr. Navneet Majhail and comprised of 13 cellular therapy stakeholder organizations, has closely followed efforts to change U.S. Food and Drug Association (FDA) regulatory oversight of laboratory-developed tests. There are many such tests that patients receiving stem cell transplantation or other cellular therapies undergo. The FDA currently practices enforcement discretion for these tests but seeks to phase out the discretion approach and begin requiring approval under medical device regulations.
After years of revisions, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which was intended to achieve the above, failed to pass through Congress. Subsequently, the FDA announced a proposed rule available for public comment, titled, Medical Devices; Laboratory Developed Tests, which would phase out the discretionary approach via the regulatory process rather than via legislation. Comments are currently due by December 4, 2023.
It is important to emphasize that this proposed rule will have a major impact on transplantation and cellular therapy. It is necessary to carefully review the proposed rule and consider the effects it will have on patient safety and access to treatments. The Professional Relations Committee, in conjunction with member organizations’ individual efforts, will provide more information in the coming weeks. For now, there are two immediate needs for reviewing this proposed rule:
- Submit a request to the FDA to extend the public comment period from 60 days to 120 days. The current public comment period is only 60 days, with only 35 days left at the time of this writing, which many organizations do not feel is adequate time to fully study the impacts of this far-reaching proposed rule. Submitting a comment is relatively simple and can be done anonymously: go to https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests, click on “Submit a Formal Comment,” and complete the online form.
- Send a list of laboratory-developed tests utilized by your program to the committee. A hallmark of FACT accreditation is the integration of clinical and laboratory practices. This is a great time to put that integration to action. We encourage clinicians to meet with their laboratory colleagues at their institutions to discuss what tests the laboratories perform for their patients that are considered laboratory-developed tests. Please send those tests to Kara Wacker, Strategic Planning Administrator (kara.wacker@factglobal.org) for submission to the committee or to member organization AABB, who is leading this compilation effort, at regulatory@aabb.org.
Allowing additional time to review submitted feedback from accredited programs will help the transplantation and cellular therapy field provide the FDA with useful and relevant information to consider. Thank you for your collaboration.
