Statement on Proposed FDA Laboratory Developed Test Rules
The FDA has proposed new rules regarding laboratory developed tests. CIS is considering the impact that these proposed rules regarding laboratory developed tests may have on diagnostic testing provided to patients with inborn errors of immunity. In an effort to address concerns, CIS will be providing a letter to the FDA during the comment period. We encourage others to consider this matter thoughtfully and supply additional feedback during the comment period. Feedback may be given using the electronic filing system at https://www.regulations.gov/document/FDA-2011-D-0357-0002. Comments must be filed before 11:59 p.m. Eastern Time at the end of December 4, 2023.
You can view the letter that CIS will be providing to the FDA here.