The US Food and Drug Administration (FDA) will not extend the comment period deadline for a proposed rule that would start phasing out its regulatory discretion of laboratory-developed tests (LDT).
Extending the comment period would have potentially delayed the implementation of the rule while giving Congress more time to pass diagnostic reform legislation. Stakeholders had expected FDA to extend the comment deadline, but on 31 October, the agency announced it would move forward with the original timeline.
“After considering the requests and other factors, including the extensive background of public comment on this topic and the public health benefits of proceeding expeditiously, the FDA has determined to proceed with the standard 60-day comment period,” the agency said in a statement on its website. “As stated in the notice of proposed rulemaking, comments on the proposed rule must be submitted to the docket by December 4, 2023, in accordance with the procedures described in the notice.”…
