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- CAP Tells FDA to Pause Change Control Plan Guidelines
With the Food and Drug Administration (FDA) planning to implement new oversight rules for laboratory-developed tests (LDTs), the CAP strongly urged the agency to delay final draft guidance entitled Predetermined Change Control Plans for Medical Devices. The CAP is concerned that the guidance, in combination with the LDT rulemaking, will result in a significant reduction in the number of highly accurate LDTs.
A Predetermined Change Control Plan is documentation developed by a test developer and submitted to the FDA to outline planned modifications and assessments of those modifications to a device. The plan is reviewed as part of premarket submission, negating the need for additional market submissions for future modifications.
The CAP noted that medical practice undergoes continuous process change because of drug development and advancements in medicine. Clinical laboratories adapt and change in parallel to support or extend clinical practice. In addition to concerns over the timing of the guidance, the CAP said it would create additional regulatory burden and uncertainty for laboratory-based developers as most clinical laboratories frequently use and modify low-risk tests to address clinical needs for their local patient populations.