The FDA has finalized a new regulation that will require makers of medical tests to show that their new offerings deliver accurate results. The goal is to ensure that tests for diseases like cancer, heart disease, and COVID-19 are safe, accurate, and reliable. The FDA Commissioner emphasized the importance of accurate tests to avoid unnecessary treatment or delays in proper care. However, the regulation will not apply to the tens of thousands of tests currently on the market, to prevent the widespread loss of access to beneficial tests.
Under the new regulation, newly developed tests that pose a high risk will need FDA approval within 3 1/2 years, while lower risk tests will have four years to obtain approval. All lab tests, both old and new, will be required to register with the FDA and report any problems or errors. This information will allow the FDA to target problematic tests and take action against them if necessary. The agency also won’t require approval for tests with no alternatives, such as those for certain rare diseases.
The FDA’s decision to regulate tests developed by laboratories is a significant move, as these tests have long been exempt from federal oversight. The agency has already been reviewing tests and kits made by medical device manufacturers, but labs, hospitals, and universities developing their own tests have been able to market them without FDA review. The testing industry has resisted additional scrutiny, arguing that it will stifle innovation and increase costs. There are estimated to be 80,000 medical tests available from 1,200 labs, covering a wide range of conditions.
The FDA has raised concerns about the accuracy of some tests, citing patients who have received inaccurate results for various conditions. Inaccurate tests can lead to incorrect diagnoses, skipped treatments, or unnecessary medication or surgery. The agency drafted tougher guidelines for the industry over a decade ago, but they were never finalized. The American Clinical Laboratory Association has expressed grave concerns about the new rule, claiming it will limit access to critical tests, increase healthcare costs, and undermine innovation in new diagnostics. The group represents large testing chains like Quest Diagnostics and LabCorp, as well as smaller labs and test makers.
Overall, the FDA’s new regulation aims to provide oversight for medical tests to ensure their accuracy and reliability. While the industry has opposed additional scrutiny, the FDA believes it is necessary to protect patients from the potential harms of inaccurate tests. By requiring registration and reporting of problems, the FDA aims to target problematic tests and take action when needed. The decision not to require approval for tests with no alternatives demonstrates a balance between oversight and accessibility. The regulation will be phased in over four years, allowing the industry time to comply with the new requirements.
