In a news release on November 15th (here), the FDA announced that ”the U.S. Department of Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). This action will help ensure that COVID-19 tests are accurate and reliable.”
The Trump policy was a misguided effort (possibly with good intentions) to get more tests, particularly for COVID-19, into the marketplace. Clearly, the cornerstone of a test’s worth is its accuracy and reliability. Allowing firms to go to market with no FDA oversight clearly placed the public at danger due to potential false negative or false positive results. While all tests may have some degree of failure (usually under 1‑2%), just think of the magnitude of impact on the public if the failure rate of a COVID‑19 test was 50%. Understanding the usefulness of a test must be assessed prior to its marketing when the outcome of an incorrect result could be tragic, especially if the test result was a false negative and the patient actually did have COVID‑19.
The FDA announcement states, “[t]o date, the FDA has authorized over 420 tests and sample collection devices that provide a wide array of test options. Since the start of the pandemic, the FDA has adapted its regulatory approach to address the public’s testing needs and has been working closely with test developers to adjust as those needs have changed. These efforts have helped increase testing capacity and broaden public access to rapid tests, including those purchased over the counter (OTC).”
Many of us in the healthcare and regulatory fields were flabbergasted when this policy was announced by the previous administration; it is great to see that science and rationality have returned to the HHS and the withdrawn policy can be viewed in the rearview mirror before additional damage occurs.