Scores of Critical Lab Tests Fall Into a Regulatory Void. The FDA Is Trying to Close It.
ProPublicaJUL 2023
Unregulated laboratory-developed tests, which have long skirted FDA oversight, pose a growing risk to patients because of potentially inaccurate results. The proposed rule would end decades of regulatory ambiguity and ensure the tests are safe, accurate, and reliable.
Before it tries to close the so-called loophole that has allowed laboratory-developed tests to bypass oversight for decades, the FDA must prove it has the authority to regulate these tests and examine the potential impact of its proposed regulation on the diagnostic industry.