Scores of Critical Lab Tests Fall Into a Regulatory Void. The FDA Is Trying to Close It.
ProPublicaJun 16, 2023
The Facts
On Friday, the US Food and Drug Administration (FDA) said that it intends to step up its oversight of laboratory-developed tests to ensure their safety and effectiveness.
The proposed rule would formally bring thousands of tests performed in large laboratories under the FDA's regulatory authority.
The Spin
Pro-establishment narrative
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.
Establishment-critical narrative
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.
