September 29, 2023
2 min read
Source/Disclosures
Disclosures:
Califf and Shuren report no relevant financial disclosures.
ADD TOPIC TO EMAIL ALERTS
Receive an email when new articles are posted on
Please provide your email address to receive an email when new articles are posted on .
”
data-action=”subscribe”>
Subscribe
We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected].
Back to Healio
Key takeaways:
- The rule would give the FDA more oversight over laboratory developed tests, which have not been regulated historically.
- The agency said it is concerned about the tests’ accuracy and performance.
The FDA proposed a rule today to start regulating laboratory developed tests to ensure test safety and effectiveness, the agency said in a press release on Friday.
In the past, the FDA has typically “exercised enforcement discretion” for the majority of laboratory developed tests (LDTs), according to the release, meaning that it “generally has not enforced applicable requirements.” However, the risks connected with the LDTs of today are much higher than those linked to LDTs that were used decades ago, the FDA said.
The FDA proposed a rule today to start regulating medical laboratory developed tests, according to a press release.
Because of this, the agency is worried some of these tests may not offer accurate results or generally perform as well as authorized tests or in compliance with the agency’s requirements. Additionally, the release noted that evidence from various sources including the FDA’s own experiences, as well as studies published in scientific literature and class action lawsuits, indicate that the situation is worsening.
“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” FDA Commissioner Robert M. Califf, MD, said in the release. “According to the CDC, 70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”
The proposed rule would alter current regulations and explicitly state that in vitro diagnostics (IVD), including LDTs, fall under the Federal Food, Drug, and Cosmetic Act. The FDA is also proposing a policy that would give the agency greater oversight of LDTs by phasing out the “general enforcement discretion approach.” After the phaseout, the FDA would expect IVD makers to meet the same applicable requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged.
“Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “It is important that these tests be held to the same standards as other tests, while helping to ensure test makers have the flexibilities they need to continue innovating and developing tests critical to the advancement of public health.”
ADD TOPIC TO EMAIL ALERTS
Receive an email when new articles are posted on
Please provide your email address to receive an email when new articles are posted on .
”
data-action=”subscribe”>
Subscribe
We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected].
Back to Healio
