Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration.

The proposed rule seeks to amend the FDA’s regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. This is when the manufacturer of the IVD is a laboratory.

The FDA is also proposing a new policy under which it intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach. However, the FDA has said this rule will not apply to all LDTs currently on the market.

FDA Commissioner, Robert M. Califf, said: “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.

“According to the Centers for Disease Control and Prevention, 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 FDA has said that it is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The organisation argued that since the Medical Device Amendments of 1976 ruling was passed, which set the initial rules for how LDTs are treated, LDTs have become more complex, can be run in large volumes for varying amounts of patients and are used for frequently for guiding healthcare decisions.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said: “Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate.

“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.”