FDA Cannot Regulate Laboratory-Developed Testing Services as Devices, Counsel for Association Argue

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

FDA Cannot Regulate Laboratory-Developed Testing Services as Devices, Counsel for Association Argue

Dennis Tosh

Guide to Medical Device Regulation

January 14, 2015 at 10:38 AM EST

Pushing back against the FDA’s recent moves to regulate laboratory-developed tests (LDTs), a trade association representing clinical laboratories Jan. 7 released a white paper by two veteran advocates asserting that the tests are not medical devices and thus cannot come under the agency’s authority. The 25-page white paper, drafted by former Solicitor General Paul D. Clement ... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

FDA Cannot Regulate Laboratory-Developed Testing Services as Devices, Counsel for Association Argue

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT