Key Lawmakers Support the FDA’s Decision to Delay Final Guidance on LDTs

Alexander Statement on FDA’s Decision to Delay Making Final Guidance on Lab-Developed Tests

“I am glad that the FDA has listened and will delay making final its current draft guidance that could have halted more than 60,000 lab-developed tests in their tracks, and will work with Congress and the new administration on next steps.” – Sen. Lamar Alexander

Read the full statement here.

Upton Comments on FDA Decision on Lab Developed Tests

“We appreciate FDA’s decision to refrain from finalizing its guidance on LDTs. It was the right call. Our committee has consistently believed that applying medical device regulations to LDTs via non-binding guidance documents is not the best approach.” – Rep. Fred Upton

Read the full statement here.

Burgess Statement on FDA’s Laboratory Developed Test Decision

“I agree with the FDA’s decision not to move forward with this guidance. 21st Century medicine should not rely on trial-and-error, and unnecessary burdensome regulation of laboratory tests could send us back to the dark ages.” – Rep. Michael Burgess

Read the full statement here.