MedTech Dive April 29, 2024
Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.
Dive Brief:
- The Food and Drug Administration released a final rule on Monday strengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare industry groups.
- The rule amends agency regulations to make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
- The FDA said it will phase out its enforcement discretion approach for LDTs so that in vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement policy as other tests.
Dive Insight:
Critics argue...
Today's Sponsors
Today's Sponsor