- Home
- Advocacy
- Latest News and Practice Data
- Lawmakers Ask FDA to Suspend LDT Final Rule
On July 10, the House Appropriations Committee requested in legislation that the Food and Drug Administration (FDA) suspend implementation of the laboratory-developed tests final rule that went into effect May 6. The recommendations include partnering with Congress to modernize the regulation of LDTs.
Lawmakers said the FDA’s final rule is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee wants the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs. The CAP would support a delay that gives Congress time to enact legislation that restricts the FDA and focuses full oversight on tests that are highest risk to patients.
During a Capitol Hill briefing on July 9, the College of American Pathologists (CAP) discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of LDTs and allows for innovation of new technologies. CAP President Donald Karcher, MD, FCAP, and Joe Saad, MD, FCAP, President, Surgical Pathologists of Dallas spoke with congressional staff about these issues. The CAP has been diligently lobbying lawmakers for a legislative solution to LDT oversight that limits the authority of the FDA, while maintaining patient safety. Watch the briefing or listen to it as a podcast.
For additional resources visit: Laboratory-Developed Test Oversight