FDA Releases Controversial Final Rule on Laboratory Developed Tests: Your Organization-YOUR Impact

Changes to FDA’s Rule Underscores ASCP’s Advocacy—WE are here to Protect YOU

The U.S. Food and Drug Administration (FDA) has released its Final Rule claiming oversight authority over laboratory developed tests (LDTs). The rule would phase out FDA’s general “enforcement discretion” policy for LDTs over four years. When fully implemented, the FDA would require all in vitro diagnostics (IVD) to meet the Agency’s medical device requirements, except where it maintains enforcement discretion. ASCP’s review of the rule does not alter our opposition to the regulation.

While the FDA’s oversight scheme for LDTs remains largely the same as in its Proposed Rule, the Agency has made several noteworthy changes. Many of these touch on the key issues ASCP addressed in its comments opposing the rule, such as grandfathering existing tests and protecting laboratories at academic medical centers and other facilities from unnecessarily burdensome regulations. Besides submitting formal comments on the Proposed Rule, ASCP released several grassroots actions alerts, resulting in more than 1,700 comment letters being sent to the FDA and more than 6,000 letters to Congress opposing the Agency’s proposal. Given that the FDA received approximately 6,500 comments on its proposal, the concerns expressed by ASCP and its members were clearly heard by the Agency. 

The groundswell of member support for our position fueled the hard work and determination of ASCP’s American Medical Association delegation—which worked side-by-side with our Commission on Science, Technology, and Policy—to single-handedly wrestle unanimous support from the AMA House of Delegates for a resolution calling on the FDA to extend the comment period on its proposed rule. This came after ASCP’s request to FDA for an extension of the rule’s comment period was rejected.

ASCP regards the FDA’s policy changes as an important achievement, one that recognizes that LDTs require more regulatory flexibility than the Agency provides for commercial IVDs. Among the changes the FDA made in the final rule include providing limited enforcement discretion for LDTs on the market before May 6 (grandfathering) as well as those “manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system.” FDA will also generally not require tests approved by the New York State Clinical Laboratory Evaluation Program to be subject to premarket review requirements. Tests provided enforcement discretion will have to meet other FDA requirements, like medical device reporting, registration and listing requirements. 

ASCP President Robert Goulart, MD, MASCP, expressed concern about the rule: “FDA’s changes, while appreciated, do not remove our concerns that this rule—as well as the current version of the Verifying Access to Leading-edge IVCT Development Act, or VALID Act—impose significant challenges that will adversely impact the ability of clinical laboratories and laboratory professionals of all stripes to continue to innovate and provide our patients with critical testing services. ASCP will continue to oppose the rule and will partner with other similarly concerned organizations to advance patient care while maintaining the flexibility that laboratories need to continue developing quality innovative laboratory services.”