FDA Proposes End to Enforcement Discretion for Lab-Developed Tests

 The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The agency stated that active regulation of LDTs would encourage responsible innovation and resolve inconsistencies in the performance of LDTs that are currently offered for patient testing.

The FDA stated that the regulation would be amended to make explicit that IVDs fall under the definition of a medical device per the Food, Drug and Cosmetic Act (FDCA). The agency also stated that the risks associated with unregulated LDTs are much greater than in 1976, when Congress passed the Medical Device Amendments to the FDCA. Among the concerns cited in the draft rule are that modern LDTs are more reliant on advanced instrumentation and software and are more commonly used in decisions regarding patient treatment.

FDA commissioner Robert Califf said in a Sept. 29 FDA press release that 70 percent of medical decisions in the U.S. each year are dependent on the outcome of test results, and that the accuracy of these tests is consequently of the utmost importance. The agency would require clinical labs to meet the same regulatory requirements as manufacturers of IVD test kits unless the requirements of the Clinical Laboratory Improvement Amendments (CLIA) can be leveraged as a substitute.

The FDA proposes to end enforcement discretion for LDTs in five stages, beginning with a phase-out of discretion for reports of corrections and removals a year after the agency releases the final phase-out policy. Medical device reporting requirements would be in force at this point as well. Stage 2 would be completed after two years, which would end discretion regarding a variety of requirements such as facility registration, product listing, and labeling requirements. The requirements of the Quality System Regulation would be in force at the end of the third stage, or year three.

In stage 4, premarket review requirements would be reinstituted for high-risk IVDs, but this requirement would not commence prior to Oct. 1, 2027, the beginning of the 2028 federal fiscal year. Manufacturers would be required to file premarket applications for class II tests starting April 1, 2028, the same date by which registration requirements for class I tests would also be effective. The FDA stated that the date by which premarket filing requirements for class III IVDs would go into effect coincides with the beginning of the next medical device user fee program. Class III tests that are already on the market would be allowed to remain on the market while the agency reviews the associated PMA filing to avoid any shortages of tests.

The FDA stated that the third-party review program may be useful in processing the applications that will be required because of this policy. Both clinical labs and third-party review organizations will find the third-party review program useful, and the agency stated that some organizations that already take part in the CLIA certification process may be interested in serving as a third party for IVD premarket reviews.

There is some prospect that Congress will pass legislation that would significantly amend the FDA’s authority to regulate LDTs, the Verifying Accurate and Leading-edge IVCT Development (VALID) Act. Two members of the House of Representatives called for passage of the legislation in an Oct. 4 statement, although budgetary considerations may hinder any hopes of passage of the VALID Act.

A Sept. 29 press release by the Advanced Medical Technology Association (AdvaMed) gave support to the deployment of single regulatory framework for all IVDs regardless of their origin. AdvaMed CEO Scott Whitaker stated that the organization will review the proposed rule, but recommended that Congress pass the VALID Act, which would provide the FDA with a regulatory framework that is tailored to modern IVD technologies. Whitaker said the VALID Act would foster development of and access to reliable and advanced IVDs, which would significantly advance the state of personalized medicine in the U.S.