Although AACC shares the Food and Drug Administration’s (FDA’s) goal of improving the safety and effectiveness of Laboratory Developed Tests (LDTs), AACC does not believe the agency’s current proposal accomplishes that goal. As such, AACC took the opportunity to comment on FDA’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” in a January 29 letter from David D. Koch, PhD, DABCC, AACC’s president.
“We recommend that the agency limit its oversight to a narrow group of high risk tests,” Koch wrote. “There appears to be a misconception that because the FDA is using its ‘enforcement discretion’ in regards to LDTs that these tests are unregulated. This belief is inaccurate.”
As it stands, LDTs are subject to a variety of oversight mechanisms at the federal and state levels and by professional accreditation organizations. “Expanding oversight to include another federal agency will, in many instances, add to the regulatory burden and costs of performing LDTs, possibly resulting in many laboratories discontinuing these tests,” Koch explained in the letter.
The FDA regulatory structure is designed for medical device manufacturers, not clinical laboratories, Koch pointed out. “Manufacturers provide invaluable test kits and instrumentation that assist laboratories in providing accurate test results. Laboratories that occasionally modify FDA cleared or approved tests do so to meet specific clinical needs,” he wrote. “The laboratory providing this service is not a medical device manufacturer, but a group of health care professionals engaging in the practice of laboratory medicine with the intent to provide safe and effective testing. The results from these tests are used by other health care providers in the care of their patients. To apply FDA regulatory requirements to all hospitals and independent laboratories utilizing LDTs would be misguided and counterproductive to excellent patient care.”
The letter also outlines AACC’s position on FDA’s proposed risk-based classification approach for determining the level of oversight for LDTs and its opinion on the current oversight process by the Centers for Medicare and Medicaid Services. “In summary, AACC believes the current regulatory structure for LDTs is adequate,” the letter concludes.
Read Koch’s letter in its entirety online.