AMA Questions FDA’s Lab Test Authority
Responding to an FDA draft guidance on use of standards in agency regulatory oversight of next generation sequencing-based in vitro diagnostics used for diagnosing germline diseases, the American Medical Association (AMA) reiterates its assertion that FDA lacks statutory authority to regulate any laboratory-developed tests, including those at issue, because their development and use constitute the practice of medicine. AMA also contends that any needed regulatory oversight lies with the Centers for Medicare and Medicaid Services, which administers the Clinical Laboratory Improvement Act (CLIA).
The letter says that many proposals in the draft guidance are similar to activities that laboratories carry out as part of CLIA certification or deemed authority accreditation and it expresses concern that a duplicative regulatory approach would be burdensome for doctors and laboratories, resulting in reduced access and higher patient costs.
AMA also asks FDA to harmonize this guidance with other guidances on laboratory-developed tests and to recognize that some other organizations already have developed standards that apply to next generation sequencing tests.
In its response, the Association for Molecular Pathology (AMP) says there is a need to modernize the agency’s approach to regulating in vitro diagnostic test kits that are manufactured and sold to laboratories. The modernization, it says, would include development of more consistent and predictable regulatory pathways, with reasonable requirements that are appropriate to the context in which a test is generally used.
“FDA would be a welcome partner in helping us craft rigorous yet flexible guidelines and standards that laboratories, professional societies, and established oversight and accreditation programs for clinical laboratories could adopt to achieve high quality performance of NGS assays for the benefit of patients,” the association says. “However, AMP believes that these standards are best established through the professional associations’ development of practice guidelines.”
AdvaMedDx, the division of AdvaMed that represents producers of in vitro diagnostic tests, says it appreciates FDA’s focus on optimizing regulatory oversight for NGS tests to help accelerate research and the clinical adoption of precision medicine. The association says it endorses a standards-based approach and believes that expert standards organizations that have access to a wide range of experts and interested parties and a history of timely and effective standards development are well-placed to develop such standards.
“We appreciate that this draft guidance outlines considerations for potential classification of certain NGS-based tests for germline diseases in Class 2 as well as exemption from premarket notification requirements by relying on conformity with recognized standards to support analytical validity,” the group says. “We believe that this approach places a suitable emphasis on the importance of standards for device evaluation. FDA should extend wider application of the concepts embodied in the draft guidance to other in vitro diagnostic test technologies. Examples of other appropriately applicable technologies would include polymerase chain reaction, single nucleotide polymorphism, mass spectrometry, and microarray technologies, among others.”