FDA issues final rule applying medical device rules to laboratory developed tests
The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion approach for most laboratory developed tests over four years, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro diagnostic products. The final rule amends FDA regulations to make explicit that IVD products, which include laboratory developed tests, are devices under the Federal Food, Drug, and Cosmetic Act. After the four years, the agency would require all IVD makers to meet the same applicable device requirements, except where FDA has decided to apply enforcement discretion for certain device rules, such as those for premarket requirements and quality systems. The rule takes effect 60 days after publication in the May 6 Federal Register.
AHA had urged (the FDA not to apply the proposed rule to hospital and health system laboratory developed tests. In the final rule, FDA said it intends to exercise limited enforcement discretion for certain categories of IVDs, including LDTs developed and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system, currently marketed LDTs that were first marketed prior to the date of issuance of the final rule, and LDTs approved by the New York State’s Clinical Laboratory Evaluation Program. In addition, the agency released draft guidance on the rule’s enforcement discretion policy during an infectious disease outbreak or public health emergency.
"We appreciate that the FDA has recognized the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care," said Stacey Hughes, AHA executive vice president. "The enforcement discretion in this final rule is of particular importance. We also welcome the agency’s attention to the gaps in FDA-authorized commercially available tests in meeting certain patient needs, such as for rare diseases or conditions. The FDA’s decision to apply limited enforcement discretion for currently marketed laboratory-developed tests rightly recognized that applying the full scope of its device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely.
"However, we remain concerned that many vital tests developed in hospitals and health systems may be subjected to unnecessary and costly paperwork, especially as certain FDA device requirements are phased in over the next four years. As a result, this will cause a substantial reduction in patient access to innovative and targeted diagnostic tests. We will continue to evaluate the rule closely and work with the FDA."
AHA members will receive a Special Bulletin with additional information about the final rule.