The FDA finalized a rule April 29 to treat laboratory-developed tests as medical devices, putting them in the purview of federal oversight.
Under the new rules, the FDA will phase in oversight of laboratory-developed tests, or LDTs over a four-year period. LDTs are those designed, manufactured and used within a single clinical laboratory, often in hospital and academic medical center labs.
"LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person's risk of cancer, or aid in diagnosing heart disease and Alzehiemer's," Robert Califf, MD, FDA commissioner, said in a news release. "The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and healthcare providers can trust."
Last fall, the FDA issued a proposed rule on the matter, which the American Hospital Association opposed, saying the move would negatively affect patients' access, stifle innovation and potentially increase hospital costs. In finalizing the rule April 29, federal regulators said they considered a large volume of comments they received on the proposed rule and have made adjustments "in a manner that better serves public health."
Per the final rule, the FDA will give enforcement discretion to tests that are currently on the market, essentially grandfathering them into approval — a decision the agency said "is intended to address the risk that the perceived costs of compliance with such requirements could lead to the widespread loss of access" to tests patients currently rely on.
The FDA will also give enforcement discretion to those manufactured and performed by a lab within a healthcare system "to meet an unmet need of patients receiving care within the same healthcare system when an FDA-authorized test is not available."
Newly developed tests that pose a high risk (those for life-threatening disease), would need to be approved within three and a half years, while lower risks tests will have four years.
The American Hospital Association said it "appreciates" the enforcement discretion laid out in the final rule.
"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," Stacey Hughes, executive vice president of the AHA, said in a statement.
"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."
In a statement, the American Clinical Laboratory Association — a national trade group that represents laboratories including Quest Diagnostics and Labcorp — said it has "grave concerns" about the rule, claiming it will "limit access to scores of critical tests, increase healthcare costs, and undermine innovation in new diagnostics." The group also argued the new rules exceed the FDA's statuatory authority.
Some industry analysts anticipate opponents to sue the FDA in an effort to keep the rules from going into effect, according to The Washington Post.