Dive Brief:

• The Food and Drug Administration on Monday released a final rule strengthening its authority over laboratory developed tests, or LDTs, advancing a policy that has drawn fierce opposition from healthcare industry groups.
• The rule amends agency regulations to make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the diagnostic is a laboratory.
• The FDA said it will phase out its enforcement discretion approach for LDTs so that in vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement policy as other tests.

Dive Insight:

Critics argue the FDA’s plan to increase oversight of LDTs will slow development of cutting-edge diagnostics. Under the new rule, most LDTs would be regulated as medical devices, subject to pre-market review as other in vitro diagnostics are now, which can be a more expensive and longer process.

The FDA asserts the risks associated with LDTs have increased as the tests have become more complex and widely used, necessitating greater scrutiny to ensure their accuracy and safeguard patients.

“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

LDTs are in vitro diagnostics that are used within a single clinical laboratory, traditionally a hospital or academic medical center, though larger companies increasingly are marketing such tests.

Under the current regulatory framework, LDTs are certified under the Clinical Laboratory Improvement Amendments of 1988, and the Centers for Medicare and Medicaid Services regulates that process.

“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 Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” said FDA Commissioner Robert Califf.

The American Clinical Laboratory Association, which has spearheaded opposition to the FDA rule, maintains that LDTs are not medical devices, and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine.

“We are disappointed that FDA has continued down this path,” ACLA President Susan Van Meter said in a statement. “The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.”

Quest Diagnostics CEO Jim Davis, on an earnings call earlier this month, said the FDA’s plan to regulate LDTs raises “serious” legal issues.

“While we will be prepared to comply with the rule, we will continue to work with our trade association, ACLA, on potential next steps,” said Davis.