FDA Device Official Says Final Guidance On Lab-Developed Tests Unlikely in 2015

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By Michael D. Williamson

May 5 — The Food and Drug Administration might not issue in 2015 the final version of guidance documents putting laboratory-developed tests under the agency’s regulatory authority, an FDA official told a clinical lab industry group May 5.

Elizabeth Mansfield, director of personalized medicine at the FDA's Center for Devices and Radiological Health, told the American Clinical Laboratory Association's annual meeting the final version of 2014 draft guidance documents likely won't be issued in 2015 because of the need for multiple reviews. She didn't say when the final guidance documents would be issued.

Also at the ACLA's meeting, Centers for Medicare & Medicaid Services official Marc Hartstein said the agency likely will miss a June 30 deadline for issuing a rule about how it will collect market data and set new rates for Medicare payment of clinical labs. Hartstein, director of the CMS's Hospital and Ambulatory Policy Group, said the Protecting Access to Medicare Act (PAMA) of 2014 set the June 30 deadline.

Impact of CMS Rule Delay 

The likely delay would “significantly compress an already tight time frame for laboratories to prepare and submit data to CMS,” Julie Khani, an ACLA senior vice president, told Bloomberg BNA in a May 5 e-mail. In addition, Hartstein’s remarks acknowledged that “PAMA implementation will be complex and challenging for both labs and for CMS,” she said.

The ACLA remains strongly committed to working with the CMS, as well as Congress and other stakeholders, on successful PAMA implementation “that results in reimbursement that reflects the broad scope of the market, recognizes the value of laboratory services, and protects access for Medicare beneficiaries,” Khani said.

Existing LDTs Exempt?

Mansfield also discussed changes the FDA may make to the final guidance documents on lab tests. For example, the FDA is considering exempting some existing laboratory-developed tests (LDTs) from agency oversight outlined in the 2014 guidance documents, Mansfield said.

In comments on the draft guidance documents, stakeholders told the agency it should grandfather some existing LDTs into the agency's new oversight framework, she said, adding that the FDA “is taking that into consideration.”

Currently, LDTs are regulated by the CMS under the Clinical Laboratory Improvement Amendments, while the FDA regulates diagnostic tests only if they are developed and sold by device manufacturers as diagnostic kits.

In the fall of 2014, the FDA issued draft guidance on a framework for agency oversight of LDTs (Docket No. FDA-2011-D-0360) and a separate draft guidance on medical device reporting for LDTs (Docket No. FDA-2011-D-0357). 

Comments were due Feb. 2 on the draft guidances, with clinical labs strongly opposing the change, but with device manufacturers generally supporting the FDA's approach.

In the background information of the oversight framework guidance, the FDA said that in vitro diagnostic tests (IVDs), which include LDTs, meet the definition of medical devices, so the agency has authority to regulate LDTs under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. LDTs are IVDs intended for clinical use that are designed, manufactured and used within a single laboratory.

The guidance said the FDA decided to exercise “enforcement discretion” over LDTs because in 1976, LDTs were manufactured in small volumes by local laboratories and were similar to well-characterized, standard diagnostic devices. Today, the guidance said, the landscape for LDTs has changed dramatically, with LDTs frequently being manufactured by large corporations with components and instruments that aren't legally marketed for clinical use.

To contact the reporter on this story: Michael D. Williamson in Washington at mwilliamson@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

A website for the ACLA conference is at http://www.acla.com/about-us/annual-conference/.