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Still on FDA's Table: IVDMIAs, Rx/Dx Co-development, 510(k) Process, Promotion of Research-Use Dx

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By Turna Ray

MOUNTAIN VIEW, Calif. – Although things are in flux at the US Food and Drug Administration, regulation of laboratory-developed tests, review of the 510(k) process, and promotion of "research-use only" devices are still on the agency's agenda, according to the head of personalized medicine at FDA's diagnostics review division.

Speaking at the Personalized Medicine World Conference here this week, Elizabeth Mansfield, director of personalized medicine at the Office of In Vitro Diagnostic Evaluation in FDA's Center for Devices and Radiological Health, acknowledged that "things are changing hugely" at the agency.

Amid changing personnel and new divisional mandates, CDRH will continue to take a "broader look at LDT regulations" based on the recommendations of the HHS Secretary's Advisory Committee for Genetics, Health, and Society and a Citizen Petition from Genentech in 2008.

In response to audience questions, Mansfield explained that the FDA considers LDTs devices, not services, even though the agency has historically practiced enforcement discretion over the majority of such tests, leaving the Centers for Medicare and Medicaid Services to regulate such tests under the Clinical Laboratory Improvement Amendment.

However, the agency caused controversy among device makers several years ago in deciding to regulate a more complex subset of LDTs — so called in vitro diagnostic multivariate index assays. The agency has held a public hearing and issued two draft guidances with regard to IVDMIA regulation. However, due to increasing objections to these efforts, the agency has said it plans to start over with regard to IVDMIA regulation [see PGx Reporter 08-12-2009].

The "IVDMIA guidance is still on the table," Mansfield said at the meeting.

In deciding to regulate certain LDTs, FDA is not trying to say that all these tests are "bad tests," Mansfield said. "The point is that … we know that some of these tests are bad and there is no oversight. There is no way to get adverse events; there is no way to recall. There are all kinds of issues."

The FDA is planning to look at LDT regulation over the next year. "We want to see what we need to do. Do we need to do anything? How much do we need to do? Who do we need to look at? Who don't we need to look at?" she added.

Additionally the agency has also renewed its effort to issue guidelines on drug/diagnostic co-development. "We'll have a guidance out on that some time before I retire," Mansfield quipped.

Recognizing that the field of pharmacogenomics has rapidly advanced since the FDA's 2005 concept paper on drug/diagnostic co-development, the agency is planning to hold several public hearings and issue a series of white papers outlining the most up-to-date knowledge on the issue [see PGx Reporter 04-22-2009].

Another critical regulatory issue on FDA's plate going forward is the promotion of research-use only devices.

"We're certainly looking very carefully now at whether promotion of research-use devices for clinical diagnostics is out of control. We have a feeling that it is," Mansfield said. "Many, many, many devices that were formally labeled as analyte-specific reagents are now being sold to clinical labs labeled 'for research-use only, not for use in diagnostic procedures.'

"This is a problem for us," Mansfield stated. "So, we'll likely be making a statement on that."

The agency is also looking at whether its 510(k) pre-market clearance system needs to be amended.

After the Government Accountability Office reported earlier this year that the FDA may be clearing too many high-risk devices through the less stringent 510(k) process, the agency commissioned the Institute of Medicine to examine the strengths and weaknesses of its pre-market notification program and issue recommendations for improving the process [see PGx Reporter 09-30-2009].

"So, [the 510(k) process] is likely to change at some point in the future, because it is felt it is not working properly now," Mansfield said.

OIVD's new personalized medicine group, of which Mansfield is in charge, was launched in June 2009 with the aim of translating genomics research into clinical practice and to guide Rx/Dx product reviews between the drug and diagnostics divisions. In addition to Mansfield, there are two associate directors in this group, Zivana Tezak and Marina Kondratovich.

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