IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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number of laboratories began to ofer diagnostic tests directly to consumers. Partly in response to congressional oversight hearings, FDA wrote letters—primarily of the "it has come to our attention" variety—to some of these laboratories. Again, FDA's assertion of jurisdiction over laboratories as devices undergirded these actions. No formal enforcement action was initiated by FDA against these laboratories, and no court ruled on FDA's assertion of authority over them. While the letters to "direct access" laboratories were generally viewed as dealing only with the narrow segment of laboratories serving consumers, FDA's announcement in June 2010 that it was convening a public meeting to discuss a framework for laboratory regulation was perceived—and correctly so—as potentially portending a much more fundamental policy shift. In holding the meeting, FDA articulated the reasons why regulation of LDTs was necessary.6 Among other factors, FDA cited the increasing complexity of LDTs, their clinical importance, and the change in the laboratory industry, e.g., tests conducted for patients and doctors at more remote locations. FDA said that the regulatory structure should be risk-based, and that the agency intended to exercise enforcement discretion for lower-risk tests; the adequacy of LDT validation was also a concern. FDA's proposal elicited many negative comments, ranging from the practical to the legal. Tere were numerous concerns, for example, as to the impact of FDA regulation on innovation, the ability to modify assays over time (laboratory tests can be freely changed, whereas 510(k)s and supplements to premarket approval applications (PMAs) are not conducive to product updates), and costs. Tere were also concerns expressed over how to defne the subset of tests that would be regulated. If only "high risk" tests are to be regulated, it becomes critical for FDA and companies to know which tests fall on which side of the line. After the meeting, FDA ofcials worked on developing a proposal. Te question of what FDA would do raised concerns in the laboratory industry, and led laboratories to seek legislative relief. As a result of legislation adopted last year, any proposal would need to go to the House and Senate at least 60 days before FDA issues a draft or fnal guidance related to FDA oversight of LDTs. Te question of whether FDA should regulate LDTs burst to the fore again with a speech by Commissioner Margaret Hamburg to the American Society for Clinical Oncology on June 2, 2013. In her speech, Dr. Hamburg echoed the concerns previously expressed in connection with the 2010 meeting. For example, Dr. Hamburg stated that unlike LDTs in the past, which, "were relatively simple, low-risk tests on a few patients being evaluated by physicians at the same facility as the lab, today's LDTs are more sophisticated and complex." I VD T EC H N O LO G Y | FALL 2 0 1 3 1 1 magenta cyan yellow black ES320555_IV1309_011.pgs 09.19.2013 01:55 UBM

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