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IVD POLICY WILL NOT INCLUDE EXEMPTIONS FOR "STANDARD-OF-CARE" TESTS

This article was originally published in The Gray Sheet

Executive Summary

IVD POLICY WILL NOT INCLUDE EXEMPTIONS FOR "STANDARD-OF-CARE" TESTS, Ronald Johnson, director of the Office of Compliance in FDA's Center for Devices and Radiological Health, said at an Oct. 6 session of the Regulatory Affairs Professionals Society annual meeting. Johnson explained that "there will be no accommodation list" of standard-of-care tests in a pending final compliance policy guide (CPG) that will outline FDA's strategy for dealing with inappropriate commercialization of in vitro diagnostic tests labeled for research or investigational use. In previous drafts of the CPG, the accommodation list included 59 tests that would have been exempt from a certification program designed to ensure that that research or investigational use IVDs are not sold for an unapproved use. Tests on the list included several tumor markers, cytomegalovirus tests, alpha-fetoprotein assays and tests for prostate specific antigen ("The Gray Sheet" Aug. 3, 1992, p. 3). The list was developed because FDA was "fearful that if we summarily lift [the tests) from the market, we would create more damage than good," Johnson said. Because the agency "has not been able to get consensus" about what tests should be on the accommodation list, the plan is being scrapped, Johnson explained. "What I thought would be a simple approach has turned out to be very complicated." The agency "recently shifted gears" and is "looking at an approach that will get us where we want to go but in a different way," the FDA topsider added. Under the new plan, most or all manufacturers of illegally commercialized research or investigational IVDs would be provided with a designated amount of time to submit 510(k)s, premarket approval applications or investigational device exemptions to FDA. "After that time," which has not yet been identified, "there are no more "get out of jail free" cards," Johnson said. During the interim period, companies would be unlikely to face enforcement action for illegal commercialization and would probably not have to follow the certification program outlined in the earlier drafts, FDAers note. However, FDA may identify a subset of noncritical IVDs for which firms would not be given the designated amount of time to make submissions to FDA; marketers of these tests would be immediately subject to enforcement action if the products are being sold improperly. Another controversial element of the draft CPGs has been the section on FDA regulation of "home-brew" IVDs created in-house by labs. In the drafts, FDA has asserted that it has the right to regulate this type of test, a position that has been questioned by the lab industry ("The Gray Sheet" Nov. 2, 1992, p. 3). Betty Collins, chief of the compliance office's IVD enforcement team, told an Oct. 5 RAPS session that the agency now plans to separate the home-brew section from the IVD CPG and issue a separate guidance on the subject. The separate home brew document currently is receiving little attention as the agency works to finish the final CPG on research/investigational use. FDA plans to focus on this document after it releases the other IVD CPG. FDA says it does not intend to routinely exercise its authority over home-brew tests because of resource constraints. Instead, FDA is looking to the Health Care Financing Administration for assistance in this area. The agencies are negotiating a memorandum of understanding under which HCFA is expected to review labs" compliance with FDA regs during inspections conducted under the Clinical Laboratory Improvement Amendments of 1988 ("The Gray Sheet" Aug. 16, In Brief). FDA says, however, that its plan to enter into the MOU does not represent an abdication of its authority over labs. The agency still plans to take action against labs if home-brew tests are being promoted for conditions with serious public health consequences and/or if the result could lead to an irreversible medical decision or intervention. The strategy was outlined in the second draft of the CPG ("The Gray Sheet" Oct. 26, 1992, p. 3).
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