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Coming soon to a laboratory near you? FDA’s Proposed Framework for Laboratory Developed Tests By James A. Boiani JD, ESTEIN BECKER GREEN
and patients. However, these tests are self-validated by laboratories and subject to much less-extensive oversight by the Center for Medicare and Medicaid Services (“CMS”). For nearly 40 years, FDA has chosen not to regulate. However, on July 31st FDA signaled this may change soon due to Agency concerns about the lack of FDA oversight, and the negative impact the dual system of regulation has on development of IVDs.
On July 31, 2014, the U.S. Food and Drug Administration ("FDA”) announced plans to regulate laboratory developed tests (“LDTs”). LDTs are an integral part of healthcare today, serving as diagnostic tools for many serious diseases and genetic conditions, II. FDA’s Proposed Framework so it’s incumbent on everyone who is for LDT Regulation a physician, laboratorian, diagnostics FDA would require many LDTs to developer, or future patient (which is all of us) to understand the proposed plan come into compliance with FDA IVD requirements on a risk-based schedule. so we can consider its impact. The framework would be phased in over I. The Current State of nine years from date final FDA guidance Lab Diagnostic Regulation is published (there is no timeline for Currently, diagnostic tests used by finalization, but a year-plus would not
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clinical laboratories in the United States be unexpected, given that FDA will be are developed and introduced into the soliciting and considering comments clinical environment in one of two ways: from stakeholders). Subject to exceptions (discussed below) and assuming there 1. The IVD Path. In vitro were no changes from the proposal, diagnostics (“IVDs”) are tests after its finalization – that are intended to aid in ∙ Within six months, laboratories diagnosing disease. These tests must tell FDA what LDTs they are designed, manufactured, and perform, and begin reporting sold to clinical laboratories by serious injuries and certain FDA-regulated manufacturers malfunctions associated with that are subject to extensive LDTs. FDA requirements covering FDA review and marketing ∙ Within one year, a laboratory approval/clearance of IVDs, must submit an application for manufacturing, postmarket authorization to market high safety reporting, and product risk LDTs, including any LDT promotion. that is intended to substitute for an FDA-cleared/approved 2. The LDT Path. LDTs are tests companion diagnostic (tests designed and manufactured by a that guide the use of specific single laboratory for in-house use. therapeutics), FDA-classified An LDT provides diagnostic test results relied upon by physicians
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October 2014