In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.

On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to strengthen regulation of certain in vitro diagnostics (IVDs), including laboratory developed tests (LDTs). On the same day, the Agency also released final guidance on IVD companion diagnostic devices. These actions follow the enactment of substantial legislative changes to Medicare reimbursement methodologies for certain LDTs and other tests performed in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA). The Centers for Medicare & Medicaid Services (CMS) has solicited stakeholder views and concerns about the implementation of the legislation, including the promulgation of regulations to be published in 2015.

FDA first released a notice of its intent to issue two new draft guidance documents related to the regulation of LDTs on or after September 29, 2014. FDA has historically exercised its enforcement discretion to exclude LDTs from the regulatory requirements applicable to other medical devices. If the draft guidance documents are finalized, LDTs will, for the first time, be subject to FDA’s comprehensive medical device regulations. The process is anticipated to be phased in over nearly a decade, and will utilize a risk-based framework. In an Agency statement, FDA Commissioner Margaret A. Hamburg, M.D. said, “[the] action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”