Developments in 2018

In 2018, FDA continued to express its interest in overhauling the regulatory framework applicable to in vitro diagnostic tests, including the laboratory-developed tests (LDTs) for which the agency currently exercises enforcement discretion. Notably, 2018 saw the FDA release long-awaited Technical Assistance on the House Energy and Commerce Committee’s draft Diagnostic Accuracy and Innovation Act. The Technical Assistance reflects several notable changes in the agency’s position—most notably with respect to the agency’s willingness to “grandfather” many currently marketed LDTs into a new diagnostic-specific regulatory scheme (i.e., not to require that such products comply with many of FDA’s regulatory requirements, such as pre-market review). Moreover, FDA indicated its support for the review and approval of prospective protocols, under which test developers and would identify types of changes and procedures for test validation following such changes, and if the agency approved such protocols, developers could make such modifications without a supplemental pre-market filing.

Looking Ahead to 2019

In December 2018, the US House of Representatives Energy and Commerce Committee released an updated draft bill related to in vitro clinical tests (IVCT)—now titled the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018—that is largely consistent with the FDA Technical Assistance. The Energy and Commerce Committee is accepting comments on the draft VALID Act from interested stakeholders until mid-February 2019, and is expected to hold hearings on diagnostic regulatory reform early in 2019. Stakeholders should stay apprised of the status of this bill and other legislative developments, which may have a substantial impact on FDA’s oversight of diagnostics.

Read more on FDA 2018 Year in Review.