FDA Device Accountability Act of 2016
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local.
(Sec. 3) The Food and Drug Administration (FDA) must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”
(Sec. 4) The FDA must ensure that employees who review premarket submissions of medical devices receive training on least burdensome means requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a sponsor to demonstrate the effectiveness of a medical device or demonstrate a device’s substantial equivalence to an approved medical device.) The FDA must periodically assess the implementation of those requirements. The ombudsman for any applicable unit of the FDA must audit and report on the training.
The FDA must consider the least burdensome appropriate means necessary to demonstrate medical device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, including the role of postmarket information in such a demonstration.
The FDA’s documented rationale for a significant decision regarding a medical device must include a statement regarding how the least burdensome requirements were considered and applied.