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.

FDA Device Accountability Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to ensure that employees who review premarket submissions of medical devices receive training on least burdensome requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a device sponsor to demonstrate the effectiveness of a device or its substantial equivalence to an approved device.) The FDA must periodically assess the implementation of those requirements.

The ombudsman for any applicable unit of the FDA must conduct an audit of the training on least burdensome requirements.

The FDA must consider: (1) the least burdensome appropriate means necessary to demonstrate device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, and (2) whether the least burdensome means would be reliance on postmarket information. The documentation of rationale for an applicable significant decision must include an explanation of how the least burdensome requirements were considered and applied.

The Institutional Review Board responsible for reviewing the plan for the clinical testing of a medical device no longer needs to be local to the facilities where the testing will be conducted.

The Department of Health and Human Services must revise its guidance entitled "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices."