S. 1622 · 114th Congress
FDA Device Accountability Act of 2016
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BurrSponsor4 cosponsors · 1 D, 3 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
What it does: CRS summary · Reported to Senate with amendment(s) · Apr 18, 2016
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FDA Device Accountability Act of 2016
Also known as: FDA Device Accountability Act of 2015
Latest action (Apr 18, 2016): Placed on Senate Legislative Calendar under General Orders. Calendar No. 426.
Policy area: Health · Origin: Senate · Introduced: Jun 18, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.