FDA Device Accountability Act of 2016

Summary

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."

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 18 April 2016

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• Reported to Senate (PDF)

  Reported to Senate · EN · 18 April 2016

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• Reported to Senate with amendment(s)

  summary · EN · 18 April 2016

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• Introduced in Senate (text)

  Introduced in Senate · EN · 18 June 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 18 June 2015

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• Introduced in Senate

  summary · EN · 18 June 2015

  Open at official source

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