Innovative Device Approvals Slowed in 2016, Report Finds

March 28, 2017

The FDA granted fewer first-time premarket approvals for innovative devices last year than in 2015 and approvals took longer.

Just 38 first-time premarket approvals were granted to innovative devices in 2016, down from 51 the year before, the ECRI Institute said. The agency took an average of 18.1 months to grant the approvals, compared with 17.3 months in 2015. Cardiology devices were approved fastest in 2016, taking an average of 13.3 months.

Section 3051 of the 21st Century Cures Act could speed up approvals this year. It requires the FDA to establish a program to expedite the development of innovative devices that are designed to diagnose or treat serious conditions and that have no approved or cleared alternatives.

The agency approved no products in 2016 under the humanitarian device exemption (HDE), which requires a slightly lower standard to prove efficacy. Six HDE approvals were granted in 2015, and four in 2014.

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