Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized Abbreviated 510(k) submission program, through which device sponsors may rely on guidance documents, special controls, and FDA-recognized consensus standards to demonstrate substantial equivalence.

The proposed “Expanded Abbreviated 510(k) program” would provide an optional, streamlined premarket pathway for certain, well-understood medical device types through which device sponsors could demonstrate substantial equivalence using objective performance criteria, rather than head-to-head testing against a predicate device. The program is intended to provide a less burdensome approach to 510(k) clearance for certain device types and may result in faster premarket review times. However, specific device types to be included have not yet been announced, and the impact of the proposed program will ultimately depend on the types and number of devices that are deemed eligible.

Read More: Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) pathway for certain devices


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