Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List

The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.

By this time next year, device makers should have a clearer picture on how the US Food and Drug Administration plans to regulate some high-profile devices and implement its new safety and performance pathway – at least, if the agency stays true to a prioritized list of proposed guidance documents for fiscal year 2021 that was released on 16 October.

The FDA issues a list of planned guidance documents at the start of each fiscal year, which is divided between...