USA – US FDA provides extra response time for device submissions on hold and expands virtual options

In June 2020, the US Food and Drug Administration (FDA) published a guidance document outlining the impact of the COVID-19 pandemic on meetings and user fee applications for medical devices. The agency updated the guidance in December to extend compliance deadlines for medical device companies with applications and submissions on hold.

Guidance update extends response deadlines and addresses virtual advisory committee meetings

Under normal circumstances, the FDA provides 360 days for sponsors to respond to a major deficiency letter for Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications, while 180 days are afforded to respond to an additional information letter for 510(k) and De Novo submissions…