In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.
In the final days of the Obama Administration, the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) issued over a dozen draft and final guidance documents. It appears the CDRH was anticipating that this might be its last chance to issue formal guidance to the industry before the Trump Administration imposed its much talked about regulatory slowdown. CDRH’s new guidance documents address a broad range of topics including: investigational device exemptions, cybersecurity, combination products, postmarket surveillance, and medical product communication.