CDRH Posts List of Proposed Guidances for Fiscal 2019

CDRH has published a list of guidance documents it plans to publish in FY 2019, as well as a list of finalized guidances available for public comment.

The center intends to publish final guidance in 2019 on the breakthrough devices program, on least burdensome provisions and on showing substantial equivalence through performance criteria.

Draft guidance topics include labeling for surgical staplers and staples, content to include in premarket submissions for cybersecurity of devices and lifecycle regulatory requirements for medical device servicing.