SCM NEWS & OPINIONS

FDA releases 5 updated medical device documents

FDA releases updated draft guidelines on premarket notifications relating to ultrasound devices.  This draft guidance is intended to replace guidance from 2008.  Also released are guidance documents relating to appeals processes for devices regulated by the Center for Devices and Radiological Health, deficiency letters and display devices intended for use in diagnostic radiology.  For more information, please read this piece from the Regulatory Affairs Professional Society.

For questions about this and all other healthcare related legal issues, contact Bradley R. Blackham.

Bradley R. Blackham