USA – Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules
Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact...
USA – FDA drafts guidance to aid orthopedic implant guide makers
The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
USA – Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed...
The US Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have formed a partnership aimed at curbing medical device shortages. A 22...
