China to Allow Use of Overseas Trial Data in Device Applications
In a significant policy shift, China plans to accept data from foreign clinical trials in its medical device approval process if the device is already approved overseas. Read More
FDA Commits to Patient Engagement at Inaugural Advisory Committee Meeting
Examining how well medical device companies engage with patients in clinical trails is becoming part of the new normal at the FDA, say agency officials. Read More
Devices News
Medical Device Firms in Puerto Rico Still in Recovery Mode
Devicemakers in Puerto Rico continue to grapple with the widespread destruction left by Hurricane Maria. Read More
MHRA Guidance Lists Steps for Notified Bodies to Assess Combo Products
Notified bodies will need to clear a few more hurdles when recommending a CE Mark for a drug-device combination in the UK. Read More
House Bill Targets Healthcare Cybersecurity
U.S. Representatives Dave Trott (R-Mich.) and Susan Brooks (R-Ind.) introduced legislation aimed at safeguarding healthcare technology as the industry has become a target for ransomware and cyber attacks. Read More
FDA Proposes Framework for Quality Manufacturing Pilot Program
The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions. Read More