FDA Proposes Total Product Lifecycle Approach to AI Devices
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed regulatory framework. Read More
UK Gets Halloween Extension, But Brexit is Still Scary
British Prime Minister Theresa May won yet another delay from European leaders on the UK’s exit from the EU, leaving devicemakers no clearer about the ultimate impact of Brexit on the supply chain. Read More
Devices News
IMDRF Advances Regulatory Convergence in Moscow Meeting
Russia signed an agreement with Brazil, Argentina and Mexico to share best practices and information on quality, efficacy and safety of medical products as well as adverse event information, on the first day of the International Medical ... Read More
IMDRF Pursues Global Clinical Device Evaluations
The IMDRF’s Medical Device Clinical Evaluation Working Group, led by China, released three related consultation documents aimed at integrating regulations across regions to better evaluate clinical data and reduce redundant clinical tria... Read More
Inova Genomics Lab Warned for Selling Unapproved Genetic Tests
The FDA warned Inova Genomics Lab for marketing pharmacogenomic and whole gene sequencing tests without the agency’s approval or clearance. Read More
Specification Developer Fails to Submit MDR Reports
Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018... Read More
