US FDA Medical Software Report Rests Concerns Of Increased Regulation
Executive Summary
Based on a provision in the 21st Century Cures Act, US FDA has released a report that shows that certain types of medical software not regulated by the agency is overwhelmingly beneficial to the public with few risks. The report seems to allay industry fears that FDA may use it to ask for more oversight authority of such products.
You may also be interested in...
US FDA Asks For Public Input On Software It Can't Regulate
FDA is writing a report on key safety impacts from health software products that fall outside of its regulatory purview under the 21st Century Cures Act. To help the effort, the agency is asking industry, patient groups and other stakeholders to chime in by June 28.
Massive Family Dollar Rat Infestation Leads To Multi-State Recall
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.