Tips from industry peers who are going through the process.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.
Shift the odds in your favor.
A guide to a risk-based CAPA program for device manufacturers.
Industry shifts focus to proactive measures in addressing vulnerabilities and promoting cybersecurity.
FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
As the incidence of GI conditions grows, device companies in this segment should explore expansion in the region.
The recently released draft guidance on cybersecurity stresses the importance of preparation versus reaction.
Announced at CES 2016, the cognitive app will leverage predictive analytics to help patients better manage their condition.