Posts tagged FDA premarket guidance

FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission.

Regulatory ComplianceNaveen AgarwalApril 2, 2020FDA Guidance, interoperable devices, FDA on interoperable devices, interoperability, medical device innovation, regulatory policy, medical device regulatory policy, premarket guidance, FDA premarket guidance, interoperable medical devicesComment

Regulatory Update on Medical Device Cybersecurity

Cybersecurity of medical devices is a rapidly evolving area of concern. Here is an update on recent FDA activities.