Posts tagged FDA medical devices

How FDA is Shaping a Regulatory Policy for Device Cybersecurity

Updated draft guidance provides recommendations for design, labeling, and premarket documentation. Industry response points to a long road ahead before it can be finalized.

Regulatory ComplianceNaveen AgarwalNovember 20, 2019FDA medical devices, FDA guidance, regulatory policy, regulatory news, device cybersecurity, medical device security, medical device cybersecurity, FDA safety, FDA regulation, WannaCry ransomware attack, WannaCry ransomware, URGENT/11, healthcare, cyberthreats in healthcare, healthcare securityComment

A Pathway to Faster FDA Approvals

FDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.