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Updated draft guidance provides recommendations for design, labeling, and premarket documentation.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 New FDA Guidance Encourages Development of Safer Medical Devices

FDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations. This is certainly a STeP in the right direction!

Regulatory ComplianceNaveen AgarwalSeptember 20, 2019FDA, FDA regulation, FDA guidance, Medical device safety, FDA safety, safer technologies program, medical device safety action planComment

Cybersecurity is the Next Frontier of Risk Management

As medical devices increasingly become more interconnected with other devices, hospital networks and even smartphones, cybersecurity risks are quite real. Managing these risks is a product life cycle issue because they are continually evolving and may arise due to circumstances not completely foreseen during their development.