medical device cybersecurity

A new Senate bill could require cybersecurity reviews and even mandatory recalls of Chinese-made medical devices already deployed across U.S. healthcare systems. Find out what the proposed Countering CCP Act could mean for manufacturers, providers, and patient safety in the months ahead.

The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.