Medtech Nervous About 'Sharing' Organizations Touted In US FDA Cyber Guidance

Medtech industry lobbyists say US Food and Drug Administration's recommendation for companies to join information sharing and analysis organizations (ISAOs) when dealing with cybersecurity issues is ambiguous and could have serious legal ramifications. Besides asking for clarification about what constitutes an ISAO, industry groups are calling for the agency to give companies more leeway to deal with potential cybersecurity vulnerabilities.

The comments come in response to FDA's post-market cybersecurity draft guidance issued earlier this year1,2. The guidance is intended to...