Companies Nervous About 'Sharing' Organizations Touted In FDA Cyber Guidance

Industry lobbyists say FDA's recommendation for companies to join Information Sharing and Analysis Organizations 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The comments come in response to FDA's postmarket cybersecurity draft guidance issued earlier this year. (See [A#01160125004].) It is intended to complement a premarket cybersecurity guidance finalized in 2014....