FDA to offer webinar on new final guidance on sterility

The FDA said yesterday it will host a webinar covering newly released guidance concerning sterilization.

The federal watchdog yesterday issued a final guidance on sterilization, outlining adequate sterilization methods for sterile-labeled 510(k) devices and the appropriate documentation necessary for the premarket review of novel sterilization processes.

The Agency said its final guidance also included details about pyrogenicity testing information that sponsors should include in 510(k) submissions, according to a press release.

The webinar will be held February 11 at 2:00 p.m. EST, and will incorporate a brief presentation followed by a Q&A session.

Last week, the FDA posted draft guidance covering steps it believes medical device manufacturers should take to address cybersecurity risks. The guidance details the agency’s suggestions for monitoring, identifying and addressing cyber vulnerabilities for devices entering the market.

The FDA recommended proactively planning for and assessing cybersecurity vulnerabilities, participation in Information Sharing Analysis Organizations, and implementation of structured, systematic cybersecurity risk management programs to respond to vulnerabilities in a timely manner.

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