FDA to Host Medical Device Sterilization Town Hall

On February 7, 2024, the FDA will host the third in a series of medical device sterilization town halls.

The goals of the Feb. 7 town hall include:

• Understand FDA expectations for initial premarket submissions based on the 510(k) Sterility Guidance, including recent guidance changes, sterilization modality categories, and what to include in a submission.
• Understand additional device and submission considerations for sterility that impact FDA review.

FDA has the details.