FDA to Host Medical Device Sterilization Town Hall

Feb. 5, 2024
Sterilization is a critical step in the manufacturing process for certain medical devices

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.

Original photo courtesy Bayhealth SPD, HPN's 2021 SPD of the Year, with affects added by generative AI.
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