FDA 510(k) Requirements for Devices Labeled Sterile

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Do you want to sell a sterile medical device in the United States? If so, there are specific requirements to follow when preparing your 510(k) submission. You should carefully consider which sterilization method to use because it will affect the FDA's expectations. If you fail to include to required information in your 510(k), it could delay your FDA clearance.

Luckily, the FDA published guidance to address these requirements. In this white paper, we discuss FDA 510(k) requirements for devices labeled sterile, including:

  • Which FDA guidance documents address 510(k) sterility requirements?
  • Which 510(k) submissions fall under the guidance?
  • What is the difference between "established" and "novel" sterilization methods?
  • What are the labeling and 510(k) inclusion requirements for non-Pyrogenic devices?

We answer all these questions and more in this 7-page white paper.