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:
We answer all these questions and more in this 7-page white paper.
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system t
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