Guide to Building a Successful 510(k) Submission

This paper will help you avoid the most common pitfalls that cause delays in the 510(k) submission process. Writing and assembling a complete and well structured 510(k) submission, as well as following the suggestions and guidance that FDA provides to the Medical Device Community, drastically improves the likelihood of FDA clearance on the first pass. This will save you time and money, and can make your product more competitive in the market.

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