Category Archives: Table of Contents

Format Content of a 510(k) Submission

Article summarizes format content requirements for a 510(k) submission to the US FDA for medical devices, including volume and document organization. The FDA requires that your 510(k) submission is organized into 20 sections as described in the adjacent table. You must provide both a hardcopy of the submission and an electronic copy (i.e., eCopy) that is identical to the hardcopy

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