Monthly Archives: January 2017

Pre-submission Meeting Request Feedback Options

Article analyzes feedback methods offered by the FDA for a pre-submission meeting request and gives you insight to which option is best for your situation. In 2014 the FDA published a guidance document about pre-submission meeting requests (i.e., pre-sub meetings). The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA. The

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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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