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U.S. Food and Drug Administration
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  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Notification 510(k)
  7. 510(k) Format Tips
  1. Premarket Notification 510(k)

510(k) Format Tips

We recommend the following format tips for a 510(k) submission:

  1. Because there can be several parties involved in the submission of a 510(k) e.g., manufacturer, consultant, correspondent, etc., FDA suggests that you plainly state who the 510(k) owner is for each submission. The 510(k) owner is the individual or firm that has legal authority to the 510(k). Only one firm may own a 510(k). Identify the person(s) FDA should contact during the review process. Clearly provide an e-mail address for the 510(k) point of contact. You may notify the lead reviewer of your 510(k) via email of any changes to the contact information before a final decision is made. You should reference the 510(k) number in any correspondence regarding your 510(k). We cannot change the 510(k) after a final determination is made on the 510(k).
  2. Please include a Table of Contents which clearly identifies each section title and corresponding page number in the 510(k). The table of contents should include a list of attachments and appendices, as appropriate. Begin each section on a new page and separate each section with tabs.
  3. Provide a title and/or number for any diagrams, drawings, figures, illustrations, photos, charts, or tables that are used. Make sure citations in the text refer to them correctly.
  4. Sign and date the cover letter.

Maintain all FDA correspondence with your copy of the 510(k) submission, including FDA's request for additional information, if any, any additional information sent to FDA in response to FDA's request for data, and a copy of your letter of substantial equivalence (510(k) clearance letter). You may need this information to show an FDA investigator during an inspection of your establishment.

 
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