Medical Devices

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. Use numbered or lettered tabulation sheets to separate the sections in the 510(k). This will make it easy for the reviewer to refer or search back and forth during the review.
  5. Number the pages of the 510(k), verify the page numbering when finished. Make sure the page numbering or pagination corresponds to the page numbers or section numbers in the Table of Contents. Numbering pages by section is acceptable. For example: Section 1 pages could be numbered 1-1, 1-2, 1-3. Section 2 pages will then be numbered 2-1, 2-2, 2-3, etc. Likewise, letters can be used: Section A, B, C, etc. Numbering by section is a little faster than sequential numbering, helps reduce errors, and is easier to correct if a page is added or removed.
  6. Use 8.5" x 11" (21.5 cm x 27.8 cm) 3-hole punched, white paper only; do not use colored paper.
  7. Leave a 1.5" (3.8cm) margin between the left edge of the paper and the left margin of the text. This leaves enough space for FDA to bind the 510(k) in the review jacket.
  8. Place the 510(k) in an inexpensive jacket or non-permanent binding. All 510(k)s are removed from the shipping binder and placed in standard jackets. The shipping binder will be discarded.
  9. 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.

Page Last Updated: 08/11/2014
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