US FDA : The “Traditional”510(k) 

- Part III

Now, let us open the notebook and flip through the pages.  This 510(k) has numbered tabs. You could also use letters rather than numbers. All the pages are white. The pages are 8.5 inches by 11 inches in size with a 1.5" (3.8 cm) 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.

The pages can be consecutively numbered throughout the submission. Alternatively, numbering pages by section can be done. For example: Section 1 pages could be numbered 1-1, 1-2, etc. Section 2 pages will then be numbered 2-1, 2-2, etc. Sequential numbering can help reduce errors and is easier to correct if a page is added or removed at the last moment before submission. Numbering is important because if someone removes a page for photocopying or, perhaps, drops the submission, without consecutive numbering, “all the Kings horses and all the King’s men” could not put it together again. You should not permanently bind the submission because the FDA needs access to individual pages.

Notice that the 510(k) submission can have tables or charts, diagrams, drawings, figures, photos or illustrations.  Be sure to give them a title and a number and refer to them properly in the text.  Note also that all the pages are in English or English translation is included.

Notice also that some pages are stamped “CONFIDENTIAL”. These pages contain commercially valuable information that you do not want to see in the hands of your competitors.  For example, pages containing specifications, engineering drawings, test protocols and laboratory reports are usually stamped as confidential.

Overview of Format

If you looked at a library of 510(k) submissions, they may vary a lot in size but they all have the same types of information. The following is an example of a format that can be used.  The actual order is not as important as the types of information that are necessary. Not all of these will be applicable to your specific device.  For example, you do not need a “Software” section if your device has no software.  Here is the list:

1. Cover Sheet or Cover Letter

2. Table of Contents

3. General Information

4.  Indications for Use Statement

5. Device Description

6. Proposed Labeling

7. PerformanceTesting

8. Clinical Data

9. Substantial Equivalence Information

10. Information on Sterilization

11. Software

12. Applicable Standards

13. 510(k) Summary or Statement

Each of these sections, in turn, contain information that is important for FDA’s review.  We shall discuss each of the sections next time.  Also, do not forget to include a copy of the Medical Device User Fee Cover Sheet with your submission.

Stay safe and healthy!

Norman F. Estrin, Ph.D., RAC

June 6, 2003

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NOTE TO READERS: Please understand that in order to make FDA requirements more understandable, I do simplify some of the language and omit some details. You must rely on the actual regulations-not any of my columns to ensure you meet FDA requirements.