How to Prepare and Submit a Traditional 510(k)?

Typically, Medical Device Manufacturer in the US has three types of Premarket Notification 510(k) to be submitted to FDA (1): Traditional, Special and Abbreviated. Special and abbreviated methods can only be deployed if certain criteria are met (1). The traditional 510(k) method can be used under any circumstances. It is a requirement under 21 CFR 807 Subpart E.

 When a sponsor need to file for 510(k), the regulatory department should always visit the FDA to ensure they have the latest guidelines and requirements. It also depends on the medical device technology and intended use of the device in question. This blog is for general knowledge of how to prepare and submit a 510(k), BUT in actual process, it will be much more detail and a lot of work required.

 The following is the ‘general’ and simplistic content and format of a traditional 510(k) to be submitted with a premarket notification.  Note: Not all content and format of a 510(k) are identical. Here is the general content and format. This is only for traditional 510(k). Sponsor should provide descriptive information about indication of use and technology, results of performance testing to demonstrate substantial equivalence. Sample is shown below (1).

1)    Medical Device User Fee Cover Sheet (Form FDA 3601)

2)    CDRH Premarket Review Submission Cover Sheet

3)    510(k)Cover Letter

4)    Indications for Use Statement

5)    Table of Contents

6)    510(k)summary or 510(k) statement

7)    Truthful and Accuracy Statement

8)    Class II Summary and Certification

9)    Financial Certification or Disclosure Statement

10) Declarations of Conformity and Summary Reports

11) Executive Summary

12) Device Description

13) Substantial Equivalence Discussion. In this section, a detail comparison between the device to be marketed and the predicate device or devices. You can compare with only one or more than one predicate device.

14) Proposed Labeling

15) Sterilization and Shelf Life

16) Biocompatibility. It involves some biocompatibility testing and the testing report as well.

17) Software. Not all medical device has software. Software also has its own ‘medical device’ guidance to follow. We will discuss software in some other blogs.

18) Electromagnetic Compatibility and Electrical Safety. Not too many medical device manufacturers can afford to perform this type of testing. Usually, several samples will be submitted to third party testing outfit to be done.

19) Performance Testing-Bench. Submit the bench testing results.

20) Performance Testing-Animal. Submit the animal testing results.

21) Performance Testing-clinical. Submit the clinical testing results.

22) Others.

                    Where to Submit a 510(k)
 

A 510(k) should be organized in a temporary and inexpensive binder. It is not advised to bind all the documents for 510(k) because the reviewers might take the submission out for review (1). Paper size should be the usual 8.5 inches by 11 inches.

Two copies of the 510(k)s must be submitted and one of the copy must be electronic form. The address should be send to:

 Food and Drug Administration *
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

 

1.—How to Prepare A Traditional 510(k), FDA websites, Page Last Updated:
   12/17/2013.

 2. Source; ---Guidance for Industry and FDA staff: Format for Traditional and
    Abbreviated 510(k), August 12, 2005, FDA, CDRH.