Device Modifications

The FDA does not currently accept supplements to amend the submission of a previ­ously cleared 510(k) device. This means that new 510(k) notifications57 must contain all the needed information. Referencing the earlier submission will not work. The 510(k) must also include supporting data to show that the manufacturer has considered the consequences that the change or new use might have on the safety and effectiveness of the device.58

The description of the modified device should include differences from the predicate device that could significantly affect safety and effectiveness. All data from in vitro, ani­mal, and human clinical testing, if any, should be included, as well as engineering, bench, and design verification data, and any other information that supports the new indication or the claim that the modified device is as safe and effective as the predicate device.

There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional,59 Special,60 and Abbreviated.61 The Special and Abbreviated 510(k) methods were developed under “the New 510(k) Paradigm”62 to help streamline the 510(k) review process. The Special 510(k) and Abbreviated 510(k) methods can only be used if certain criteria are met. The Traditional 510(k) method can be used under any circumstances.

There is no Premarket Notification 510(k) “form” to complete. A 510(k) is a document containing information required under 21 CFR §807 Subpart E. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

Updated: September 30, 2015 — 3:38 pm