July 26, 2011

FDA Revisions to the 510(k) process

The FDA has just issued a new draft document detailing if medical device manufacturers who have a product previously cleared by the 510(k) process, and have made changes to that product, have to refile another 510(k) for that product. The two main questions that a device manufacturer must ask about their revised device are as follows:

1. Have the changes significantly affected the safety or efficacy of the device?
2. Has there been a major change or modification in the intended use of the device?

If the answer is yes to either of these questions, then a resubmittal of the 510(k) application may be necessary. The predicate for the resubmittal should be the cleared and marketed device on which the modifications have been made, as opposed to a competitor device or another device marketed by the manufacturer. Changes are not limited to material or design, but also to manufacturing process changes that meet one of the above two questions. Packaging, labeling, and sterilization modality are included in these criterion.

More information can be found on the FDA web site