FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications


On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will supersede the existing 1997 guidance on the same topic. Issuance of the draft guidance fulfills one of the proposals set forth in FDA’s August 2010 blueprint for reform of the 510(k) clearance process. As drafted, the guidance could result in a significant increase in the number of 510(k) notifications filed for device modifications.

In its August 2010 report evaluating the 510(k) process, FDA expressed concern that manufacturers are only filing a 510(k) for modifications that “significantly affect the safety or effectiveness of the device,” not for modifications that “could significantly affect the safety or effectiveness of the device.” In other words, FDA’s concern is that some manufacturers do not file a 510(k) if the change has the potential to affect the device’s safety or effectiveness. Accordingly, the draft guidance emphasizes the requirement that manufacturers assess the potential of modifications to impact safety and effectiveness, which likely will result in a higher number of 510(k) submissions for modifications.

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