US FDA requires 510(k) clearance for surgical staplers for internal use

Recently, the US FDA, on its own initiative, has reclassified surgical staplers for internal use from Class I (general controls) to Class II (special controls) and required these devices to undergo 510(k) premarket review.   

Reclassification

FDA removed surgical staplers from the classification regulation for manual surgical instruments for general use (21 C.F.R. 878.4800), which are Class I devices that are exempt from 510(k) requirements and created a new classification regulation specifically for surgical staplers (21 C.F.R. 878.4740). In the new classification, FDA distinguishes between surgical staplers for internal use, which are Class II devices that require 510(k) premarket clearance, and surgical staplers for external use, which remain Class I 510(k)-exempt devices. The regulation lists the special controls that apply to surgical staplers for internal use, including performance data, human factors testing, and labeling requirements. More information on the final order (FDA-2019-N-1250) can be found here.

Labeling recommendations

In addition, the FDA has issued a guidance document that provides labeling recommendations for surgical staplers for internal use. These recommendations are intended to help manufacturers develop labeling that complies with the required special controls. The information on the labeling is intended to supplement, not replace, good clinical judgement.

How can TSG help?

Laurie Clarke, VP & Principal of TSG’s Medical Device Regulatory practice, would be happy to assist manufacturers of surgical staplers for internal use should they have any questions regarding FDA’s regulatory changes. Get in touch: [email protected]