FDA Simplifies Tips for Electrosurgical Device, Vessel Sealer Submissions
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers meant for general surgery can skip studies on FDA-approved components, the FDA says.
In a pair of final guidance documents, the FDA is now advising sponsors to rely on an original 510(k) as a reference, allowing sponsors to avoid additional trials for the component or accessory. This, however, does not exempt sponsors from having to demonstrate compatibility between components or accessories and the proposed device.
The final guidance documents contain minimal revisions from their draft versions, both of which were released in March 2014. — José Vasquez