Expanded Third-Party 510(k) Program Includes 47 Additional Class II Devices
This article was originally published in The Gray Sheet
Executive Summary
Devices among the 47 additional Class II devices slated for inclusion in FDA's new "Accredited Persons" third-party 510(k) program with the highest levels of FY 1997 510(k) submissions are endoscopes/endoscope accessories with 121 510(k)s and electrosurgical cutting/coagulation devices with 86 submissions.