Case Study 42: Registration of Class II Medical Device in USA via 510(K)

Company Situation

The Client is a EU based manufacturer of infusion pumps that obtained the CE mark in Europe for its devices and was seeking a partner in USA that can support him register of the infusion pumps with US FDA via 510(k) pathway. The infusion pumps are Class II medical devices in USA.

GRP Solution

GRP has track of obtaining 100% clearance from FDA for medical devices under 510(k) application. GRP reviewed Client’s infusion pump technical file for completeness of documentation, developed a strategy for application submission, prepared and submitted the 510(k) application to FDA.