Develop Clinical Evidence of Substantial Equivalence to Predicate Devices

Investigator: Suellen Miller, PhD, CNM, MHA
Sponsor: Program for Appropriate Technology in Health (PATH)

Location(s): United States


Demonstrating Substantial Equivalence is one of the steps required when bringing a medical advice to fruition, when making significant modifications to a marketed device, and when a person required to register with FDA introduces a device for the first time.