FDA Software Precertification (Pre-cert): A Working Guide for Medical Device Companies

In recent years, we have seen digital health technologies moving toward rapid adoption in the United States. Yet, makers of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems are often anxious about the lengthy and detailed process of the existing FDA’s premarket review for medical devices. The FDA Software Precertification (Pre-Cert) Program aims to streamline the current premarket review process and reduce unnecessary regulatory burden for both medical device software manufacturers and the FDA. In this white paper, we explore the Pre-Cert program in the context of the FDA’s overall strategy and provide medical device companies with a working guide on how to leverage these regulations.