FDA’s Pre-Certification Public Workshop: Top Line Take Aways from a Digital Health Clinician Researcher
In mid-2017, the U.S. Food and Drug Administration (FDA) published the Digital Health Innovation Action Plan. At the same time FDA’s current Commissioner, Scott Gottleib, MD, launched the Software Precertification Pilot Program, simply called Pre-Certification or Pre-Cert program. Uniqueness’s of Digital Health Technologies This program, developed under FDA’s Center for Center for Devices and Radiological Health […]
