The U.S. Food and Drug Administration (FDA) is providing an update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot Program. In 2019, the FDA launched the Pre-Cert Pilot Program to better understand how new approaches can be used to provide safe and effective medical device technologies to benefit patients. With this status update, the FDA is highlighting what we learned from testing activities under the Pre-Cert Pilot Program and how we will use this information for the next iteration of building and testing.
Read the Update
The FDA is also releasing a video that explains the FDA’s vision for Pre-Cert, and how the program is being developed.
Watch the Video
Questions?
If you have questions, email digitalhealth@fda.hhs.gov.
.png)
No hay comentarios:
Publicar un comentario