FDA Public Workshop – Fostering Digital Health Innovation

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Date(s) - 30 Jan 2018 until 31 Jan 2018
8:30 AM - 5:00 PM


Public Workshop – Fostering Digital Health Innovation: Developing the Software Precertification Program

– January 30-31, 2018

The Food and Drug Administration (FDA), is announcing the following public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take in to account real world evidence while incorporating principles established through international harmonization.

Date, Time and Location

This meeting will be held January 30-31, 2018, beginning at 8:30 am – 5:00 pm EST at the following location:

National Institutes of Health (NIH) Campus 
9000 Rockville Pike 
Ruth L. Kirschstein Auditorium
Natcher Conference Center, Bldg. 45
Bethesda, MD, 20892

The entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed.


This workshop will be webcast. Registration is required.