FDA Releases Mission, Vision, and Shared Values

The core of strong organizations can be found in its mission and its vision. The Center for Devices and Radiological Health (CDRH), the body of the FDA dedicated to medical devices, strives, just like an private company, to be a strong organization. In an attempt to meet this goal, FDA has released their Mission, Vision, and Shared Values statements.

FDA Missions & Vision

In the unpredictable regulatory environment manufacturers find themselves in at the moment, any glimpse into the FDA psyche is a small glimmer of hope. The section I find particularly useful is the "Shared Values" section as it essentially outlines the FDA's expectations for submissions.

Public Health Focus - Safe and effective treatment

Transparency - Strive to give manufacturers predictability in regulatory processes (a stated trade-off for the higher user fees proposed in MDUFMA III)

Science-Based Decisions - As always, objective evidence will rule the day in submissions.

Innovation - FDA recognizes their role in fostering new technologies, products, and methods, though not irrespective of the other values.

-RTK