Get our free email newsletter

FDA Publishes Final Guidance on Software as a Medical Device

The U.S. Food and Drug Administration (FDA) has issued a final version of its Guidance on the clinical evaluation of software as a medical device (SaMD).

Published in early December, the Guidance adopts the regulatory principles agreed upon earlier this year by participants in the International Medical Device Regulators Forum (IMDRF), a consortium of national regulators working to streamline the global acceptance process for medical devices. The FDA says that adopting the IMDRF principles for the clinical evaluation of SaMD provides the agency with an initial framework for the further development of FDA-specific regulations in this area.

Like all guidance documents issued by the FDA and other U.S. federal agencies, the current Guidance is intended solely to provide insight into the agency’s current thinking on a topic and does not establish legally-enforceable responsibilities.

- Partner Content -

Why Capacitance? Benefits & Applications of Digital Capacitive Solutions

In this paper, readers will discover digital capacitive displacement measurement solutions not possible with conventional analog systems. The following applications address a wide range of industry sectors.

Read the text of the FDA’s Guidance on the clinical evaluation of SaMD, which includes the full text of the IMDRF SaMD document.

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.