Health IT Now Comments on FDA Software Guidance

Health IT Now issued the following statement in response on the Food and Drug Administration (FDA) draft guidance entitled Software as a Medical Device (SAMD): Clinical Evaluation:

“Health IT Now appreciates the international community’s continued work on health IT regulation. While we are still reviewing the full draft guidance, we believe FDA reviewers, health IT developers, and the public can benefit from ongoing efforts in this area. This announcement also serves as a reminder that more needs to be done here in the U.S. to create regulatory certainty for developers and the public. We urge Congress to pass legislation currently in the 21st Century Cures Act & the Senate Innovation Initiative that would clarify which types of products would be subject to FDA regulation before the end of the year.”