510(k) medical software

By Dave Muoio March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry. “The exponential advancement of digital health technologies presents a...
By Jonah Comstock October 24, 2017
The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program. "Medical device technology evolves quickly. The process for improving the performance and clinical...
By MHN Staff November 11, 2013
By Bradley Merrill Thompson More than three years have passed since I wrote the first edition of this e-book for MobiHealthNews, and much has changed. Among other things, FDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content...

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