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Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon...more

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