What The FDA's New Pre-Certification Program Means For Digital Health And Medical Device Industries

Published: Aug 28, 2017

The digital health ecosystem is all excited about the FDA’s recently announced pilot program to offer pre-certification (pre-cert) options for digital health technologies, bringing them under the purview of what is being referred to as software as a medical device or SaMD. This is seen as an opportunity to accelerate innovation without the stifling controls and processes normally associated with the approval of medical devices.

The FDA’s announcement inviting applications for the pilot program states that the pre-certification will be provided to software development shops that demonstrate a culture of quality in software development and testing.

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