December, 2017, Silver Spring. FDA Commissioner Gottlieb announced last week the issuance of three new guidances intended to clarify FDA policy regarding digital health and digital health products of specific intended uses. The announcement includes links to the three guidances, and may be reviewed and or acquired here.
The CRO Group specializes in assisting SaMD developers and medical device manufacturers navigate through the FDA clearance process, and has the scoop on the new Guidances and their applicability to your business and projects. If this is all new to you, or you prefer to hire a consultancy to review your projects and provide the info you need so there’s no surprises, or if you’d like to take a chance – we award one lucky person each month who ‘likes’ us and the December draw is coming up: