Today, the Food and Drug Administration (FDA) issued final guidance for mobile health devices and apps intended for general wellness. The guidance provides much needed clarity for app makers in the connected health space. In response, Morgan Reed, executive director of ACT | The App Association and director of Connected Health Initiative, released the following statement:
App makers welcome this guidance from the FDA. One of the biggest challenges for companies in the wellness space is understanding how and when their technology might run into regulatory scrutiny. This guidance provides the type of clarity we have sought for a long time.The guidance makes clear that wellness companies can market how apps reduce the affects of serious conditions – for example, how nutrition apps can help diabetics stay on top of diet plans or meditation apps can help people manage anxiety. That is huge from a business development perspective, and will help a wider audience access connected innovations.While we see this as a major step forward from the FDA, we hope to see other agencies follow this as a model for regulatory guidance.
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