Categorized | Colorado News, National News, News

Regs. for Mobile Health Apps in the Works at FDA

The U.S. Food and Drug Administration has stated its intent to create a regulatory framework for mobile medical apps that will both foster innovation and provide consumer protections.   The FDA has chosen to not interfere with low-risk health care apps but sees the necessity for involvement in more sophisticated apps that are available for public use.

According to the FDA, the main goal of the program is to  “provide more streamlined and efficient regulatory oversight of software-based medical devices from manufacturers who have demonstrated a robust culture of quality and organizational excellence (CQOE) and are committed to monitoring real-world performance.

Read the Pre-Certification Model from the FDA.

Read more at JAMA.

Read more on the FDA website.

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