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FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of the … Continue Reading

FDA Issues Final Unique Device Identifier Rule

On Friday, FDA released a final rule implementing a “unique device identifier” (UDI) system.  The final rule retains the basic framework and most of the key requirements of the proposed rule.  (For a summary of the proposed rule, see our July 16, 2012 client alert.)  Nevertheless, the final rule contains several important differences from the … Continue Reading

Mobile Medical Apps: What Will Future FDA Regulation Look Like?

Over the next year, stakeholders may see several important developments related to FDA’s regulation of mobile health (also known as “mHealth”) devices, especially in the rapidly developing area of mobile medical apps. The universe of mobile medical applications (or “apps”) continues to grow rapidly. According to a recent Washington Post article, MobiHealthNews, an app-developer trade … Continue Reading