Application Developers Alliance Urges FDA to Convene Application Developers, Publishers, and Stakeholders on Mobile Medical App Guidance

Washington, D.C. (August 1, 2012) Today, the Application Developers Alliance urged the Food and Drug Administration (FDA) to consult app industry stakeholders as the agency develops a regulatory framework for mobile medical applications. In a letter sent to Commissioner Margaret Hamburg and to Director Jeffrey Shuren, of the Center for Devices and Radiological Health, the Alliance asked FDA to “convene app developers, mobile app publishers, external stakeholders, and experts” without delay, as Congress encouraged in the Food and Drug Administration Safety and Innovation Act, signed by President Obama on July 9, 2012.

“In the Food and Drug Safety and Innovation Act, Congress suggested that app developers and other industry stakeholders be engaged as the FDA crafts its mobile medical application guidance. App developers are ready to work with the FDA and other regulatory agencies in developing mobile medical app guidance and welcome the regulatory clarity this guidance will bring,” said Jon Potter, Alliance President, when releasing the letter. “Our members’ input will help ensure that the FDA’s final guidance recognizes the needs of the fast-moving app ecosystem while also ensuring that medical devices are properly classified, safe, and effective.”

About Application Developers Alliance

The Application Developers Alliance is an association dedicated to meeting the unique needs of application developers. Alliance members include 8,000 individual application developers and dozens of companies, investors, and stakeholders in the apps ecosystem.