Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration oversight.

*/ /*--> */ Nach der Veröffentlichung der endgültigen Richtlinie für mobile Medizin-Apps durch die US Food and Drug Administration sollten Entwickler und Hersteller eine bessere Vorstellung davon haben, welche Produkte in den USA reguliert werden und welche nicht. Die Richtlinie teilt mobile Apps in drei Kategorien ein:

Now that the US Food and Drug Administration’s final guidance on mobile medical apps is finally published, developers and manufacturers should have a much better idea of which products will fall under regulatory oversight in the US and which will not. The guidance divides mobile apps into three broad categories:

Die lange erwartete endgültige Leitlinie (Text auf Englisch) der US Food and Drug Administration weist auf eine beschränkte Regulierung von mobilen Medizin-Apps hin. Die Behörde plant nicht, den Federal Drug and Cosmetic Act für die meisten dieser Produkte durchzusetzen.

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). Targeting specific subsets of mobile medical device applications , the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.