Resources & Reports

Fact Sheet

The FDA and Mobile Medical Applications

On September 25, 2013, the Food and Drug Administration (FDA) issued Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (The Guidance). The Guidance is meant to provide clarity and predictability for mobile medical application (app) manufacturers and other interested parties.

Fact Sheet

The FDA & Mobile Medical Applications

On February 9, 2015, the Food and Drug Administration (FDA) updated Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (The Guidance). The Guidance is meant to provide clarity and predictability for mobile medical application (app) manufacturers, and other interested parties. This CCHP fact sheet helps to clarify these recommendations- including 2 easy to understand charts; one which outlines the Mecial device classifications and requirements and one which summarizes the FDA regulatory enforcemtent of Medical Apps.  

Fact Sheet

FDA & Medical Device Data Systems (MDDS)

On February 9, 2015, the Food and Drug Administration (FDA) issued Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff (The Guidance). This CCHP fact sheet summarizes the purpose and intention of The Guidance.

Fact Sheet

Psychology Interjurisdictional Compact (PSYPACT)

In February 2015 the Association of State and Provincial Psychology Boards released model language to facilitate the practice of telepsychology and temporary in-person psychology across jurisdictions, referred to as the Psychology Interjurisdictional Compact. The Compact is only model language, and would have to be passed as a statute in at least seven states to come into existence.