Sep 21, 2012
It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues.
The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.
Key FTC guidelines include:
Although a definitive FDA regulatory approach to mobile medical apps remains in the works, guidance from the FTC on how app developers should meet additional US legal requirements should provide a clearer—if not yet altogether clear—roadmap to compliance and commercialization in the US.
Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?
Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.
At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr.