FDA & Regulatory Approach

MOBILE MEDICAL APPS

Swathi kiran Sarihaddu

What is a Mobile Medical App? It is a medical device which is a mobile app, meets the medical device defi-

nition and is an accessory to a regulated medical device (or) transform a mobile platform into a regulated medical device.

App is likely a device if it

Other factors to be considered are app’s intended uses, interactions, and determination whether if an app qualifies as a medical device.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm

Amplifies Analyses Attaches Interprets Calculates Controls Converts Cures 

Detects Diagnoses Manipulates Measures Monitors Programs Trends treats

FDA guidance on Mobile Medical DevicesUpdated Guidance document was released on February 9, 2015. It indicates which mobile medical apps falls under medical device regulatory requirements and which do not.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

Examples of FDA approved and regulated MMA’S

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368784.htm

U.S FDA REGULATORY PROCESS Mobile Medical App’s fall under the same regulatory requirements as other medical devices. Classification is based on the level of risk it poses to users and it is also based on Whether substantial equivalence (SE) exists.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368743.htm