Wearable Medical Device & Mobile Apps in US

E

esh14

#1
Hi, I'd like to find out the classification system for a wearable device & mobile apps (or mobile medical apps) based on the FDA regulation. Do we have to register them separately?

Also, can anyone tell me if the application of Medical Device Data Systems (MDDS) is applicable for my devices?

Thank you.
 
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Ronen E

Problem Solver
Moderator
#2
Hi,

Hi, I'd like to find out the classification system for a wearable device & mobile apps (or mobile medical apps) based on the FDA regulation.
There's no special system for FDA classification of specific types of devices. Provided that the device meets the Medical Device definition, it's usually classified through finding a device regulation that reads well on it or through identifying a similar device that is already cleared and "copying" its classification.

There are some guidance documents that discuss the classification of Mobile Medical Apps. A given app may be considered "not a medical device" or may, under FDA discretion, be de-facto not regulated (ie "regulation not actively enforced"). See the guidance.

Do we have to register them separately?
Most medical devices require Listing with the FDA (not registering). Whether 2 items require separate listings or can be listed as one device depends on the details, which you didn't provide.

Also, can anyone tell me if the application of Medical Device Data Systems (MDDS) is applicable for my devices?
Probably not, because you didn't provide any details.

Devices considered to be MDDS are classified in Class 1. In 2015 the FDA decided not to enforce compliance with the regulatory controls that apply to MDDS, due to the low risk they pose to patients and the importance they play in advancing digital health.

Cheers,
Ronen.
 
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