Another regulatory draft guidance released last week seeks to clarify what is, and what is not, an accessory to a regulated medical device.
Your iPhone isn’t a regulated medical device. This and other insights are available in the new draft guidance: “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.”
According to the definitions in the draft guidance there are three types of accessories:
- Support: provides assistance to the primary operation of the parent device
- Supplement: adds new functionality to the operation of the parent device
- Augment: allows the operation of the parent device more safely or effectively
The summary of this 12 page draft guidance seems to be: “if an accessory helps a device it needs to be approved, but it might be an easy Class I or Class II approval if it’s not risky.” (We’re not regulators, this does not constitute legal advice, you need to get independent guidance if you’re looking to make an accessory. -Ed.)
The other nugget is that platforms that enable medical devices, such as a computer monitor or a smartphone, are not medical device accessories unless they are marketed specifically for that purpose.
For healthcare marketers considering apps this means two things:
- If you are creating an app that is intended to work with an existing medical device, say a piece of hardware like an insulin pump or even a mobile medical app, you need to review the app to see if it falls into the FDA’s definition of an accessory. If it does, you will need to get it approved but it may not be as onerous as you might fear.
- If any of the platforms available are deemed medical devices you will need to review this guidance to see if your app is considered an accessory. This will most likely not be an issue, but LG recently acquired a 510(k) certification for a cardiovascular sensor and so did Samsung for its S Health app so any apps that use those sensors will need to be reviewed against this guidance to see if they are considered accessories.
This draft guidance really is just a long definition of the term “accessory” and to the untrained eye it seems pretty straightforward. Readers are encouraged to talk with their regulatory groups about what this means for their mobile app plans. (You do have mobile app plans, yes? -Ed.)
Source: FDA Draft Guidance