New Medical Device Accessory with New Function - Is this a major change?

Mark Meer

Trusted Information Resource
#1
We'd like to introduce a "fitting kit" disposable accessory that clinicians can use to test out on patients to see if the device is suitable for individual patients.

I'm not clear how the addition of such an accessory would affect the regulatory status (510(k) cleared, CE marked, Canadian MDL). Not sure if it's a major change.

Ultimately, when used for treatment (i.e. if clinician determines the device is a good fit, and issues prescription), there is no change to the way the device is used.

However, with the "fitting kit" accessory (to be used exclusively for assessment purposes by a clinician), the device IS used slightly differently (as the intent is to get an optimal fit, and assess the effectiveness). The patient will never use the "fitting kit" accessory.

So, is this a major change? Can a distinction in intended use be made between the setup as used for assessment purposes (clinician directed) versus patient treatment purposes (after the device is actually prescribed). What would be the regulatory considerations/implications?

Any input/advice much appreciated!
MM
 
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isolytical

Involved In Discussions
#2
See the FDA guide 'Deciding When to Submit a 510(k) for a Change to an Existing Device'. For the accessory, there will be a new use - 'For Professionals only'.
 

Mark Meer

Trusted Information Resource
#3
See the FDA guide 'Deciding When to Submit a 510(k) for a Change to an Existing Device'. For the accessory, there will be a new use - 'For Professionals only'.
This is what is not clear to me. Is it a new use? The device itself (when prescribed) is not "For Professionals Only". When used for the therapy it's intended for, the device use has not changed. When used for assessment purposes (with use of the accessory, by a clinician), the way it is used is quite different.

One way to consider it is that the device:
- With the accessory the intended use is as an assessment tool to be used by clinicians to assess if patients are good candidates for treatment with the device.
- Without the accessory then intended use is as a treatment device to be used by patients.
 

isolytical

Involved In Discussions
#4
"One way to consider it is that the device:
- With the accessory the intended use is as an assessment tool to be used by clinicians to assess if patients are good candidates for treatment with the device.
- Without the accessory then intended use is as a treatment device to be used by patients."

Yes, this is correct thinking and also the 'why' there are two 'uses'. Also see the MDD, which makes a clear distinction/definitions for the two concepts. If you are having serious doubts about the path forward call the FDA, the person concerned will gladly answer questions.
 
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