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
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