Non-sterile Medical Device Shelf-Life

[SallyOV]

Hi,

We are developing a non-sterile Class II medical device. This device is a reusable, single-patient-use device that undergoes very basic cleaning. I feel a little lost regarding the following topics:

1. Is it necessary to define a shelf life for this type of medical device (i.e., non-sterile medical devices)?
2. Regarding device lifetime, my approach is to define it based on the number of reprocessing cycles. Am I on the right track?
3. I am a bit concerned because, after reviewing the IFU of the predicate device, I do not see any mention of device lifetime or reprocessing cycles. I thought this was a requirement for reprocessed devices.
4. My understanding is that we are required to demonstrate that the medical device maintains its performance and safety throughout both the shelf-life period and its defined lifetime. Therefore, we plan to conduct bench testing at different time points. Am I on the right track?

Thank you for your help!

 

[planB]

ad 1: in case your device has safety or performance characteristics that you anticipate deteriorating over time in a non-verifyable way, then defining a shelf life may be reasonable.

ad 2: yes, this might be one option.

ad 3: this could have several reasons, such as:
- the predicate device is that old that device lifetime was generally not considered in instructions for use
- the predicate device is verifiable in its safety and performance characteristics by the user

ad 4: yes, this might be one option. FDA's guidance on reprocessing gives you the following two choices - screenshot from p.20:

HTH,

 

[EmiliaBedelia]

1) Personal experience here: for EU MDR, my notified body required us to define a shelf life for a reusable Class IIa device in the EU which already has a use life (defined based on use cycles with inspection criteria AND test procedure specified to assess performance). Personally I don't think FDA is as concerned with shelf life for reusable devices if you have a reasonable justification but my NB was very insistent on having objective evidence for the shelf life.

Your device might be different from mine such that you can better justify why a shelf life is not required, but you should document it. You especially need to consider storage conditions as this could impact device lifetime as well as shelf life.
Bonus consideration here: check with your operations/manufacturing group on your warehouse conditions!! if you label your device for storage at room temperature but your warehouse is not climate controlled, you will have an NC waiting for you in an audit.

2) This depends on your device characteristics. "Use cycle" including reprocessing may be a better approach - if your device will be under stress during its use cycle then you should cycle it to that many uses. You should also consider whether a user will be able to realistically keep track of use cycles over the device lifetime. Another option would be to estimate a "worst case" number of uses per year and then cycle based on that.

3) As mentioned above, the IFU and predicate could be old, the reviewer might have missed it, they may have additional labeling that is provided with the device, they may have an incompetent labeling group... Predicate devices offer helpful info, but don't base your entire regulatory approach on your competitors.

4) Correct. "use life" and "shelf life" prior to first use are distinct from each other.