Shelf Life Requirement for Class II Medical Device

M

MIREGMGR

#11
I think the current view is that an evidence-based life is required, and a rationale for why an evidence-based life should not be required is not acceptable.

Why don't you ask your examiner if he/she would accept such a rationale?
 
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U

USCTrojan83

#12
I have. Unfortunately my lovely reviewer hasnt responded in 5 business days since she sent the RTA.:bonk:
 
M

MIREGMGR

#13
Five days is nothing. I have one problematic application at present for which I waited for a requested and agreed teleconference for four months.
 

Mark Meer

Trusted Information Resource
#15
I don't know if I've got any concrete advice, but I can certainly chime in with my own experience...

We submitted a 510(k) last year for a Class II, and the reviewer had the same issue.

I went through the exact same trains of thought:
- "...but none of the nearly identical product currently on the market are labelled with a shelf life..."
- "...here is our evidence to back up the product life stated in the 510(k)..."
- " ...there is absolutely no risk to the user even if materials were to degrade (rationale provided)..."

In the end, it was futile. We finally added a statement of shelf life to the label...which to this day I find ridiculous. It has yet to be seen whether this will just confuse end-users into mistakingly thinking the device is volatile and might somehow "go bad". :confused:
 
U

USCTrojan83

#16
We submitted a 510(k) last year for a Class II, and the reviewer had the same issue.
Thanks Mark. Do you mind me asking what type of device is it? Im beginning to swallow the fact of running accelerated studies just to get it done with.
 

Mark Meer

Trusted Information Resource
#17
It's an accessory actually: essentially just a remote control with a few buttons and an LED.

When's the last time you saw a shelf-life on a remote-control label? Never? ...my thoughts exactly... :bonk:
 
B

Biobry

#18
I appreciate reading through everyone's comments here, as this has helped. We are getting ready to submit a 510(k) soon for modification to a current device (material change). We had performed all of our accelerated aging according to our protocols just like we had done in the past, but our consultant just told us that the FDA is no longer accepting accelerated aging only for the basis of your shelf-life justification. We realize that Real-time aging must be completed also, but have always submitted accelerated with the inclusion of a statement or protocol to be done for the real-time aging to back up the accelerated aging.

Has anyone else heard of this recent change in thinking within the FDA? I realize this is slightly off of the original topic, but seemed to fit in the discussion.
 
M

MIREGMGR

#19
Has anyone else heard of this recent change in thinking within the FDA?
I haven't, specifically, and of course you haven't said what regulation and product classification you're discussing and that likely is determinative, but such a change would be consistent with other changes that definitely have occurred.

For instance: FDA's overall approach to review of drapes and covers has changed substantially in recent years, becoming more literal in regard to the language in guidances and also more literal in regard to the specific language of the underlying regulation. This makes 510(k) assembly harder. It also interestingly narrows the scope of the defined product classes compared to the legacy approach, prior to say five years ago.

I would think that a requirement for real time evidence of product functionality over the full rated shelf life would be very impractical for many product types. An imaging system, for instance, might have a stated functional life of fifteen years.

Is it possible that there's a communications or understanding issue between FDA, the consultant and yourself, and instead the shift for your particular product type is to a more rigorous rationale for why the selected accelerated-aging means is technically appropriate and validated in that regard...?
 

Mark Meer

Trusted Information Resource
#20
Has anyone else heard of this recent change in thinking within the FDA? I realize this is slightly off of the original topic, but seemed to fit in the discussion.
Not off topic at all! In fact, I think it very much sums up the root cause: the FDA's current practices/expectations are unclear.

We realize that Real-time aging must be completed also...
I don't think this is the case. I can't imagine that they'd mandate real-time aging evidence. For anything with a shelf-life greater than a few months to a year, this would severely hinder businesses...
 
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