Shelf Life Requirement for Class II Medical Device

B

Biobry

#21
Thanks, I should have been more specific. Our device is a wound dressing containing a silver antimicrobial. The product code for these devices is technically "unclassified", but is most commonly treated as Class II. In the past we have submitted accelerated aging data and noted that real-time aging is in process and would be completed according to the same protocol. It has not been difficult in the past to justify the use of accelerated aging data for these devices.

A requirement to develop the product then sit on it for at least another year in order to have enough data to submit for a decent shelf life claim seems like it would be a barrier to new start-ups especially in a highly competitive market.

At this point we are hoping that it is as you said, a miscommunication or misunderstanding between our consultant and FDA, but I am very rarely surprised anymore.
 
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M

MIREGMGR

#22
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...
The legacy 510(k) requirement for sterile devices, in my experience, has been that the submission includes accelerated aging data supported by a rationale for validity of the accelerated aging technique; and a statement that real time testing has commenced, along with a schedule for when periodic evaluations will be performed and a commitment that if the real time aging is not consistent with the accelerated aging data out to the stated product life, the claimed product life will be changed to match the real time data and prior-marketed product will be corrected.
 
M

MIREGMGR

#23
Our device is a wound dressing containing a silver antimicrobial.
All of my comments here have been in regard to my experience with CDRH. Your product, as I currently understand the rules, is a Combination Product and will be handled by the Office of Combination Products, not CDRH. FDA's handling of combination products is known to have changed substantially in the past several years. As such, I don't know what rules will be applied or how it will be examined, so my prior comments are invalid in regard to your product.
 
A

Adele

#24
We have experienced a recent influx of requests for shelf life information from the FDA in our 510(k)s despite never having to produce this information previously and our competitors not having a shelf life.

As a matter of course we now submit our 510(k)s with a shelf life or a well-documented justification for no shelf life. It has been incorporated into our design process so it is clear from the beginning that it needs to be addressed.

We have successfully used a risk management approach and look at the critical features of the device and the potential for them not to work after degradation from sitting on the shelf. We already had a Duration of Use labelled so I am sure that helped in this approach.

The shelf life we proposed was long enough that we felt that it wasn't a significant issue for a single-use product.

But I suspect every reviewer and every division is different with regard to what they will accept.
 

Mark Meer

Trusted Information Resource
#25
As a matter of course we now submit our 510(k)s with a shelf life or a well-documented justification for no shelf life.
...
We have successfully used a risk management approach and look at the critical features of the device and the potential for them not to work after degradation from sitting on the shelf. We already had a Duration of Use labelled so I am sure that helped in this approach.
Curious: when was the last time such an approach worked for you? Don't get me wrong, it makes perfect sense. ...I was just under the impression that the FDA was moving away from accepting claims of "infinite" shelf life (i.e. no shelf life).

But I suspect every reviewer and every division is different with regard to what they will accept.
Sadly, by all accounts - and from the mouth of our own inspector -this is definitely the case... :(
 
S

SamMX

#26
We have experienced a recent influx of requests for shelf life information from the FDA in our 510(k)s despite never having to produce this information previously and our competitors not having a shelf life.

As a matter of course we now submit our 510(k)s with a shelf life or a well-documented justification for no shelf life. It has been incorporated into our design process so it is clear from the beginning that it needs to be addressed.

We have successfully used a risk management approach and look at the critical features of the device and the potential for them not to work after degradation from sitting on the shelf. We already had a Duration of Use labelled so I am sure that helped in this approach.

The shelf life we proposed was long enough that we felt that it wasn't a significant issue for a single-use product.

But I suspect every reviewer and every division is different with regard to what they will accept.
Hi Adele,

As a matter of course we now submit our 510(k)s with a shelf life or a well-documented justification for no shelf life. It has been incorporated into our design process so it is clear from the beginning that it needs to be addressed.


How did you address thus in your design process?
Stability Testing is part of your design verification or validation?

Please share your comments.

Thanks in advance.
 

Ronen E

Problem Solver
Staff member
Moderator
#27
Hi Adele,

As a matter of course we now submit our 510(k)s with a shelf life or a well-documented justification for no shelf life. It has been incorporated into our design process so it is clear from the beginning that it needs to be addressed.


How did you address thus in your design process?
Stability Testing is part of your design verification or validation?

Please share your comments.

Thanks in advance.
Hi SamMX, welcome to the discussion :bigwave:

You are replying to a post from 3.5 years ago. Adele has not logged in here in almost 2.5 years.

If stability tests are run it would imply to me some intended shelf life, because any stability test has a finite duration. I am guessing that a "no shelf life" claim would be based on a scientific rationale rather than on testing (or with the aid of some auxiliary testing, but not traditional stability testing).

FWIW.
 
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