Device Shelf Life Extension to 48 months without involving the FDA

image182

Involved In Discussions
Hi all,

I have small questing related to the shelf life of a device.

Reviewing current and draft guidance documents, its fairly clear that we can change the expiration date of the device by documenting the evidence internally.

Current Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (1997)
B9: Change in packaging or expiration dating --> Yes --> Documentation

Draft Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (2019)
B4: Is there a change in packaging or expiration dating? --> Yes --> B4.1: Is the same method or protocol, described in previous 510(k), used to support change --> Yes --> Documentation

Therefore, for example, if we gain 510(k) clearance for a device with a 12 month shelf life, if we had appropriate data we could expand the shelf life by e.g. 6 months by documenting this internally and not involving the FDA.

I'm wondering to what extremes this could be taken? Would it be possible to gain clearance for a device with a 1 month shelf life. Then expand the shelf life to 48 months without involving the FDA?

The reason i'm asking is that if we're gaining clearance on a device using accelerated aging data, the 510(k) review time and the shelf life study could be run in parallel and result in us getting the device to market a lot sooner. e.g.
  • gain a data for a short shelf life
  • Submit the 510(k)
  • Wait e.g. 200 days for the completion of the shelf life study and the clearance of the device
  • Document the change for the shelf life internally for the planned long shelf life
  • Launch the device

Thanks for your help!
 

JeantheBigone

Quite Involved in Discussions
My gut feeling is "no."

First of all, change in shelf life / expiration date is a modification which according to FDA may require a new 510(k).

https://www.fda.gov/MedicalDevices/...sions/PremarketNotification510k/ucm134575.htm

With that, the answer to this question is firmly in the grey area.

However, FDA thinking is that there are reasonable shelf lives for different devices.

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466475.pdf

So a 510(k) for a device that typically has a shelf life of five years but only claims a shelf life of one month would probably raise the reviewers' eyebrows. :rolleyes: I doubt it would get cleared without a discussion about the unusually short shelf life. FDA is not known for wanting manufacturers to take things to extremes. :)

Once the device is cleared, FDA leaves it to the manufacturer to decide whether a new 510(k) is needed or not. If you can justify and document that safety and effectiveness are not affected, then you can extend the shelf life. The risk you take is that FDA may disagree.
 
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