Non-Sterile Class 2 Medical Device Shelf Life


Jim H

We produce a class 2 medical device that we have been under ICH guidelines for our stability and shelf life determinations. Our product contains an aerosol with no drug or active ingredient. We have looked into sterile medical device stability guidelines (ANSI/ISO 11607) to extend our expiry date from 2 to 3 years. We have the real time data to do that. My question is, is there another protocol like 11607 that addresses non-sterile medical devices?


I assume from the terminology of your post that you're asking about US FDA regulation.

Any such standard or guidance would be specific to the clinical function of your device.


you may want to have a look a this FDA guidance doc:

Shelf life of Medical Devices

Agreed, though that 1991 content is pretty basic stuff. Presumably the International Conference on Harmonization reference was to newer-than-23-year-old guidance.

FDA does have a few device-type-specific guidances that might apply to the subject device, depending of course on what it is.


Can the expiration date of a non-sterile, non-invitro medical device be extended after it is already in the market. A customer purchased our device ( a non-sterilizing filter) that had an expiration date of 12 months but they have not used the device and it only has 1 month of dating remaining. We have data that supports 24 months on file. Can we send them a letter that the date has been extended?


Super Moderator
Would a related shelf-life extension be a change that you would have to report / submit / register to/with regulatory bodies in the market of your customer prior to implementation? If yes, you may want to refrain from sending a "dear customer" letter until you have received approval. For example, this FDA page illustrates the US procedure for shelf life extension of Covid-19 in-vitro diagnostics.

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