"Shelf-Life" Class I Non-Sterile Products Expiration Date?

#1
I have a series of Class I Non-Sterile devices that a distributor is asking for an expiration date to be added to labeling and COCs. When I hear expiration date I typically think of sterility, which we have testing to support our shelf-life. So how would one determine a reasonable shelf-life or expiration date of a product that is non-sterile? I can not find any guidance save for an early nineties FDA guidance document which has not been helpful. Any standards or rationale for the hows and whys of choosing shelf life for nonsterile class one devices would be appreciated. Also, perhaps this is in fact not a requirement for these devices? We've added a manufacturing date to labeling for MDR but an expiration date rationale is escaping me.

Your help is much appreciated!
 
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monoj mon

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#2
Shelf-life does not necessarily mean only maintaining sterility, it is just one of the requirements if your device is provided 'sterile'.

From FDA's guidance document "SHELF LIFE OF MEDICAL DEVICES April 1991",

Shelf life is the term or period during which a commodity remains suitable for the intended use. An expiration date is the termination of shelf life, after which a percentage of the commodity, e.g., medical devices, may no longer function as intended. To determine if a particular device requires a shelf life and assign an expiration date, there are a number of different parameters that must be considered. The device must be analyzed to determine if it is susceptible to degradation that would lead to functional failure and the level of risk that the failure would present.

Look into your design verification report(s), is there any parameter/component that may change over the course of time! It is a best practice to determine a shelf-life even if it is a class I, non-sterile product. For example, if you have a polymeric material in your device which may degrade over the course of time and ultimately may lead to failure then you must identify that time period and address it as shelf-life.

If it is a non-sterile product, you don't need to conduct sterility-related testing. But, I would recommend you conduct the initial conditioning and shipping simulation prior to going through the aging of the test samples. At the end of each aging time point, you would need to conduct the performance testing on the test samples in order to prove that the device performs as intended.

As a standard practice, look for your competitors' products and check the shelf-life on them. You may try to establish one around that time period.

Depending on what type of device you have, there might be some standard that defines the performance requirement of your device. Follow it at every aging time point to determine the shelf-life.
 

Edward Reesor

Trusted Information Resource
#4
Note that unless there is a defined expiration date (like sterility), there is no distinction between "Use by", "Best Before", "Shelf Life", etc dates Some even have the manufacturing date and a "Use within 3 years" written somewhere. Its still rather nebulous.

Also, the ever changing list of acceptable plasticizers will alter the chemical makeup of plastics, such that they may break down faster. For example, when DEHP and DINP were in use, you would find a 5 year "expiration date". After they were banned and the search was on for an acceptable replacement, lifespan has dropped to 3 years. Or business includes components with inflatable cushions. Under the same storage and usage environmental conditions, the ability to maintain that cushion decreases.
 
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