510 (k) submission timeline

Furkan A.

Registered
Hi at all.

I have question regarding a 510(k) submission.

1. is it possible to start the 510(k) submission without doing the full shelf life test? If we assume that the shelf life of the device is 3 years, but we only do an accelerated aging of 1 year, with the idea of starting the submission as soon as possible. At the same time, we are working on Acc. Aging for 3 years. Or does it not make sense as it will only bring more problems and queries from the FDA.

Thank you!
 

chriseng

Registered
Hi Furkan,

Short answer is yes it is possible to submit, long answer is it depends.
The main point to examine is, are you only extending the shelf life (without physically changing anything) or are you changing anything related to the packaging or device? If you are only extending the shelf life because you wanted to get something on the market quicker that should be no problem. A lot of companies choose this approach since as you pointed out the testing and aging can take a long time.
The following is from the FDA Guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (B4.1 p. 27):
"Generally, changes in device packaging or changes in the expiration date for use of a device do not require submission of a new 510(k)."
In the case where you fall within this category of not requiring a new 510(k) you would need to either file a Special 510(k) with the change in shelf life or you could create a Letter-to-File with the appropriate documentation of the change in shelf life.

Note that you still need to perform real-time aging testing for your 1-Year time point, even if you are trying to move to the 3-year aging.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
FDA accepts Arrhenius testing in submissions so long as real time aging is also being done and the QMS reflects this. Expect FDA to ask about the real time testing if they audit you.
 
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