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Is a specific day required in an expiration date?

#1
The CFR states the following relating to the expiration date of a medical device:

"Sec. 801.18 Format of dates provided on a medical device label.

(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02."

My question: is it required that a specific day of the month be included in an expiration date? This clearly shows the format, but is it saying the day MUST be included? Or is this saying that if a day is used, go with YYYY-MM-DD, or--if no day is specified--just go with YYYY-MM?

Thanks!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day Steve,

In my view, the CFR Part A, 801.18 requirement is specific in requiring a date to include day of the month.
 

Ninja

Looking for Reality
Trusted
#3
I'm not in medical...but the instruction seem pretty clear as you've presented them in quotes.

the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens.
I don't see how you could comply with that (other than pressing on the title "In general") without including the day.

HTH
 

Ninja

Looking for Reality
Trusted
#6
Mindset change needed...

You read a regulation approved by a governing authority...and you ask WHY? Don't do that...life will be much easier for you.

If you are on the counsel drafting the regs...ask "Why?" several thousand times. But if you're just on the receiving end...don't do that.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
Practical approach: Where only a month is specified, it usually means the last day of the month. So just define in your internal procedures that you always specify the last day of the month - 2019-08-31, then 2019-09-30, etc. - and validate to the worst case.
 
#8
I do agree, questioning will drive a person to drink! And I normally just go with it and don't ask why...but this one increases risk without any benefit that I can see. How many products have been discarded prematurely because of confusion over the expiration date (some would read 12-01 as January 12th and others would say Dec 1st)? If I go with the 15th of the month, as I understand some are doing, I'm essentially cheating the end user out of half a month. And while we essentially use Ronen's approach, that method introduces the risk of a fairly serious non-conformity: 31 could be used for a month that only has 30 days (so we use the 28th of the month just to be safe). I agree with Ronen that if the day isn't specified, it's logical to assume it's the end of the month, so I feel like I'm missing the reasoning behind why that wasn't used when this was drafted.
 
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