FDA Days - What is the FDA definition of FDA Days

Dramirez

Starting to get Involved
#1
I have looked everywhere (or sort of) and could not find a definition for FDA days...can anyone tell me what an FDA day is?...that is, how does FDA count days?

Thanks
 
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AnaMariaVR2

Trusted Information Resource
#2
Re: FDA days? what does it mean?

Not sure if this helps.

Calendar Date - Format 2

Can you be more specific? FDA days or FDA count day in what sort of context? Related to what? The response can be different based on the situation...as for example when companies have 15 days to respond in writing to the FDA after a 483 is issued.

Are you referring to the FDA's review clock?:confused:
 
2

20130523

#3
It is usually referred to as the amountof time a submission is taken to review, numbered in Days.
 

Dramirez

Starting to get Involved
#4
Re: FDA days? what does it mean?

Yes I am refering to review clock. While the documentation reads "in 180 days", "90 days" and so on, all of them refer to a so called "FDA day" and not sure what that menas...working days (exclude weekends and holidays)? calendar days?

Thanks
 
L

lynchoid - 2012

#5
Re: FDA days? what does it mean?

The FDA operates on "calendar days," and counts weekends and holidays.
 

Ajit Basrur

Staff member
Admin
#6
The term "FDA days" refers to the amount of time a submission is under review by FDA and does not include the time when the clock has been stopped. This is one of the 510 (K) performance goals which they have stated for themselves.

I have attached a copy of "FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment" and you will find more details in that document.
 

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