21 CFR Part 820 - FDA Label Requirements

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
The reauirement states "
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).
"

Can internet search replace city or telephone directory in this case?
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
My opinion is that since the requirement states "current" city directory, an internet search would not be acceptable because you would be unable to provide evidence that it's current.
 

blackholequasar

Involved In Discussions
#6
It does bear some consideration -- I know that some cities, like the one I live in, are fully digitizing their city records and directories. It's a big undertaking and they're going back as far as 1827 for some records. But would that mean that, eventually, the internet would be the only place to access these items? We no longer receive a Yellow Book or White Pages; and what city directory does this reference exactly? I think the argument could be made for the internet (but maybe not just yet). It's up to some interpretation.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
Does anyone really use the Yellow pages nowadays? i dont think I have used it in a decade.
 
#8
My input may help you. I currently have a 510k submission in front of the FDA. We recently moved from CA to WA and the FDA asked me about it and commented that when they Googled us they saw the CA address and not the WA address. Easy to explain and straighten it out but my point is they use Google just like the rest of us. I haven't seen a white pages or yellow pages in print form now that it's so easy to find everything you need online.

I doubt the FDA has a current policy that allows or forbids this topic other than the old stuff. They'll put together a committee, solicit comments from interested parties, create a draft policy, wait three years and then publish the final policy and post it in the federal register. You'll have a dependable policy in 2026.
 

DonkeyKang

Starting to get Involved
#9
They'll put together a committee, solicit comments from interested parties, create a draft policy, wait three years and then publish the final policy and post it in the federal register. You'll have a dependable policy in 2026.
And by then there will be an altogether different mainstream resource for such information.
 
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