Link to find 502 (f)(1) which is quoted several times in 21 CFR 820

#1
I am trying to find 502 (f) (1); quoted several times in 21CFR820,
just one example below:

[FONT=&quot]
Medical devices having commonly known directions[/FONT]
801.116
[FONT=&quot]A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.[/FONT]
Does anyone have a link to 502 (f) (1) please?

Thank you in anticipation

J0anne
 
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MIREGMGR

#2
Re: Link to 502 (f) (1)

*** DEAD LINK REMOVED ***

Old link was: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108061.htm
 
Last edited by a moderator:

rothlis

Involved In Discussions
#4
The link posted in the answer on this thread is no longer valid but I think I figured this out, so I wanted to put what I've found here in case anybody else tries to sort this out. Please let me know if I got any of this wrong.

1. There isn't anything between 501.110 and 502.5 in the CFR. Clearly the reference is to something else.
2. A search for "502(f)(1)" reveals FDA warning letters which cite 502(f)(1) but then put 21 USC 352 in parenthesis. USC = United States Code.
3. The USC lists sections 501 - 517 as having been repealed in 1970.
4. The parenthetical reference to 21 USC 352 in the warning letter is valid and discusses misbranded drugs and devices.
5. Section 352 of the CFR discusses requirements for sunscreen. Clearly not applicable.

So, given the context, I'm fairly certain that the references to 502(f)(1) in the CFR can actually be taken as references to 21 USC 352(f)(1), which states that "A drug or device shall be deemed to be misbranded unless its labeling bears adequate directions for use".

You'd think that a body who requires traceability in our design and production records could at least try to maintain traceability in their laws.
 

Ronen E

Problem Solver
Moderator
#6
Not a problem at all.

"Section 502" relates to the FD&C Act ("the act", as referred to in the regulations) as it was originally enacted. Later the act was codified in USC, and s. 502 became s. 352.

The FDA website holds a mapping.
 

rothlis

Involved In Discussions
#8
Not a problem at all.

"Section 502" relates to the FD&C Act ("the act", as referred to in the regulations) as it was originally enacted. Later the act was codified in USC, and s. 502 became s. 352.

The FDA website holds a mapping.
That certainly helps, but I still think they've done a poor job handling this. Are they not synchronizing the numbering between the act and the code because the 5xx references are already too deeply ingrained elsewhere? Even new legislation references the 5xx act number and they frequently don't refer you to the corresponding 3xx code number where you would actually have to look to figure out what they're talking about. It definitely isn't user friendly.
 

Ronen E

Problem Solver
Moderator
#9
That certainly helps, but I still think they've done a poor job handling this. Are they not synchronizing the numbering between the act and the code because the 5xx references are already too deeply ingrained elsewhere? Even new legislation references the 5xx act number and they frequently don't refer you to the corresponding 3xx code number where you would actually have to look to figure out what they're talking about. It definitely isn't user friendly.
You'll have to refer those questions (why...) to a USA legal expert, because I'm not.

The FD&C Act is long codified in the USC, and that's where anyone should look for the current FD&C Act text. By convention, all references to "the act" in the device-related regulations are to the FD&C Act as amended. The webpage I linked to provides both the mapping and the actual USC text, though it might not be the most up-to-date text. Once you know the USC section you could go directly to the source. See more details here.

It may not be the most user friendly, but I think it's reasonable. We don't need the Act's actual text on a daily basis, do we?

Cheers,
Ronen.
 
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