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ariannas

#1
OK, I admit to getting hung up in the details here...

I'm using the FDA website to look at 21 CFR 807.3(j):
"(j)Classification name means the term used by the Food and Drug Administration and its classification panels to describe a device or class of devices for purposes of classifying devices under section 513 of the [FD&C] act."
I was curious what section 513 in the FD&C act actually said, so I went hunting for it in the 2011 version of the United States Code as published on the GPO website.

Looking at 21 USC 9, which is where the FD&C Act resides, I find that section 513 does not exist. But based on context, I can tell that section 360c. Classification of devices intended for human use. is most likely the correct section.

Why the discrepancy in section numbers?

I understand that section numbers can shift over the years, but what's the logic of _not_ updating these references in the CFR? The CFR gets updated annually anyway...

(eagerly awaiting the day that I can post links... sigh)
 
#2
OK, I admit to getting hung up in the details here...

I'm using the FDA website to look at 21 CFR 807.3(j):
"(j)Classification name means the term used by the Food and Drug Administration and its classification panels to describe a device or class of devices for purposes of classifying devices under section 513 of the [FD&C] act."
I was curious what section 513 in the FD&C act actually said, so I went hunting for it in the 2011 version of the United States Code as published on the GPO website.

Looking at 21 USC 9, which is where the FD&C Act resides, I find that section 513 does not exist. But based on context, I can tell that section 360c. Classification of devices intended for human use. is most likely the correct section.

Why the discrepancy in section numbers?

I understand that section numbers can shift over the years, but what's the logic of _not_ updating these references in the CFR? The CFR gets updated annually anyway...

(eagerly awaiting the day that I can post links... sigh)
You're confusing the FD&C Act Section Number and the Title Section Number.

The full correct designation of this section is Sec.513.[21 U.S.C. 360c]
 
A

ariannas

#3
You're confusing the FD&C Act Section Number and the Title Section Number.
Hmmm. Is there a place online where one can look at a current version of the FD&C Act in "act" format rather than "Title/USC" format? I've only been able to find the latter.
 
#4
Hmmm. Is there a place online where one can look at a current version of the FD&C Act in "act" format rather than "Title/USC" format? I've only been able to find the latter.
I'm very sure there would be. I haven't checked.

EDIT: A quick Google pulled this up, where these references are seen in use:

http: // www. fda .gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

It's mentioned in a whole bunch of places.
 
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A

ariannas

#6
I finally found the mapping to from FD&C act section numbers (which are typically what is cited in regulations and older guidance) to the section numbers in 21 USC and actual statute text.

http: // www .fda .gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

This solves the mystery for me. Thanks to all who contributed.
 
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#7
Nicely done.

Without a doubt, this is one of the most poorly laid-out websites I've seen. It shouldn't have been that hard. Coming close is our Transport Canada website; hard to find info on it unless you already know where it is.
 

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