A
ariannas
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):
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)
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)