Talk:Federal Food, Drug, and Cosmetic Act
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- The following discussion taken from Talk:510k following merge of 510k into this article (merge occured while this discussion was still underway). --ShaneNZ 13:15, 14 January 2007 (UTC)
Although not quite an advert within Wikipedia, the link in the last section (to http://www.fdanews.com/wbi/cds/2637-1.html) is a link to an ad selling "how to do a 510(k) in 20 hours for $500". I would not consider this a creditable source. --ShaneNZ 20:25, 11 January 2007 (UTC)
I see nowhere that states "How to do a 510(k) in 20 hours for $500." Could you tell me where the source states that?
Regardless, there is also a journalistic article that states the same information. However, it is only accessible to subscribers of the newsletter. Given that most Wikipedia readers are not subscribers to FDAnews newsletters (I'm guessing), I chose instead to link to the other page.Jlculp 23:22, 12 January 2007 (UTC)
- The wiki article does not say that - it states "on average, 20 hours" and links to an advertorial for a transcript that says it will inform you how to prepare a 510(k) in 20 hours (I use the word advertorial due to the fact it does not offer advice on 510(k)'s, but lists credentials, a price and three order now links: I see no information in that link that tells how or why 510(k)s take 20 hours, or how the link author knows that 510(k)'s take 20 hours). In my experience, a 510(k) will take more than 20 hours to prepare, and I suspect that somebody faced with their first 510(k) reading the article as it currently stands will be somewhat misled, and spend $410 trying to understand how it is only 20 hours.--ShaneNZ 12:17, 14 January 2007 (UTC)
The penultimate sentence I do find odd, if it is such a simple procedure why would it take 20 hours to do? Contradicts itself.
- a 510(k) is a clearance for a relatively complicated (Class II) medical device, so 20 hours would be extremely fast and $500 would be extremely cheap. Class II devices include most diagnostic tests, automated microbiological testing systems, anesthesia equipment, cardiac catheters, etc... —Preceding unsigned comment added by Somedumbyankee (talk • contribs) 22:08, 17 December 2007 (UTC)
If I am right in my understanding, could this link not just be deleted. Ive read the article and saw no other problems with it --PrincessBrat 22:09, 12 January 2007 (UTC)
- Supported. I would like to remove the link and the statement of the average time taken for a 510(k). I don't see that it adds anything to the article.--ShaneNZ 12:17, 14 January 2007 (UTC)
In the medical device marketing world, 20 hours to ready a device for marketing (which can bring in a company many millions of dollars) is not much at all--a PMA takes over 1,200 hours, on average.Jlculp 23:22, 12 January 2007 (UTC)
Note: article edited to use correct term "substantial equivalence" rather than "substantially similar". --ShaneNZ 12:17, 14 January 2007 (UTC)
I don't think any of this discussion matters anymore--the link is broken now. I think the section should be deleted or merely state that most devices use the 510(k) procedure (remove the assertion that it's easy and takes 20 hours). —-
[edit] Dietary Supplements
The FDCA has a section on dietary supplements giving the FDA limited control over their labeling, etc. Shouldn't this be mentioned.
- It could be, but the FD&C Act covers a huge variety of products, many of which are controversial. It would be difficult to fit it all into one article. Frankly, the certified colors and device approval sections of this should probably be their own articles. It's mostly a question of how much of this is relevant to a "general interest" work like Wikipedia.Somedumbyankee (talk) 23:43, 18 December 2007 (UTC)
[edit] Author of the Act
It is notable that the author and primary sponsor of this important act was the Senator from New York, Royal S. Copeland. Copeland was not simply a politician but also a physician, and more precisely, a homeopathic physician. Strangely enough, this fact is not mentioned here, and it is notable. Before I added something about this, I thought I would first mention it here. Any comments? Amongst many other important consumer rights provisions of this law, it also gave legal recognition of the U.S. Homeopathic Pharmacopeia. By the way, a relatively new biography of Copeland is also worthy of reference: Natalie Robins, Copeland's Cure: Homeopathy and the War Between Conventional and Alternative Medicine. New York: Knopf, 2005. DanaUllmanTalk 04:17, 4 March 2008 (UTC)
- I'm not really sure how important it is overall. The majority of homeopathic drugs are created by and used in the practice of (homeopathic) medicine and are not subject to the terms of the Act since they aren't commerce, though FDA's use of the Commerce Clause is often more creative than some are comfortable with. There are health fraud concerns, but those are possible with just about everything covered by the FD&C Act. It's an interesting historical note, but it doesn't make a whole lot of difference in how the Act is implemented, especially since the section on drugs has been heavily modified since it was first implemented. The 1938 Act had no effectiveness requirements, just safety, and the safety of what is essentially water was not a major concern. GMPs apply, so contamination and sterility issues were covered.
FDA's current policy on homeopathics is essentially analogous to that on dietary supplements. As long as they're clearly labeled as homeopathic and they don't make fraudulent claims they're largely ignored as harmless. Worthless, perhaps, but not ordinarily fraudulent because there is no intent to defraud. It's not a major public health problem.
One comment questioned the FDA Consumer as V&RS, it's a magazine published by FDA, so it would be difficult to see it as an unreliable source for information about FDA-related legislative history.Somedumbyankee (talk) 05:46, 13 March 2008 (UTC)
