Talk:Federal Food, Drug, and Cosmetic Act of 1938

510(k) section

I added a clean up tag because much of the text in there at the beginning is a plagiarism of one of the references; It is US federal gvt text so no copyright issue; The whole section is actually ambiguous, if not just wrong; I'll try to have a look time permitting. --MarmotteiNoZ 01:38, 21 February 2011 (UTC)

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One error in the 510(k) section that jumped out at me was the definition of substantial equivalence. The article says that one must show SE to a device on the market before 1976. That's not exactly true. There is a second pathway: show SE to a legally marketed device that does not require a PMA. For example, this AED 510(k) pre-market notification cites two other AEDs as SE predicates.

Here is text from that PDF that the FDA uses when issuing 510(k) clearance: “We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).”

I would recommend that the article cite the Institute of Medicine which recently published slides about the history of the 510(k) process and more generally how it works.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Reviewing a 510(k) submission

510(k) history from 1976 to 2010

FDA's 510(k) working group

In particular, slide 20 of the 510(k) history shows class I and class II (non exempt) devices are required to use the 510(k) process. The wikipedia entry seems to imply that the class I devices only need general controls and not 510(k). That's somewhat true, but general controls can include 510(k) premarket notification. I'd recommend redoing the classification list based on FDA documentation

Kevinfu-bread (talk) 04:01, 27 February 2011 (UTC)Kevin Fu

Untitled

• 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). —-

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)

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. DanaUllman^Talk 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)

Food Color; Certified colors

Pigments from natural sources are exempt from FDA certification. All pigments are subject to rigorous standards and testing natural and artificial... Does that seem contradictory to anyone else ? — Preceding unsigned comment added by 68.185.51.214 (talk) 17:29, 6 April 2013 (UTC)

Removed section on "GMOs as Food Additives"

The source was broken, although I appear to have chased down a version here:

http://webharvest.gov/peth04/20041016021502/http://www.foodsafety.gov/~fsg/fssyst4.html

It doesn't appear to state in any way what was stated in the article, which is that all GMO crops were approved as Food Additives. The document is also really ancient (2000) and doesn't appear titled as the link indicated.

I can't find any reference to support the assertion of the removed text, but if someone can find one, don't hesitate to put it back with a proper source. 12.208.4.65 (talk) 14:37, 30 July 2014 (UTC)

How rigorous is the FDA in protecting consumers from harmful products?

This article could be improved by including any form of a discussion on how rigorous the FDA is in enforcing the "unsafe ingredients" part. Some ideas:

• As in https://en.wiki.x.io/wiki/Toxic_Substances_Control_Act_of_1976#2013, discuss the number of products removed from market and some reasons they were removed
• Discuss state regulations to fill in gaps. What did some states do?
• Discuss company liability in more detail. Have there been court cases where companies or the FDA were fined for allowing a product on the market that was unsafe?
• Carcinogens in products - data on chemicals known to the State of California under Prop 65, or considered by IARC, to be carcinogenic & found in products? This is more interesting & important for food, drugs, and cosmetics because we're not expecting a lot of acute effects (burning skin, etc) from products consumers buy to eat or apply to their bodies, but long-term or chronic effects are harder to individual consumers to assess, which is where regulations come in. Same goes for the next bullet
• Endocrine or reproductive effects of chemicals listed by the EU, etc?
• Comparison to EU regulations. Is FDA considered to be more rigorous or less rigorous? We could highlight specific products or chemicals that are allowed in one regulatory schema and not allowed in another.

Reradford (talk) 21:22, 29 November 2015 (UTC)

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