Medical Devices companies in USA

In the warning letter, the U.S. Food and Drug Administration this year, medical device companies urged to ensure that the provided online information, such as keywords and other metadata not deviate from the therapeutic indications which are on record for the specific products to the Authority.

End of January 2013, the FDA has a warning letter to a manufacturer of nutritional supplements, Medical Doctors Research , shipped, is cited in the that some of the allegations made ​​in the marketing material breach of its products to the U.S. Federal Food, Drug and Cosmetic Act. The U.S. agency criticizes not only some explicit marketing the manufacturer in online descriptions, but also, interestingly, specific keywords like "cancer" and "diabetes" in the product search box on the website. The search results, the FDA warning letter, indicate that some of the company's products that prevent or treat these diseases.

FDA monitoring of online marketing of <strong><a href=medical device companies" width="210" height="210"> A second manufacturer of nutritional supplements, Nature's Health Supply , received a similar warning letter from the FDA in July 2013. The letter indicated that several meta tags on the company's search engine optimization website (SEO) - such as "cancer", "diabetes" and "cholesterol" - suggesting that the company's products for the treatment of these diseases and conditions are used, although they have not been tested with respect to such purposes by the FDA.

Although these cases do not involve medical devices, this warning letter from the FDA act on medical device manufacturers with regard to online marketing and product information. All aspects of online marketing of medical device manufacturers, even such innocuous issues such as meta tags and SEO strategy should be closely linked to the purpose and the therapeutic indication claims that the FDA 510 (k) clearance or approval prior to launch (Premarket Approval PMA) are specified for the product, because the U.S. authorities apparently also monitor online activities.

Share this information with others:


buy levitra on line
BiblioGov To provide incentives for pharmaceutical, biotechnology, and medical device companies to invest in research and development with respect to antibiotic ... treat, or prevent life-threatening diseases.
Book (BiblioGov)
2008-11-26 10:26:52 by stache

Part 2 -

“In a nonapproved case, it’s essentially a little research project going on because we don’t know if these tissues and structures in that area are going to behave in the same way as the tissue the device was approved for,” said Stephen Li, the president of Medical Device Testing and Innovations of Sarasota, Fla., a company that develops materials for medical implants and a consultant to the F.D.A. panel.
Patients aren’t always aware that treatments they are having are off-label. The F.D.A. prohibits companies from marketing unapproved uses. Representatives from Allergan, Medicis, BioForm Medical (the maker of Radiesse) and Artes Medical (the maker of ArteFill) said they did not promote off-label uses

2007-09-08 13:16:15 by ---------

Chip implants shown to cause cancer, f

-
Late last year, Albrecht unearthed at the Harvard medical library three studies noting cancerous tumors in some chipped mice and rats, plus a reference in another study to a chipped dog with a tumor. She forwarded them to the AP, which subsequently found three additional mice studies with similar findings, plus another report of a chipped dog with a tumor.
Asked if it had taken these studies into account, the FDA said VeriChip documents were being kept confidential to protect trade secrets

2007-09-10 11:01:46 by BabyKanuk

And again

When the FDA approved the device, it noted some Verichip risks: The capsules could migrate around the body, making them difficult to extract; they might interfere with defibrillators, or be incompatible with MRI scans, causing burns. While also warning that the chips could cause "adverse tissue reaction," FDA made no reference to malignant growths in animal studies.
Did the agency review literature on microchip implants and animal cancer?
Dr. Katherine Albrecht, a privacy advocate and RFID expert, asked shortly after VeriChip's approval what evidence the agency had reviewed

You might also like:

Idea to IDE: A Medical Device in the Making
Idea to IDE: A Medical Device in the Making
Cleaning Validations for Newly Manufactured Medical Devices and
Cleaning Validations for Newly Manufactured Medical Devices and ...
What makes the Mantis stereo inspection microscope so special?
What makes the Mantis stereo inspection microscope so special?

Veteran voices caution for women in the military  — Press Pubs
She signed up to become a medic because she had a bit of prior medical training as a lifeguard and it sounded more exciting than other options such as working in a kitchen or an office. After training she was sent to a small ..

Fueling the entrepreneurial spirit  — Harvard Gazette
HMS student Marc Succi, who recently founded a medical device company, said the entrepreneurial spirit is also alive and well among the student body at the Medical School.

SC Launch Company - KIYATEC
SC Launch Company - KIYATEC
Master Caster Company Cord Away® Adjustable Grommet, 2 3/8 diameter, 1/Pack (MAS00202)
Office Product (Master Caster Company)
  • Cable Management Type - Grommet
  • Catalog Publishing Type - Cable Management-Channels, Clips Grommets
  • Color(s) - Black
  • Coupon Cannon - 03-13-09
  • Diameter - 2 3/8 in
BiblioGov To provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with ... antivirals, diagnostic tests, and vaccinnes.
Book (BiblioGov)
Kemp USA Rescue Tube Cover
Lawn & Patio (Kemp USA)
  • Multipurpose device may be thrown to a swimmer or used for towing.
  • Quick-release Delrin buckles, with a 12 in. strap extension that quickly wraps around any swimmer.
  • Made of vinyl-dipped Ensolite that is soft and forever buoyant.
  • Connects to a heavy-duty 6 ft., polypropylene tow line for added safety.
  • 37-in. x 6 1/2-in. x 3 1/2-in.

Related posts:

  • Avatar Investigator X How different is it to get approval from Health Canada vs the FDA for drugs and medical devices?
    Nov 29, 2006 by Investigator X | Posted in Skin Conditions

    I am interested in learning more about the approval process for drugs and medical devices in Canada vs the USA. New and emerging companies would benefit from this.

    • In Canada, everything has to go through a rigorous testing process before it can be released to the public, but you can get generic versions of drugs much sooner than in the USA; I think it s twenty years after proprietary version is released.

  • Avatar Carlos Why does the USA spend more on healthcare than any other country and they have the poorest health outcomes?
    Jul 02, 2013 by Carlos | Posted in Current Events

    On average, people live about 5years longer in Japan than people in the USA. They spend half of what the USA spends on healthcare. Is it the american culture? Is it poor doctors? I think it is a combination of poor doctors and the american culture. I have visited too many doctors who have recommended expensive, unnecessary medications and medical devices. In the USA, eating out is not equated with eating healthy.

    • We have a great health care systemWe have a country unlike any other country in the world that gives everyone the same rights to go to school and get an education and to better yourself in your future , if you choose not to get that education who s fault is this ? I know many people in the city of Detroit who have been raised by a crack head mother in the 80 s and one is now a Doctor and I know 2 of them who are Lawyer s .and so many turned out to be Police officer s ,.so to use the Problems of the Urban areas and Family issues are just an excuse. Stop being lazy and get of your ass and go to school …

  • Avatar Jonah Why are some Americans not grateful towards Israel?
    Jun 28, 2012 by Jonah | Posted in Politics

    I seen many comments from Liberals and people who are probably Ron Paul supporters. Saying that they think Israel is not a true ally of the USA. How ridiculous is it to think that. Israel does a lot for the USA. Even more than what USA does for Israel. Israel is really the only true friend the USA has. Israel sends the best intelligence out their when it comes up to spotting terrorism. @display your the troll. Your the one that once said that Israel did terror attacks on America. @jason your answer is borderline anti-Semitic.

    • The foriegn aid the USA provides to Israel is 2,835.8 million, that s $385.62 per person. 1.3 percent of Israel s GDP is American aid. When you say &quot;Israel does a lot for the USA. Even more than what USA does for Israel. Israel is really the only true friend the USA has.&quot; I think 3 things: 1. You cannot do math. The nation of Israel provides exactly $0.00 foriegn aid to the USA. 2. You report &quot;Israel does a lot for the USA.&quot; You seem to forget that US support for Israel has caused the USA to be targets for Islamic terrorists. 3. You are extremely naive to …