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.

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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

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