FDA Class 1 recall for two medical devices



A method of producing synthetic bone, using techniques normally used to make catalytic converters for cars, is being developed by researchers at WMG at the University of Warwick. The team is now working closely with Warwick Ventures, the University’s technology transfer office, to find a suitable partner to help commercialise the technology, and will be presenting

Full Post: New method of producing synthetic bone

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

“These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “One of the FDA’s primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”

Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency’s November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.

HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion’s first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

http://www.fda.gov

Link




Caraco Pharmaceutical Laboratories, Ltd. announced today that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008. In the warning letter, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008. As previously disclosed, the warning letter was issued as a follow

Full Post: Caraco Pharmaceutical Labs responds to FDA warning



The U.S. Food and Drug Administration has announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. Wilderness Family is a manufacturer and distributor of conventional

Full Post: FDA announces permanent injunction against Wilderness Family Naturals



Medicsight PLC has announced the submission of a 510(k) Premarket Notification to the United States Food and Drug Administration (FDA) for clearance to market its ColonCAD(TM) image analysis software throughout the U.S. Submission of the 510(k) notification enters Medicsight into a FDA review process. Successful clearance of the product will enable the Company to access

Full Post: Medicsight seeks FDA 510(k) clearance to market ColonCAD software in the U.S.



As part of the U.S. Food and Drug Administration’s ongoing efforts to ensure that heparin for patients remains safe, the government seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request

Full Post: FDA seizes Heparin from Cincinnati manufacturer



Salix Pharmaceuticals, Ltd. has announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. Based on its review, the FDA has determined that

Full Post: Salix Pharmaceuticals receives FDA response for Balsalazide tablet