The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
Category Archives: Food Safety News
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
Thomas Produce Recalls Cucumbers because of Possible Health Risk
Thomas Produce Company of Boca Raton, FL is recalling 174 bulk-packed containers of Cucumbers. This product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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American Pure Whey Issues Allergy Alert on Undeclared Milk and Soy in Whey Protein Products.
American Pure Whey, New Bern, NC is recalling all lots distributed from 7/2015 to 09/2015 of the products 100% Pure Whey Protein Matrix and 100% Pure Whey Protein Isolate, because they may contain undeclared milk and soy that are present in the whey ingredient. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life threatening allergic reaction if they consume these products.
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FDA approves Zurampic to treat high blood uric acid levels associated with gout
The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.
FDA approves new orphan drug to treat pulmonary arterial hypertension
On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply
Today the U.S. Food and Drug Administration issued a final guidance outlining updated donor deferral recommendations that appropriately protect the U.S. blood supply by reducing the risk of transmitting human immunodeficiency virus (HIV) infection.
FDA permits marketing of fecal continence restoration system
The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
FDA proposes tanning bed age restrictions and other important safety measures
Today, the U.S. Food and Drug Administration announced important proposed steps to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.