FDA

FDA Consent Decree Halts Most Sales of Infusion Pump

The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt.
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FDA Launches Home-Use Medical Device Pilot Program

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member.
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Insurance Carriers Push for Stronger Regulations on Medical Devices

An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing.
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Nationwide Recall for Compounded Drugs from North Carolina Pharmacy

A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down. Compounded Drug Recall
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Holes in FDA Testing Process Lead to Flawed Designs

There has been substantial media attention and reaction from affected patients regarding metal-on-metal hip implants over the last decade or so. Of course, one of the most famous examples is the articular surface replacement, or ASR, implant which was manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Tens of thousands of the devices were implanted in patients before injuries, immobility, and even metal poisoning led to their recall in 2010.
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New FDA Guidelines for Reusable Medical Devices

In an effort to increase safety and prevent disease, the United States Food and Drug Administration (FDA) released new recommendations regarding reusable medical devices. The announcement from the FDA was made following an outbreak of a bacterial superbug linked to the design of a specific piece of reusable medical equipment.
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More Foodborne Illness Caused By Produce than By Meat or Eggs

Most Americans recognize the potential dangers of undercooked meat or raw eggs. In fact, many restaurant menus carry warnings that beef cooked less than well-done may place the diner at elevated risk for foodborne illness. While the concerns over meat, eggs, and often dairy products, are certainly based in fact, government research indicates that, more than any of these, fruits and vegetables represent the largest source of foodborne illness in the United States.
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Enrollment Process Open in Mass Tort Stryker Settlement

It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted.
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FDA Approves New Obesity Device

In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It’s the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes.
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Lupron Can Result in Serious Injury or Death

Lupron is a hormonal regulator that has several dangerous, if not oft-publicized side effects of which every patient should be aware. The drug is prescribed to help slow early-onset puberty in teenagers, to men who exhibit signs of prostate cancer, and to help treat women with endometriosis, a rare condition in which the lining of the uterus grows outside the actual uterus. According to the U.S.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com