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The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures.
The Centers for Medicare & Medicaid Services (CMS) said it may not provide reimbursement for vagus nerve stimulation (VNS) for treatment-resistant depression because there is insufficient evidence the treatment is "reasonable and necessary."
The FDA sent the Craftmatic Organization a warning letter for failing to handle and report product complaints, but the company said it should not have received the letter because it did not manufacture the devices.
The FDA is requesting nearly $2.1 billion as part of the president's fiscal 2008 budget -- a more than 5 percent increase over the budget submitted to Congress last year, according to agency.
The FDA has cleared the first genetic multivariate index assay, a diagnostic that reads multiple pieces of genetic information, to determine the probability that patients suffering from early-stage breast cancer will have a recurrence of the disease in five to 10 years.
The American Association for Homecare has posted a safety alert notice on its website from oxygen cylinder manufacturer Catalina notifying the firm's customers about potential problems with a valve one of its device models.
The FDA has announced the availability of proposed and final documents prepared by Study Groups 1, 2 and 4 of the Global Harmonization Task Force (GHTF).
When deciding which type of FDA marketing application to submit, device firms should consider the possibility they may have to defend themselves against civil, or "tort," lawsuits if their products are linked with patient injury, legal experts told attendees at an FDAnews audioconference last month.