We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has signed a memorandum of understanding (MOU) with the Department of Veterans Affairs (VA) under which the two agencies will share information and expertise related to the review and use of devices, drugs and biologics.
FDA investigators found that Apple Medical's procedures regarding its gynecologic electrocautery devices violated several current good manufacturing practice regulations, the agency said in a warning letter.
After looking into charges by a former Medtronic employee that the firm had overlooked safety issues regarding one of its heart devices, the FDA has reportedly found nothing to indicate the product is unsafe.
HemoSense's medical devices are adulterated due to current good manufacturing practice violations regarding its complaint handling and investigating system, an FDA warning letter said.
Sen. Robert Byrd (D-W.Va.) and Rep. Dave Obey (D-Wisc.), the respective leaders of Senate and House appropriations committees, announced Jan. 29 an agreement on the final federal funding package for the current fiscal year.
The FDA learned through Hardy Diagnostics' recent voluntary recall of its HardyCHROM O157 device that the company was marketing the device without approval, an agency warning letter said.