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Sites running clinical trials for devices should document all adverse events and investigators’ responses even if they don’t ultimately report the events to regulators or Institutional Review Boards, a contract research organization executive told the MAGI clinical research conference in San Diego last week. Read More
The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls. Read More
The FDA has released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
Canada’s Medical Technology Companies association said it strongly supports the Canadian government’s plans to change the country’s complex regulatory, reimbursement and procurement process for medtech. Read More
In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination. Read More
Failure to establish a design history file for its Pocket Protector breast implant pouch, landed the Beverly Hills practice of breast augmentation surgeon Mark Berman a 15-item 483 following a July 7 to July 13 FDA inspection. Read More
Failure to report a voluntary recall to the FDA landed Respire Medical an FDA Form 483 following an April 24 to May 2 inspection at its Brooklyn, New York facility. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
The FDA cited Richard Wolf Medical Instruments for CAPA and complaint procedures following a June 26 to July 17 inspection of the company’s Vernon Hills, Illinois facility. Read More
Validation and CAPA failures were among quality system failures uncovered during a Feb. 26 to March 1 FDA inspection of Pega Medical’s Quebec facility. Read More