Yale University researchers say giving sponsors extended periods to complete post-accelerated approval studies may not be justified.
New research uncovers numerous software vulnerabilities in medical devices.
Medical device regulatory consultant Adrienne Lenz says FDA needs to develop a way for medical device manufacturers to transmit electronic 510(k) subm...
The Justice Department says Arthrex is paying $16 million to resolve a whistleblowers allegations of kickbacks leading to False Claims Act payments.
FDA clears a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation device designed for the clinical setting.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
Federal Register notice: FDA sends to OMB an information collection extension entitled MedWatch: The FDA Medical Products Reporting Program.
The House Oversight and Reform Committee requests information on FDAs consulting contracts with McKinsey due to potential conflicts with consulting co...