Philadelphia associate Caitlin McHugh and San Francisco partner Matthew Smith authored an article for Law360 titled “FDA Streamlines 510(k) Process, As Courts Reconsider It.” The article begins with an overview of the FDA’s “Quik Review Program Pilot” and its purpose, which is to promote more efficient and consistent review for Class II medical devices. The attorneys go on to explain a trend of federal cases that are eroding the misconception that Section 510(k) review and approval does not include an FDA finding of safety and effectiveness and the implications for punitive damages claims brought against manufacturers of Class II devices.

Source: Law360