Blogs #Medical Devices
What is a premarket approval (PMA) application?
A premarket approval (PMA) application is the most stringent type of device marketing application for medical devices.
What are examples of medical devices?
Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. A longer list of examples of medical devices is in the FDA Information Sheet Guidance, “Significant Risk vs. Non-Significant Risk Devices.”