De Novo Classification Request

FDA Sets Design and Marketing Considerations for Over-the-Counter Medical Devices

The U.S. Food and Drug Administration (FDA) explains the regulatory and design standards that manufacturers of over-the-counter medical devices should consider, from usability and labeling to clinical evidence and connected software. It also explains when a new 510(k), De Novo request, or PMA application may be required when converting a device from prescription use to direct-to-consumer use.