Medical devices are categorized based on risk associated with usage of the device. The categorization is based on the following parameters:
The general regulatory controls The special regulatory controls The need of premarket approval (PMA)
What are general controls for medical devices?
General controls are fundamental provisions to ensure the safety and effectiveness of regulatory devices. It includes provision for adulteration, misbranding, device registration, notifications for repair/replacement or refund, premarket notification, records & reports, and good manufacturing practices.
What are special controls for medical devices?
Special controls are additional controls to general controls for reasonable safety and usability assurance, which includes specific labeling such as usage methods, guidelines, recommendation etc.; performance standards; post-market monitoring; patient registration and more.
