Manufacturers can submit summary information instead of the underlying data.
Manufacturers may provide summary reports showing adherence to device-specific guidance documents in order to demonstrate safety and effectiveness. The Safe Medical Devices Act introduced the idea of using special controls to ensure the safety and effectiveness of devices. Special controls include performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other actions that provide assurance of safety and effectiveness. Also, FDA advocates the use of device consensus standards to prove safety and effectiveness. Manufacturers may submit declarations of conformity to standards to ensure compliance.