Dental Devices; Effective Date of Requirement for Premarket Approval of Over-the-Counter (OTC) Denture Cushions or Pads and OTC Denture Repair Kits

Streszczenie

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for OTC denture cushions or pads and OTC denture repair kits. The agency is also summarizing its findings regarding the benefits to the public from use of the device, as well as, the degree of risk of illness or injury intended to be eliminated or reduced by requiring that the devices have an approved PMA or a completed PDP. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of the device based on new information.