Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.