FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ROBOTICALLY-ASSISTED SURGICAL DEVICES-PREMARKET SUBMISSIONS; DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Sept. 25 -- Food and Drug Administration has issued a notice called: Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Sept. 25 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices-Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically-assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation ...