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Today, the U.S. Food and Drug Administration (FDA) has published the updated guidance Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements. At this time, based on the information currently available to the Agency, the FDA believes the devices identified in the guidance document meet the standards for exemption from premarket notification (510(k)) requirements. Until such exemption occurs, or until the FDA becomes aware of new information affecting its current understanding, the FDA does not intend to enforce compliance with 510(k) requirements for these devices. Due to this enforcement policy, the FDA does not expect manufacturers to submit 510(k)s for these devices during this time.
Exercising enforcement discretion over premarket notification requirements for these devices presents less burdensome policies for affected manufacturers of the included devices and reflects the agency’s commitment to eliminate unnecessary regulations.
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