Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices

In the Federal Register of July 25, 2001 (66 FR 38786), the Food and Drug Administration (FDA) amended its medical device classification regulations for class I devices to specifically add a reference to the general limitations on exemptions from premarket notification requirements from each generic device classified as exempt in each section. As published, an exemption from the premarket notification requirements and a reference to the general limitations language was inadvertently added to 12 device classifications that should not include the reference. These devices are not exempt from the requirements of premarket notification. This document corrects those errors.