Medical Devices; Revocation of Exemptions from Premarket Notification for Certain Cardiovascular and Physical Medicine Devices

概要

The Food and Drug Administration (FDA) is withdrawing in part its proposed rule that published in the Federal Register of November 12, 1998 (63 FR 63222), to revoke the exemptions from the requirement of premarket notification of a cardiovascular device (cardiopulmonary bypass accessory equipment) and a physical medicine device (electrode cable). Elsewhere in this issue of the Federal Register, FDA is issuing a final rule to exempt other devices from the requirement of premarket notification.