Medical Devices; Protective Restraints; Revocation of Exemptions From the 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulations

The Food and Drug Administration (FDA) is revising the classification regulations for protective restraints and wheelchair accessories intended for use as restraints, by revoking the existing exemptions for these devices from premarket notification and current good manufacturing practices (CGMP) regulations. FDA is also modifying the classification regulations for protective restraints and for wheelchair accessories to clarify the definitions of these devices. FDA is taking these actions in response to a number of recent reports of deaths and serious injuries that may have been associated with improper supervision of restrained patients or improper application of protective restraints. FDA believes that these actions will have minimal economic effect and will not disrupt the supply of these devices. In a notice published elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document for the preparation of premarket notification (510(k)) submissions for protective restraints.