Zdrowie i gospodarka · 4.03.1996
Medical Devices; Protective Restraints; Draft 510(k) Guidance Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for the preparation of premarket notification (510(k)) submissions for protective restraints and wheelchair accessories intended for use as restraints. The draft guidance document is intended to assist manufacturers in complying with premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule revoking exemptions for these devices from premarket notification and current good manufacturing practices regulations.