Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).