Department of Health and Human Services May 17, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the 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. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a guidance entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' The guidance is intended for institutions and IRBs responsible for review and oversight of human subject research under the Department of Health and Human Services (HHS) and FDA regulations. The purpose of this guidance is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated August 2016.