Conformity Assessment Notices and Letters to Manufacturers and Interested Parties

Updated June 25, 2020

NIOSH Respiratory Protective Device Information

NIOSH Conformity Assessment Notice

NIOSH Conformity Assessment Interpretation

NIOSH Conformity Assessment Letter to Manufacturers

Documents formerly referred to as Letters to All Manufacturers.

CA-2020-1030 – Requirements and Responsibilities of Approval Holders and Assignees in NIOSH Approved Respirator Private Labeling and Private Packaging Arrangements

CA-2020-1029 – Clarification about U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUA) Applicable to Existing NIOSH Respirator Approval Holders

CA-2020-1027 – Effective Immediately – In response to COVID-19 – NIOSH is accepting and prioritizing particulate filtering respirator approval applications submitted by existing approval holders and new domestic manufacturers/applicants. Supersedes NIOSH CA 2020-1024

CA-2020-1025 – Effective immediately – NIOSH Approval Letters, Denial Letters, and Final Fee Invoices will be signed electronically

CA-2020-1024 – Effective immediately – NIOSH is prioritizing Respirator Approval Applications in response to COVID-19

CA-2019-1023 – Revised Chemical Warfare Agent (CWA) Test Fees, Fee Collection Process, and submission Requirements for NIOSH CBRN Respirator Approvals, effective January 1, 2020, this notice supersedes NIOSH CA 2018-1009 and the NIOSH Letter to All Manufacturers dated August 22, 2014

CA-2019-1022 – Interim Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supplements CA-2019-1018 and 1021

CA-2019-1021 – Interim Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supplements CA-2019-1018

CA-2019-1018 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals

CA-2019-1015 – Resolution to Issue Affecting Gas and Vapor Testing for NIOSH Respirator Approvals, supersedes NIOSH CA 2019-1014

CA 2019-1014 – Issue Affecting Gas and Vapor Testing for NIOSH Respirator Approvals

CA 2018-1010 – Interim guidance regarding applications for NIOSH Approval of Filtering Facepiece Respirators in accordance with the Food and Drug Administration (FDA) Final Order published May 17, 2018, and FDA/NIOSH MOU 225-18-006, dated November 2017 (included as a reference in this notice)

CA 2018-1009 – Revised Chemical Warfare Agent (CWA) Test Fees for NIOSH CBRN Respirator Approvals, effective October 10, 2018, this notice supersedes NIOSH Letter to All Manufacturers dated August 22, 2014

CA 2018-1008 – Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supersedes NIOSH CA 2018-1001

CA 2018-1001 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals

NIOSH Conformity Assessment Meeting

Below are letters issued to respirator manufacturers and letters issued to all interested parties:

Page last reviewed: June 25, 2020