Conformity Assessment Notices and Letters to Manufacturers and Interested Parties

NIOSH Respiratory Protective Device Information

Guidance documents developed to inform respiratory protective device users.

CA 2020-1028 – Information regarding damaged or degraded head straps on previously stockpiled NIOSH-approved filtering facepiece respirators

CA 2020-1026 – Information regarding Shanghai Dasheng Health Products Manufacture Co., Ltd. (SDH) filtering facepiece respirators (FFRs) with ear loops and labeled as NIOSH-approved

CA 2018-1006-R1 – Self-contained breathing apparatus (SCBA) user information regarding compressed breathing gas containers (cylinders), NIOSH approval holder user instructions, and Department of Transportation (DOT) permit and marking. Revised: Supersedes the August 2018 version Additional information: Pipeline and Hazardous Materials Safety Administration Notice: DOT Special Permit 16320external icon

CA 2018-1006 – Self-contained breathing apparatus user information regarding compressed breathing gas containers (cylinders), NIOSH approval holder user instructions, and Department of Transportation (DOT) permit and marking

NIOSH Conformity Assessment Notice

Document developed to provide information to NIOSH approved respirator users (formerly called user notices), to inform stakeholders about changes in a test procedure or the NIOSH CA process, revocations (formerly referred to as letters to interested parties). The document developed to reaffirm a NIOSH CA process or procedure.

CA 2019-1016 – Summary of the Federal Register comments concerning the Department of Transportation Special Permit 16320 Additional information: Pipeline and Hazardous Materials Safety Administration Notice: DOT Special Permit 16320external icon

CA 2019-1012 – NIOSH Respirator Approval Contents and Meaning, Supersedes: March 17, 2006 Respirator User Notice – Meaning of NIOSH Approvals May 15, 2015 Letter to All Respirator Manufacturers – NIOSH Respirator Certificate of Approval, Approval Labels and User Instructions

CA 2018-1003 – NIOSH Use of a Personal Computer (PC) Based System, Microsoft Windows and National Instruments’ LabVIEW™ Data Acquisition Software to replace use of the Gould RS3200 Strip Chart Recorder beginning June 15, 2018

CA 2018-1002 – Intra-Laboratory Comparison of LabVIEW™ Data Acquisition Software to replace use of the Gould RS3200 Strip Chart Recorder

NIOSH Conformity Assessment Interpretation

An explanation of a course of action or position adopted and pursued by NIOSH/NPPTL that directly affects its stakeholders such as interpretations of and changes to the respirator approval process or requirements.

CA 2019-1019 – Effective Immediately – NIOSH quality control plan requirements

CA 2019-1017 – NIOSH acceptance of breathing gas cylinders marked in accordance with 49 C.F.R. Part 178 and ISO 11119-2

CA 2019-1013 – NIOSH labeling requirements for air-purifying and powered air-purifying respirators, effective March 1, 2019. Supersedes the July 19, 1995 Letter to All Respirator Manufacturers

CA 2019-1011 – NIOSH Respirator Approval Program’s use of the NIOSH Bivariate Panel during Isoamyl Acetate Fit Testing beginning February 1, 2019, Supersedes: May 18, 2005 Letter to All Respirator Manufacturers

CA 2018-1005R1.0 – NIOSH Respirator Approval Program’s updated position regarding facial hair and the selection and use of respiratory protective devices. Revised – Supersedes the August 2018 version and the October 2, 2006 Letter to All Respirator Manufacturers

CA 2018-1005 – NIOSH Respirator Approval Program’s updated position regarding facial hair and the selection and use of respiratory protective devices, Supersedes October 2, 2006 Letter to All Respirator Manufacturers

NIOSH Conformity Assessment Letter to Manufacturers

Documents formerly referred to as Letters to All Manufacturers.

CA-2020-1031 – Effective Immediately – In response to COVID-19 – UPDATED NIOSH prioritization for accepting and examining particulate filtering respirator approval applications, including Surgical N95 respirators, submitted by existing approval holders, new domestic manufacturers/applicants, and new international manufacturers/applicants. Supersedes NIOSH CA 2020-1027

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 2018-1010R1.0 – 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). Revision Supersedes the November 2018 version

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

A meeting announcement to advertise date, time and attendance instructions for interested parties.

CA 2019-1020 – Meeting with Respirator Manufacturers, October 29, 2019, 9:00 AM – 4:00 PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

CA 2018-1007 – Meeting with Respirator Manufacturers, October 17, 2018, 9:00 AM – 4:00 PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room or by Adobe Connect

CA 2018-1004 – Meeting with Respirator Manufacturers, August 7, 2018, 9AM – 2PM EST, NIOSH Pittsburgh Facility, Building 140 Multipurpose Room

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