Conformity Assessment Notices and Letters to Manufacturers and Interested Parties

Updated August 18, 2021

NIOSH Respiratory Protective Device Information

Guidance documents developed to inform respiratory protective device users.

CA 2021-1038 – Revocation of Shanghai Dasheng Health Products Manufacture Co., Ltd. Approvals

CA 2021-1037 – Updated user instruction information regarding three NIOSH-approved filtering facepiece respirators TC-84A-9298, TC-84A-9308 and TC-84A-9315

CA 2021-1033R1 – Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre- market notification in accordance with the Food and Drug Administration regulations at 21 CFR § 878.4040. Supersedes March 2021 version

CA 2021-1035 – Revocation of Public Health Emergency Approval TC-84A-PH19

CA 2021-1033 – Guidance for respirator users regarding NIOSH Approved surgical N95 filtering facepiece respirators (surgical N95s) exempt from 510(k) pre-market notification in accordance with the Food and Drug Administration Final Rule published May 17, 2018

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 2018-1006R1 – 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 2021-1034R1 – Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements. Supersedes: March 2021 version

CA 2021-1034 – Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements

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

NIOSH Conformity Assessment Letter to Manufacturers

Documents formerly referred to as Letters to All Manufacturers.

CA-2021-1036 – Immediate Information for NIOSH-Approval Holders having Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, and the forthcoming NIOSH revocation of these PHE approvals

CA-2021-1032 – Effective Immediately – In response to COVID-19 – Updated NIOSH fraud and fraudulent statements policy and prioritization for accepting and examining particulate filtering respirator approval applications, including Surgical N95 respirators, submitted by existing domestic and non-domestic approval holders, new domestic manufacturers/applicants, and new non-domestic manufacturers/applicants. Supersedes NIOSH CA 2020-1031

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

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

Page last reviewed: August 18, 2021