Conformity Assessment Letters to Manufacturers

Conformity Assessment Letter to Manufacturers

• CA 2024-1078 – Temporary Delays in Applications that Require Human Test Participants
• CA 2023-1062 – Information and Responsibilities of NIOSH Approval Holders for Nonconforming Respirator Investigations (NRIs)
• CA 2023-1061 – Effective Immediately — NIOSH Respirator Approval Program Returns to Conventional Operations. This notice supersedes NIOSH CA 2022-1040
• CA 2023-1058 – Effective Immediately — Revocation of Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, Supersedes NIOSH CA 2022-1045
• CA 2023-1056 – NIOSH fraud and fraudulent statements policy and information about the NIOSH Respirator Approval Program certification marks. This notice supersedes NIOSH CA 2022-1041-R1
• CA 2022-1050 – Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals
• CA 2022-1041-R1 – Effective Immediately – NIOSH fraud and fraudulent statements policy and new information about using NIOSH marks. This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2022-1041 and NIOSH CA 2021-1032
• CA 2022-1045 – Updated Information for NIOSH-Approval Holders having Public Health Emergency (PHE) Approvals issued during the COVID-19 Response, and the NIOSH action to obsolete (phase out) these PHE approvals. Supersedes NIOSH CA 2021-1036
• CA 2022-1041 – Effective Immediately – NIOSH fraud and fraudulent statements policy and new information about using NIOSH marks. This notice and NIOSH CA 2022-1040 supersede NIOSH CA 2021-1032
• CA 2022-1040 – Effective Immediately – Prioritization of applications submitted by existing domestic approval holders and new domestic applicants for new approvals or extensions-of-approval for particulate filtering respirators, including Surgical N95 respirators. This prioritization does not include private-label requests. This notice and NIOSH CA 2022-1041 supersede NIOSH CA 2021-1032
• 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 20CA 2019-1021 – Interim Resolution to Issue Affecting Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals, supplements CA-2019-101819-1021 – 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