NIOSH Conformity Assessment Letter to Manufacturers, 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). This notice has been superseded. For the latest NIOSH guidance on this topic, please see the updated notice: CA-2018-1010-R1.
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NIOSH Conformity Assessment Letter to Manufacturers, 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). This notice has been superseded. For the latest NIOSH guidance on this topic, please see the updated notice: CA-2018-1010-R1.

  • 11/15/2018

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  • Description:
    Beginning December 1, 2018, the National Institute for Occupational Safety and Health (NIOSH) will accept applications to implement the coordinated regulatory process to exempt a subset of filtering facepiece respirators (FFRs) from Food & Drug Administration (FDA) premarket notification requirements. The N95 FFRs and data provided by the applicant must demonstrate.
  • Document Type:
    Report
  • CIO:
    NIOSH
  • Division:
    NIOSH_NPPTL
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