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 This notice has been superseded.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.

Details

• 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
• NIOSHTIC Number:
  nn:na
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:2b36a750b92ced43684f5db07597a9d1b04c885965599274947e94c312ee544043f0aa7af5b17dbe5f64be50ca86e23238c12225d0de70f20a59b6bd8e44a28c
• Download URL:
  https://stacks.cdc.gov/view/cdc/137540/cdc_137540_DS1.pdf
• File Type:
  [PDF - 359.06 KB ]