NIOSH Conformity Assessment Letter to Manufacturers, 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

Details

• Description:
  Beginning August 24, 2020, the National Institute for Occupational Safety and Health (NIOSH) will accept applications to implement the coordinated regulatory process to exempt a subset of single-use disposable N95 filtering facepiece respirators (FFRs) from Food and 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-512:54f8ebb1a579f3b3e6df9da92a2bdf31238631d0686a8fd9954edaa3bb65510047e9c45c9aedff502667076945168b23acadf3e75466a6dfc32f9cecb48f5443
• Download URL:
  https://stacks.cdc.gov/view/cdc/137541/cdc_137541_DS1.pdf
• File Type:
  [PDF - 406.69 KB ]