Comment from Mitchell Berger
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Summary: Mitchell Berger, writing in a private capacity, provides several specific suggestions to improve the draft guidance, including clarifying the intended audience and the distinction between medical and occupational uses. He also advocates for increased coordination between the FDA, NIOSH, and OSHA, and suggests moving toward a unified, performance-based regulatory framework for respirators.
Dear Dr. Takai: I write to make the following suggestions about the above FDA draft guidance. Clarify the guidance’s intended audience(s); Add a section of guidance focused on “Role of NZJ Respirators in Public Health Preparedness”; Specify if FDA is exercising enforcement discretion with respect to NZJ/21 CFR 880.6260 devices; Clarify distinctions between medical and occupational use; Consult with the Occupational Safety and Health Administration (OSHA); Discuss FDA-NIOSH Coordination in the guidance and broaden the MOU; Move toward a unified, performance-based NIOSH/FDA framework. Please note that the opinions expressed are mine alone and not those of an agency, organization, or other individual(s). Full comment attached. Sincerely, Mitchell Berger