Knowing is half of the battle.

The Diagnostic Proces

https://www.ncbi.nlm.nih.gov/books/NBK338593/

Edible Mushrooms: Improving Human Health and Promoting Quality Life

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320875/

Surgical Masks – Premarket Notification [510(k)] Submissions

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions

https://www.fda.gov/media/71660/download

A Suggested Approach to Resolving Least Burdensome Issues removed from FDA Database.

Scope

The scope of this document is limited to the following devices described in 21 CFR §878.4040(b) class II, product codes:

FXX Surgical Mask
MSH Surgical N95 NIOSH certified Respirator

Surgical Mask

A surgical mask covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. The surgical masks referenced in this guidance document include masks that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without a face shield.

Surgical Respirator “N95 NIOSH Certified”

A surgical respirator is fitted to the user’s face, forming a seal that provides a physical barrier to fluids, particulate materials, and aerosols. If you wish to label your device “N95 NIOSH Certified,” please refer to the (NIOSH) website at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/ for information about NIOSH’s Certification Program Support for Respirator Manufacturers.

New SearchHelp | More About 21CFR

[Code of Federal Regulations][Title 21, Volume 8][CITE: 21CFR878.4040] TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H – MEDICAL DEVICESPART 878 — GENERAL AND PLASTIC SURGERY DEVICESSubpart E – Surgical DevicesSec. 878.4040 Surgical apparel. (a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. (b) Classification.  (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption: (i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.(iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.[53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000; 83 FR 22848, May 17, 2018]

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4040

Assessing hazards and determining the needs for respiratory protection

Expanded occupational use recommendation: Establish comprehensive workplace exposure standards with indicators for hazards (such as wildfire smoke) to trigger respiratory protection program requirements, including for those workplaces in which respirators would not otherwise be required.

Public use recommendation: Establish and use a standardized process for determining the public’s need for respiratory protection.

Determining the Necessary Respiratory Protective Devices

Expanded occupational use recommendation: Recommend only NIOSH-approved respirators for workers without respiratory protection programs facing inhalation hazards when other forms of control (e.g., engineering, administrative) fail to protect them.

Public use recommendation: Use hazard and risk evaluations to determine the necessary respiratory protective devices for the public.