Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while additional time is 

provided for participants to join the call. 

Please connect to the audio portion of the webinar now:

U.S. Callers Dial: 888-455-1392

International Callers Dial: 1-773-799-3847

Passcode: 7621596
NIOSH-Approved Surgical N95 

Filtering Facepiece Respirators

Colleen Miller, BS

Deputy Chief, Conformity Verification and Standards Development Branch 

National Institute for Occupational Safety and Health (NIOSH)

National Personal Protective Technology Laboratory (NPPTL)

September 1, 2020
Contact Information - NIOSH Reviewers 

Ms. Heidi Sewchok, MS

Approval Coordinator

National Institute for Occupational 

Safety and Health

National Personal Protective Technology 

Laboratory

Conformity Verification and Standards 

Development Branch

Pittsburgh, PA

Email: Hsewchok@cdc.gov

Ms. Ashley Whitson, MS

General Engineer (Biomedical)

National Institute for Occupational 

Safety and Health

National Personal Protective Technology 

Laboratory

Conformity Verification and Standards 

Development Branch

Pittsburgh, PA

Email: Awhitson@cdc.gov
Where does NPPTL fit into the federal 

structure?

HHS

CDC

NIOSH

Div/Labs

Department of Health and Human 

Services

Centers for Disease Control and 

Prevention

National Institute for Occupational Safety and 

Health

NIOSH Divisions/Labs

National Personal Protective Technology 

Laboratory (NPPTL) 
NIOSH Divisions & Laboratories

• Office of the Director, NIOSH

• Division of Field Studies & Engineering (DFSE)

• Division of Safety Research (DSR)

• Division of Science Integration (DSI)

• Division of Compensation Analysis and Support (DCAS)

• Health Effects Laboratory Division (HELD)

• National Personal Protective Technology Laboratory 

(NPPTL)

• Office of Extramural Programs (OEP)

• Pittsburgh Mining Research Division (PMRD)

• Respiratory Health Division (RHD)

• Spokane Mining Research Division (SMRD)

• Western States Division (WSD)

• World Trade Center Health Program Division (WTC)
NIOSH 

approves all

respirators 

used in U.S. 

occupational 

settings.
Surgical N95 filtering facepiece respirators (SN95) 

Healthcare settings

 Occupational Safety and Health Administration (OSHA) requires that 

respirators used in occupational settings are NIOSH approved

 Respirators used in healthcare are considered medical devices by the 

FDA, cleared through the 510(k) premarket notification program

 Previously, all N95s used in healthcare had to obtain NIOSH approval and 

then FDA clearance. 

 2016 National Academy of Medicine workshop

 2017 Memorandum of Understanding (MOU) with NIOSH and FDA

 2018 NIOSH guidance and process for executing the MOU

 2020 NIOSH updates guidance for SN95 approval
Today’s webinar is on the 

updated NIOSH guidance 

posted August 2020: NIOSH 

approval for Surgical N95 

filtering facepiece respirators 

*November 2018 guidance 

referred to these respirators as 

“N95-Fs”
Revised guidance 

announced NIOSH is 

accepting SN95 

approval applications 

as of August 24, 2020

https://www.cdc.gov/niosh/npptl/resources/press

rel/letters/conformitymanuf/CA-2018-1010-

R1.html
NIOSH posted the 

third prioritization 

notice on August 24, 

2020, to include SN95 

applications

https://www.cdc.gov/niosh/npptl/resources/pressr

el/letters/conformitymanuf/CA-2020-1031.html
 Designs or controls the respirator design 

 Manufactures, assembles, or controls the 

assembly of a respirator

Applicant for NIOSH Approval
Four specific scenarios 

NIOSH CA 2018-1010R1

 No immediate action under this guidance is required for an existing device that has 

previously obtained NIOSH approval and FDA 510(k) clearance.

 If a manufacturer of an existing NIOSH-approved N95 FFR has not previously sought 

FDA 510(k) clearance and now seeks to label a device with the additional protections

(flammability, fluid resistance, and biocompatibility), the manufacturer must follow the 

guidance to achieve a NEW NIOSH approval for the SN95 respirator. 

 If a manufacturer of an existing NIOSH-approved N95 FFR has not previously sought 

FDA 510(k) clearance and does not seek to label this device with the additional 

protections (flammability, fluid resistance, and biocompatibility), the existing NIOSH 

approval will remain effective.

 If a manufacturer of a new N95 FFR seeks NIOSH approval for a Surgical N95, the 

manufacturer must follow the guidance. 
How to achieve SN95 FFR Approval

 Step 1: Perform pre-submission testing

– Inhalation resistance, exhalation resistance, particulate filter efficiency

–Additional tests that must be performed at a GLP certified laboratory 

› Fluid penetration 

› Flammability

› Biocompatibility 

oCytotoxicity

oSensitization

oIrritation 
How to achieve SN95 FFR Approval 

Continued

 Step 2: Prepare documents and submit application to NIOSH, 

include final packaging

 Step 3: MOU defined FDA requirements evaluated by NIOSH, 

based on data provided

 Step 4: Evaluation and testing based on NIOSH requirements

 Step 5: SN95 approval issued, NIOSH CEL is updated

 Step 6: Manufacturer responsible for listing device with the FDA
NIOSH QUALITY ASSURANCE 

requirements - 42 CFR Part 84

 Quality Manual 

– Include the requirements outlined in NIOSH CA 2019-1019, and 42 CFR 84.

– The quality control plan is sufficient enough to determine that the respirator is safe. 

 Inspection Procedures

– Incoming inspection procedures are clearly defined and serve to verify that the materials received conform 

to the specifications that were ordered.

– Final inspection procedures are clearly defined and serve to verify that the fully assembled respirator 

conforms to the specifications on the drawing and the required performance specifications.

 PQPs/sampling plans – The definition of a lot or batch is clearly listed in the documentation. 

– The sampling plan used for each inspection is clearly stated. If a procedure other than those approved by 

NIOSH is used, the equivalency is explained (see September 24, 2012 Letter to Manufacturers for further 

clarifications). Table 1 below shows widely accepted equivalent plans. 
Exemptions from review under the MOU

 Respirators with exhalation valves or designs that are different than what the FDA 

has previously cleared (novel head suspensions)

 Specific disease and/or infection prevention

 Specific viral or bacterial filtration performance 

 Antimicrobial or antiviral functions

 Hypo allergenicity

 Filtration of surgical smoke or plumes 

 Nanotechnology

 Drug delivery systems

 Sterility claims

 Anything that isn’t an N95...Review the guidance and the MOU!
How will NIOSH-approved SN95s be labeled? 

 Surgical N95 respirator approval labels must include caution and 

limitation “S” defined as: Special or critical User Instructions and/or specific 

use limitations apply. Refer to User Instructions before donning.

 The User Instructions and packaging must state the following 

under the “S – Special or Critical User Instructions” heading: This 

respirator has been approved as a NIOSH N95 filtering facepiece respirator, 

for use in healthcare settings, as a Surgical N95 Respirator conforming to 

recognized standards for biocompatibility, flammability, and fluid resistance. 

 The approval label is no longer required to have the caution and 

limitation “P” – NIOSH does not evaluate respirators for use as surgical 

masks.
NIOSH is developing a Respiratory 

Protective Device Information Notice about 

Surgical N95s (SN95)

 The NIOSH-approved SN95 offers the same respiratory protection as a 

NIOSH-approved N95 filtering facepiece respirator (FFR). 

 Additionally, the SN95 conforms to FDA specified flammability, fluid 

resistance, and biocompatibility requirements and is intended for use in 

healthcare settings within, as well as outside, of the Operating Room. 

 A SN95 is therefore not limited to use during surgery, but is intended 

for use in all other healthcare settings where respiratory 

protection is needed to protect the wearer. 
Check these additional resources

The NIOSH Certified Equipment List (CEL)

NIOSH SN95 Trusted Resource Page

42 CFR Part 84

NIOSH Air-Purifying Standard Test Procedures

NIOSH Conformity Assessment Notices

NIOSH Respirator Approval Information

Disclaimer: 

Use of trade names and commercial 

sources is for identification only and 

does not imply endorsement by the 

Centers for Disease Control and 

Prevention or the U.S. Department of 

Health and Human Services.
Quality Partnerships Enhance Worker Safety and Health

Join NIOSH/NPPTL for Respiratory 

Protection Week, September 8-11, 2020 

and visit us at www.cdc.gov/niosh/npptl/

The findings and conclusions in this report are those of the authors and do not necessarily 

represent the official position of the National Institute for Occupational Safety and Health, Centers for 

Disease Control and Prevention. Mention of a company or product name does not constitute 

endorsement by NIOSH.
Question and Answers 

 NIOSH, FDA, and OSHA experts are standing by to answer your 

questions.

 Questions specific to an applicant will be identified for follow-up by 

NIOSH or the FDA, after the webinar.

Thank you for your time and attention today!
Resources

Slide Presentation, Transcript and Webinar Recording 

will be available at:

https://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and Subheading

Personal Protective Equipment (PPE)

Please complete a short survey about your FDA CDRH 

webinar experience. The survey can be found at 

www.fda.gov/CDRHWebinar

immediately following the conclusion of the live webinar.