NIOSH Conformity Assessment Letter  
   to Manufacturers  
NIOSH CA 2020-1031 
              August 2020 
 
 
 
     
             
Subject: Effective Immediately - In response to COVID -19 – UPDATED NIOSH 
prioritization for accepting and examining  particulate filtering respirator 
approval applications, including Surgical N95 respirators,  submitted by 
existing approval holders , new domestic manufacturers/applicants , and new 
international manufacturers/applicants  
Su
persedes NIOSH CA 2020- 1027  Document Number  
NIOSH CA 2020-1031 Page 2 of 3 
I
n response to the nation ’s effort to control the spread of  coronavirus disease 2019 (COVID -19), the 
National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program is 
accepting and prioritizing applications received for new approvals and extension of approvals  
submitted by existing approv al holders and new domestic respirator manufacturers /applicants .   
N
IOSH is committed to protecting healthcare personnel  and Americans preparing to return to work 
by accepting and expediting applications to increase the supply of NIOSH -approved particulate 
filtering (air -purifying) respirators  and ensure quality products providing  the intended protections are 
available . The applications accepted can include those seeking or modifying approval for filtering 
facepiece respirators  (FFR s), including Surgical N95 FFRs described in  NIOSH CA 2018 -1010R1 , half 
mask and full facepiece air- purifying respirators (APR s), and powered air -purifying respirators 
(PAPR s). During the COVID -19 response  period , NIOSH is not accepting applications for approval of 
FFRs with novel head suspensions, e.g. , ear loops. NIOSH is focusing its resources to approve designs 
with traditional two head -strap suspensions , commonly used in respirator designs  demonstrating the  
fit and protection required by OSHA.  
NIOSH has posted updated guidance (“SN95 Guidance”, NIOSH CA 2018 -1010R1 ) for 
manufacturers/approval holders interested in applying for Surgical N95 FFR approval under the consolidated NIOSH and FDA MOU. Applicants  MUST follow th e guidance and shou ld expect approval 
timelines based on this notice.  
E
ffective immediately and including applications accepted by NIOSH prior to publication of this 
notic e, NIOSH will prioritize applications in the order described below: 
1)D
omestic approval holders submitting a new or an extension application, including a new or
extension  application using the SN95 G uidance . NOTE: This does NOT  include claims about
barrier performance based on ASTM 2100- 19, Standard Specification for Performance of
Materials Used in Medical Masks, or claims exceeding the threshold limitations defined in the
NIOSH/FDA MOU .
2)D
omestic and i nternational approval holders submitting Quality Assurance (QA) applications
to facilitate FFR, APR, and PAPR production at additional manufacturing sites, in accordancewith established and NIOSH -approved QA systems.Subject:  Effective Immediately  - In response to COVID -19 – UPDATED NIOSH 
prioritization for accepting and examining  particulate filtering r espirator approval 
applications, including Surgical N95 respirators,  submitted by existing  approval 
holders , new domestic manufacturers/applicants, and new international 
manufacturers/applicants  
Su
persedes NIOSH CA 2020- 1027  Document Number  
NIOSH CA 2020-1031 Page 3 of 3 
3)N
ew domestic applicants : NIOSH has develop ed procedures to conduct virtual domestic site
qualification evaluations of new domestic manufacturing and quality management facilities,
for applicants seeking their first N IOSH approval for an FFR, APR , or PAPR.  Alternatively,
NIOSH may use a contractor to conduct the site qualification visit.
4)I
nternational approval holders submitting a new application using the SN95 G uidance . NOTE:
This does NOT  include claims about barrier performance based on ASTM 2100 -19, Standard
Specification for Performance of Materials Used in Medical Masks, or claims exceeding thethreshold limitat ions defined in the 
NIOSH/FDA MOU .
5)I
nternational approval holders submitting a new or extension application.
6)N
ew international applicants submitting a new application  using the SN95  Guidance, with
priority given to products manufactured in Canada and Mexico. Timelines will depend on theability to arrange and complete initial site qualification visits.  NOTE: This does NOT  include
claims about barrier performance based on ASTM 2100- 19,
 Standard Specification for
Performance of Materials Used in Medical Masks, or claims exceeding the thresholdlimitations defined in the 
NIOSH/FDA MOU .
7)N
ew international applicants, with priority given to  products manufactured in  Canada and
Mexico . Timelines will depend on the ability to arrange and complete initial site qualification
visits.
8)N
ew international applicants re -submitting a new application after a prior denial was issued
by NIOSH. Timelines will depend on the ability to arrange and complete initial site
qualification visits.
On
ce NIOS H approved, the respirators will be added to the NI OSH Certified Equipment List and will 
thus be covered under the FDA’s clarification letter and Emergency Use Authorization  (EUA), dated 
March 28, 2020  for use by healthcare personnel.  
T
he prioritization listed above will further impact NIOSH ’s ability to process requests received from  
new international respirator manufacturers for manufacturers’ codes  and to answer their questions 
related  to the Approval Program. Additionally, due to ongoing, heightened concerns over 
counterfeiting , NIOSH will not  respond to emails that lack recognizable company domains.  Examples 
include emails that look like 3894876@hotnet.net, cv2009@vip.126.com, or  3273865@qq.com.    
NIOSH will only respond to i nquiries for approval received from a n email address recognizably 
asso ciated with a  legitimate business  or stakeholder.