Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28841 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0412] 

Revocation of Authorization of 

Emergency Use of an In Vitro 

Diagnostic Device for Detection and/or 

Diagnosis of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to BioFire Diagnostics, LLC for 

the BioFire Respiratory Panel 2.1 

(RP2.1). FDA revoked this Authorization 

on March 17, 2021, under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), in consideration of the De Novo 

classification order for the BioFire 

Respiratory Panel 2.1 (RP2.1) as a Class 

II (Special Controls) device under the 

generic name ‘‘Device to detect and 

identify nucleic acid targets in 

respiratory specimens from microbial 

agents that cause the SARS–CoV–2 

respiratory infection and other 

microbial agents when in a multi-target 

test.’’ The revocation, which includes an 

explanation of the reasons for 

revocation, is reprinted in this 

document. 

DATES: The Authorization is revoked as 

of March 17, 2021. 

ADDRESSES: Submit written requests for 

single copies of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On May 1, 

2020, FDA issued an EUA to BioFire 

Diagnostics, LLC for the BioFire 

Respiratory Panel 2.1 (RP2.1), subject to 

the terms of the Authorization. Notice of 

the issuance of the Authorization was 

published in the Federal Register on 

July 14, 2020 (85 FR 42407), as required 

by section 564(h)(1) of the FD&C Act. In 

response to requests from BioFire 

Diagnostics, LLC, the EUA was 

amended on December 22, 2020. 

II. EUA Criteria for Issuance No Longer 

Met 

Under section 564(g)(2) of the FD&C 

Act, the Secretary of Health and Human 

Services may revoke an EUA if, among 

other things, the criteria for issuance are 

no longer met. On March 17, 2021, FDA 

revoked the EUA for the BioFire 

Respiratory Panel 2.1 (RP2.1) because 

the criteria for issuance were no longer 

met. Under section 564(c)(3) of the 

FD&C Act, an EUA may be issued only 

if FDA concludes there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating the disease or condition. FDA 

issued a De Novo classification order for 

the BioFire Respiratory Panel 2.1 

(RP2.1) as a Class II (Special Controls) 

device under the generic name ‘‘Device 

to detect and identify nucleic acid 

targets in respiratory specimens from 

microbial agents that cause the SARS– 

CoV–2 respiratory infection and other 

microbial agents when in a multi-target 

test’’ on March 17, 2021, (https://

www.accessdata.fda.gov/cdrh_docs/ 

pdf20/DEN200031.pdf). FDA has 

concluded that this is an adequate, 

approved, and available alternative to 

BioFire Diagnostics, LLC’s BioFire 

Respiratory Panel 2.1 (RP2.1) EUA 

product for detection and/or diagnosis 

of the virus that causes COVID–19. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocation are available on the internet 

at https://www.regulations.gov/. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g) of the FD&C Act are met, 

FDA has revoked the EUA for the 

BioFire Respiratory Panel 2.1 (RP2.1). 

The revocation in its entirety follows 

and provides an explanation of the 

reasons for revocation, as required by 

section 564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 

28842 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 


EN28MY21.003</GPH>

U.S. FO,OD & DRUG 

,11,1:11i,i11N!sr~.M!blll 

!v.1:arch 17,2021 

Biofire Diagnostics, LLC 

Dt Kdstet1 Kanaek 

Senior Vice l'rcsidcut, Regulatory and Clinfoal Affairs 

515 Colorow Drive 

Salt Lake City, Utah 84108 

Re: DI,N:200031 

Trade1Device Name: BioFire Respiratory Panel 2.1 (RP2. l) 

Regulation N1.1mber: 21 CFR 866.3981 

Regullt.lion Name: Device to detect and identify nucleic acid targets in respiratory specimens from 

inicrobial agents that clit'lse the SARS-Co V-2 respiratory infectio1.1 and other 

microbial agents whim in a multi-target test. 

Regulatory Class: Cl!lSs IT 

Product Code:. QOF 

Dated: May 18, 2<J20 

RtlCeiVed: May 19, 2020 

Dear Dr: Kristen Kanack: 

1110 Center for Devices and Radiological Health (CDRH) of the Food.and Drug Administration (FDA) has 

1:lompleted its review of your De Novo request for classification of the Bit1Fire Respiratory Pnnel 2.1 

(RP2.l), a prescription device with the following indieatior1s.for use: 

The DioFire Respirnlmy Panel 2.1 (RP2. I) is a PCR-based .rmtltiplexed nucleic acid test i11tended for 

use v..ith the Bio Fil'e Fil mArrny 2.0 01' BioFire Fi hnArray Toreh systems for the simultaneous 

qualitative detection and identification of multiple respitatQry viral and bacterial nucleic acids in 

11asopharyngeal swabs (NFS) obtained from individuals s11spected of respiratory tract infectio11s1 

including .CO VID-19. 

The folio·wing organism types itnd subtypes are identified using the BioFire RP2. l: 

• Adenovirus, 

• Coronavirus 229E,. 

• Coro11avirus lIKUl, 

• Coromivirus NL63, 

• Cnronavirus OC43, . 

• Severe Acute Respirntory Syndrnme Corornwirus (SARS-C.;,)V-2), 

• Human Mctapncumovirus, 

• Huma11 Rhiuovirus/Enlerovirtm, 

U.S. Foo<! l'I Drug lidmioistrotiOll 

10903 N1ow. H;,mp,hireA,.,... Sliver Spiing, MO ZO!ill3 

~~ 
Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28843 


EN28MY21.004</GPH>

DEN20003 l -Kristen Kanack Page 2 

• fnfl\lenza A, itwluding s\ll;ltypes .ffl; Hl-2Q09;. and.H3, 

• Influenza B, 

• Para:inf1uenza Virus l, 

• Pataint)uenza Vit1:ts.2,, 

• Parainfhienza Vitus 3, 

• Pru-aitilluenza Virus 4, 

• Respitatory Syncytial Virus, • Bordetella parapertussis (IS] 001); 

• Bordetella pertussis (ptxP), 

• Chlamydia pnewnoniae, and 

• A1yc()plasrna pneumoniae 

Nucleic acids from the respiratory viral and bacterfalorganisms identit1ed bythis test are generally 

detectable in NPS specimens. during the acute phase of infection. The detection and identification.of 

specific viral and bacterial nucleic acid..q from i11dividuals exhibiting signs and/pr symptoms of 

respiratory infecti<lrtJs indicative ofthe presence ofth:e ide11tified 1nicr®rga11ism and aids in the 

diag1wsis ofrespiratory infection:ifused inconj1mction with other clinical.and epidemiological 

information. The results ofthis lest should not.be used as the sole basis for diagnosis, treatment, or 

other patient management decisions. 

'.Negative .results in the setting ()fa respirittory ilh1ess n1ay be due to infection with pathogens thatare 

not detected by this test, or lower respiratory tract infe.ction thatmaynot be detected by an NPS 

specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by 

the. Bio Fire RP2. l may not be the definite cause· of disease .. Additional laboratory testing (e;g; 

bacterial and viral.culture, immunofluorescence, and r-adiography}may be necessary when evaluating 

a patient with possible respiratory tractinfection. 

Although this letter ref~ to Y<!urproduct l!S a device, please be awltre thatsome granted products may 

instead be combination products. If you bave questions on whether your product is a combinationproduct, 

contact CDRHPtoductJurisdictfon@toa.h:h:s.gov. FDAconchldes .that this device should be classified into 

Class IL 'Ibis order; therefore, classifies the Bio Fire. Respiratory Panel 2.1 (RP2.l), and substantially 

equivalen.t devices o(th:is :generic type, into ClassJlun.der the generic name Pevicetl> detect and identify 

nucleic acldtargets in respiratQry.specitnens from micwbial agents that cause the :SARSsCoV-2; respiratory 

infection and other microbial agents when in a multi-target test. 

FDAidentifies this generic type ()f device as: 

Device to detect and identify nucleic acid.targets in respiratory specimens from .microbial agents that 

cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-targettest. A 

device to detect and ide11tify nucleic add. targets in respiratory specimen~ fto111 microbial agents that cause 

the SARS-Co V-2 respiratory infection and .. other microbial agents when in a 11:1.ulti-target test is an in vitro 

dia:g11ostic dev:ice intended for the detection and identification ofSARS-Co V~2 and other microbial aients 

when in a multi•targettest in human. clinical respiratory specin1ens from patients suspected ofrespiratory 

infection who are at risk.for exposure. or who may have been. exposed to these agents, The device is intei1ded 

to aid in the.diagnosis oftespiratoryintection i11.conjunction with other clinical, epidemioll>gic, and 

laboratory data or other risk factors. 
28844 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 


EN28MY21.005</GPH>

Page 3 

•ofthe Food,,~•and·Cosmetic,Act{theFD&C·Ac~}was,1Ullel1dedbt~·:iio7.•otthe 

.. . .. . .... .. . . ... . .......... •··· .· ........ ··· Sllf~W:AA<!Jnn(i.yationi\~ (FD~) !lllJuit~t2tfl2, ~'la~J1i:o~~ optronsforTu:,. mro classifu:ation .. Fir$t,. allY'~"1nO~ivesa l'not.~stmilitilly~~t" {NSE} 

detem'lhiatioom~toa·5l~)·fota·.devirethath«snot·beeiiprevm~dassified:imdettheAct:li:lay 

~estFDA •. tollllik:ei:1~~edchuisttlC1:1tio:11ofthedeviceimd.er··secttt,n••~lJ(a}(l)pfthe.Act; On ..... ... . 

Decemb¢r13;20lfi;•the21st•Centm:yeutesAfitmnoveda~ent•tbataneNow•r~be submitted 

~~~.day~of~~iving•~~•de~~~.·J\l~tiv~ty~ any~·~de~~tlliet'eJsllQ l~gidltmatketeddevice¥ti:Wmcli.tobueadeterminafionof~tial$vtileiICemar~~to 

~~~~~~~iμ1.:~onof... · · of.ffleA-ct~Q1),t~t~@i&~ 51:0(k),FDAshall;withm:12 · . ede:vice. Thi$classilkationshall 

~.~mitiiil.~I~cauonoftliti ·.······.·. ce\ < . . ys iifieftlie~~<>fan.m&r~sifymgJhifdevree:, ·wAlllU$tptibli$hJutotice•mtheF~Regi$fer'iltlll01JnCing.thecl~cation, 

~.~.··t!t.2i52:<i~·.1:ID'A,.i;ecei~~:pe;.ll(<>:vo~i~sliiclifi9n<>ttheBiqf'~i+toiy~llI 

2,l•(RP2;1l.Tlietequestwas~:undersectitlli513.(ij(2)•oftheFD&CA't:t•\hi,·orttertoc~ifyihe 

J3iqI/ire~espira~Plwel•·~,l (RPA;lJ111t<>cfa;sd~.•ll:,it~n!;\CeSSaJ'Yfh,aitliepropo~•·c,IMs·.~Yesutl.ic:ient •~t~··cootr-0l'sto•J.)l'Qvide®asona'bre.assuraiiCe.o!the·•siue,aildeffuctivenessofihedevice•futits 

ilit~diidμse, Aftei: .• ~yiey,•of~••mfonnatiOll~fui(t~mtlie•Pe·•~ovo:i:e~t,•f'I)i\:Iillsd~Jhaf, 

fotthe~vio~·•~ta~'ilidkaijtttiSfotllSe,tlie,Iw!~.Respiratoi:rJ~anel2:i.~J?~•~e~itt, 

~.•:rI~th~~bli~nlof~~{)~for1.1l~l(IL ..• mAli¢li~v~~•~111ss .•• ll(~~)•cOnj:rO~' provideteasonabreassutance·of'the~$ldcll'ecttveness◊fllie~vi¢e~;.Th:eidehtilied~and 

·wff.gation~•~iate4¥!ith•tli~devicetypeateJ~in:ffiefolfo~gtable: · 

·.Risk:Of1lllinacctJrate ~. result{fiilse.pQSitive·.orfalse 

negativetesfilt)·.~.t<> 

imprtlper f?:llll(mf 

lllimagemeiit 

Mi~~~tation.oftest 

tesillts: leadingto 

mi~dmg11o~isarnl~iat~ 

•mk•off!US(ftest:re!llllw 

C:ertainlallelinginf~n,mcltt(iinglimitatiollll; V(fil1linW!, 

de'Vicedescriptions:;.eKPlanationofpt~utes;.and;perf()mlaJlCe 

fufoimationideiltified.fu .. special eontrols:(1);(3),·(5}fand•.(6?. 

I.Jseof~ertain~ncollection()evices•identified,iilspecial 

eonttol (2): 

Certainde•·•verificaffun·andvalidation,.docutnentatiotlof 

certafu·i!iiafytical.•sti.'tdiesfflld.·dlliiitllil smdies;ri\ik··~ 

.~tegi~,•.andde'lieedesctjptioiiSi<\entifierl,.in~iil .. control 

(4); 

Teslliigof~teriied\iifal•sarilpl~andm'belliig•·~tiott 

i'dennfieu m !rtleeiaI contrott11. 

C:ertain4'beling ~on, iilclμqing fu,nitations, ~~' device de-lions:,. e,q>lanation ofpt~~ 

Jntetpiti:n~tionfufoimation, lliidpetf'dm:iatic~•informauon identiJiediililJ)!:lcial~Is·(ll,.(3,),·wd(a): 

certam. de• yerificmirin.andvalidaliQit; •. di:i.:umentation of certaintmat~ s~s and JiinR:ai sirulies,risk~ strategies,•.and··device•descriptfons:ideiilified.fuSpecial•control 

(4)~ 
Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28845 


EN28MY21.006</GPH>

:DEN200031--•,-.Ktisten••~-

•t:anyoyet1crossoontiiminatimi;:iipecimeii•:smbinty,:preciswri;;~bilify,ami-01mica1_ ·- · 

---(iii)·•- ;=r::adescrlptlons:otille•testj)tooelliite(s); -the.mteiptetalion•<>fteilftesuititfot~tfuica1-
28846 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 


EN28MY21.007</GPH>

DEN200031 - Kristen Kanack Page 5 

(B) 'The test results should be interpreted in conjunction with other clinical and laboraiory 

data available to the clinician; 

(C) 1bere is a. risk of incorrect results due to the pres.:nce of nucleic acid sequence variants in 

the targeted pathogens; 

(D) That positive and negative predictive values ru:e highly dependent on prevalence; 

(E) Accurate results are dependent on adequate specimen collection, transport, storage, ru1d 

processing. Failure to observe proper procedures in any one of these steps can lead to 

incorrect results; md 

(F) When applicable ( e.g., recommended by the Centers for Disease Control and Prevention, 

by current well-accepted clinical guidelines, or by published peer-reviewed literature), that 

the clinical performance may be affected by testing a specific clinical subpopulation or for 

a specific claimed specimen type. 

4, Design verification and validation must include: 

(i) Detailed documentation, including perfonuance results; from a clinical stmiy that includes 

prospective (sequential) samples for each claimed specimen type and, as appropriate, 

additional characterized clinical samples. The clinical study must be performed on a study 

population consistent with the it1te11ded use population and compare the device. perfom1ance 

to results obtained using a comparator that FDA has determined is appropriate. Detailed 

documentation must include the clinical study protocol (including a predefined statistical 

analysis plan), study report, testing results, ru1d results of all statistical analyses. 

(ii) Risk analysis and documentation demonstrating how risk control measures are implemented 

to address device system hazards, such as.Failure Modes Effects Analysis and/or Hazard 

Analysis. This documentation must include a detailed description of a protocol (including all 

prncedures and methods) for the continuous monitoring, ide1rtification, and handling of 

genetic mutations and/or novel respiratory pathogen isolates or strains (e.g,, regular review of 

published litetature Md periodic in silioo analysis of target sequences to detect possible 

mismatches). All results of this protocol, including any findings, must be documented and 

must include any additional data analysis that is requested by FDA in response to a11y 

performance concerns identified underthis section or identifi.ed by FDA during routine 

evaluation. Additionally, ifrequested by FDA, these evaluations must be submitted to FDA 

for FDA review within 48 hours of the request. Results that are reasonably interpreted to 

support the conclusion that novel respiratory pathogen strains or isolates impact the stated 

expected performance of the device must be sent to FDA immediately. 

(iii) A detailed description of the identity, phylogenetic relationship, and other recognized 

characterization of the respiratory pathogen(s) that the device is designed to detect. In 

addition, detailed documentation describing h<)W to interpret the device results and other 

measures that might be needed for a laboratory diagnosis of respiratory infection. 

(iv) A detailed device description, including device components, ancillary reagents required but 

not provided, and a detailed explanation of the methodology, including molecular target(s) for 

each analyte, desigtt of target detection reagents, rationale for target selection, lhnitfog factors 

,if the device (e.g., saturation level of hybridization and maximum amplification and detection 

cycle number, etc.), internal and e>-.1ernal controls, and computational path from collected raw 

data to reported result ( e.g., how collected raw signals are converted into a reported signal and 

result), as applicable. 
Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28847 


EN28MY21.008</GPH>

DEN20003 l - Kristen Kanack 6 

(v) A detailed description of device softwarn, including software applications and hardware-based 

devices that incorporate software. 111e detailed description.must include documentation of 

verification, validation, and hazard analysis and risk assessment activiti<1s, including an 

assessment of the impact of threats and vulnerabilities on device functionality and end 

users/patients as part of cybersecurity review. 

(vi) For devices intendedfor the detection and identification of microbial agents for which an 

FDA recommended reference panel is available, design verification and validation m1ist 

include the perfonnance results of an analytical study testing the FDA recommended 

reference panel of characterized samples. Detailed documentation must be kept of that study 

and its results, including the study protocol, study report for the proposed intended use, testing 

results, and results of all statistical analyses. 

(Vii) For devices with an intended use that includes detection of Inf1uenza A and Influenza B 

viruses and/ot detection and differentiation between the Influenza A virus subtypes in human 

clinical specimens, the design verification and validation must include a detailed description 

of the identity, phylogenetic relationship, or other recognized characterization of the Influenza 

A and B viruses that the device is designed to detect, a description of how the device rnsults 

might be used in a diagnostic algorithm and other measures that might be needed for a 

laboratory identification of Influenza A or B virus and of specific Influenza A vims subtypes, 

and a description of the clinical and epidemiological parameters that are relevant to a patient 

case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation 

of the device compared to a currently appropriate and FDA accepted comparator method. 

Detailetl documentation must be kept of that study and its results, including the study 

protocol, study report for the proposed intended use, testi11g results, and results of all 

statistical analyses. 

5. When applicable, petformance results of the analytical study testing the FDA recommended reference 

panel described in paragraph (b)(4)(Vi) of this section must be included in the device's labeling under 

21 CFR 809.l0(b). 

6. For devices with an intended use that includes. detection ofinfluenza•A and Influenza B viruses 

and/or detection and differentiation between the Influenza A virus subtypes in human clinical 

specimens in addition to detection of SARS-Co V-2 and similar microbial agents, the required 

labeling under 21 CFR 809.lO(b) mnst include the following: 

(i) Where applicable, a limiting statement that petformance characteristics for Influenza A were. 

establishedwhen Influenza A/H3 and A/Hl-2009 (or other pertinent Influenza A subtypes) 

were the predominant Influenza A viruses in circulation. 

(ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is 

suspected based on current clinical and epidemiological screening criteria recommended by 

public health authorities, specimens should be collected with appropriate infection control 

precautions for novel vimlent influenza viruses and sent to state or local health departments 

for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is 

available to receive and culture specimens. 

(iii) Where the device results interpretation involves combining the outputs of several targets to 

get the final results, such as a device that both detects Influenza A and differentiates all 

!mown Influenza A subtypes that are currently circulating, the device's labeling must include 

a dear interpretation instruction for all valid and invalid output combinations, and 

reconunendations for any required follow· up actions or retesting in the case of an unusual or 

unexpected device result. 
28848 Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 


EN28MY21.009</GPH>

DEN200031 • Kristen Kanack Page 7 

(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces 

negative test results for all specific influenza A subtypes intended to be differentiated (i.e., 

Hl-2009 ai14 II$); this result requires notification of appropriate local, state, orfederal public 

health authorities to detem1ine necessary me.asures for vedfication and to further detennine 

whether the specin1en represe1its a novel strain oflnflue!1Zll A 

7. If one of the actions listed at section 564(b )(l)(A)~(D) ofthe Federal.Food, Drug, and Cosmetic Act 

occuts with respect to art influenza vira:I stta:.in, .or ifthe Secretary of Health and. Human.Services 

(IlHS) dete1mines, under section 319(a) ofthe Public Health Service Act, that a disease or disorder 

present~ a public health emergency, or that & public health emergency otherwise exists; with respeqt 

to an influenza vital strain: 

(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples 

are available for test evaluation, the mrumfacturer must.have testing performed on.the device 

with those influenza viral samples in. accordance with a standai'.dized protocoLconsidered lUld 

detenninedby FPA to be accept&ble and appropriate, 

(ii). Within 60 days from the date that FDAnotifies manufacturers that characterized.influenza 

viral silitlples are available fortest evaluation and.continuing until 3 years from that date, the 

results of the. i11f1uertza emergency analytical reactivity testing, i1wlu:ding the detailed 

information for the virus tested as described in the aertificate of'authentfoation, must be 

included as part of the device's labeling ina tabular fonnat, either by: 

(A) Placing the results directly in the device's labeling required tmder 21 CFR 809 .. lO(bJ that 

accofupllllies the device in a separate section of the labeling where analytical reactivity 

testing.data can be found, but separate from the annual anatyticalreacti:vity testing results; 

or 

(B)In a section of the device's label or in other labeling that accompanies the device, 

prominently providing a hyperlinkto the manufacturer's public website where-the 

ana:Iytica:l reactivity testing data: .. can be found, Tue manufacturer's website, as weli as the 

primary part of the manufacturer 'swebsite that discussei'lc the device, must provide a 

prominently plac;ed hyperHnk to the website containing tliis. information and mustallow 

unrestricted. viewing a.ccess. 

Section 51 O(m) ofthe FD&C Act provides that FDA may exempta class II device from the premarket 

notification requirements under se"1:ion 510(k) of.the FD&C.Act, if FDAdetennines that premarket 

notificationis notnecessary to provide teasonabkassurance of tful,sa:fety-lUld effectiveness ofthe. de.vice 

type. FDA has determined premarkeinotifi:cation ii, necessary to provide reasonable assurlUlce of the safety 

and effe.::tiveness of the device type and, therefor~, the Mvi.::e is nQt exemptfron1 the premar){etnotification 

requirements of the FD&C A1.,1:. Tiius; persons who intend to market this device type must stibmita 

premarket notification. containihg infomiation.on the device to detect and identify nucleic acid targets in 

respiratory specin1eits from microbialageiits that cause the SARS-CoV-2 respiratory infection and other 

microbial agents whenin a multi-target test they intend to market prior to marketing the device, 

Plea.'le.be advised that FDA's decision to grru1t this De Novo.request does not mean that FDA has made a 

determination thatyour device complies with. other requirements ofthe FD&C Act or.any Federal statutes 

and regulations ad:ntlnistered by other Federal agencies. You.must comply with :allthe FD&C Act's 

requireme11t~, including; but notlimited to:reglstrationand listing (t1 CFR Part S07); labeling ~21 GfR 

Parts 801 ru1d 809);medical device reporting (reporting of medical device-related adverse events) (21 CFR 

803) for devices orpostmarketingsafety reporting (21 CFR4,. Subpart B) for combinationproducts (see 
Federal Register / Vol. 86, No. 102 / Friday, May 28, 2021 / Notices 28849 

Dated: May 24, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11385 Filed 5–27–21; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0455] 

Revocation of Authorization of 

Emergency Use of a Medical Device 

During COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to Battelle Memorial Institute for 

the Battelle Critical Care 

Decontamination System. FDA revoked 

the Authorization on April 30, 2021, 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) as requested 

by Battelle Memorial Institute on April 

2, 2021. The revocation, which includes 

an explanation of the reasons for the 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the 

Battelle Critical Care Decontamination 

System is revoked as of April 30, 2021. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a Fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On March 

28, 2020, FDA issued the Authorization 

to Battelle Memorial Institute for the 

Battelle Critical Care Decontamination 

System. Notice of the issuance of the 

Authorization was published in the 

Federal Register on June 5, 2020 (85 FR 

34638), as required by section 564(h)(1) 

of the FD&C Act. The authorization of 

a device for emergency use under 

section 564 of the FD&C Act may, 

pursuant to section 564(g)(2) of the 

FD&C Act, be revoked when the criteria 

under section 564(c) of the FD&C Act for 

issuance of such authorization are no 


EN28MY21.010</GPH>

DEN20003J - Kristen Kanack Page .8 

bttps://w-wwJaa,gov/combittation-productsfguidance-regulatory-infonnation/postmarketinll:-safety-rep-Ortmgcombination-productskgood manufacfuring praetk.e requirements as set forth in the qualify systems (QS) 

.regulation (21 CPR.Part 820) funlevices oi-currenf good manufacturing practices (21 CFR4, SubpartA)foi: 

combination products; and if applicable, the electronic product radiation control provisions (Sections 531-

542 of1he FD&C Act); 21 CFR louiF 1050. . . 

A notice announcing ihis classil'ication order will be published m1:he Federal Register. A copy of this order 

and supporting docinnentation are on file in the Dockets Management Branch (HFA-305), Food and Drug 

Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection 

between 9 a.:m, and4 p.m., Monday through Friday. 

As a result of1his order, you may innllediately market your device as. described in the De.Novo request 

subject to the geneml: control provisions of 1he FD&C Act and the special controls identified in ihis order: 

For comprehensive regu}afoiy infmmation about medical devices and radiation-emitting products, please see 

·Device.Advice {hqps:/fwww.fda.govfmedical.a.devic.es/device-advic.e-comprehensive-regularory-assiirtance) 

and CDRH Learn (https:/lw-ww.fda.govlttajmng-and-continuing-education/cdrh-leam). Additionally, you 

may contact.the Division of Industry and Consumer Education (DICE)toask a question about a specific 

regulatory topic. See 1he DICE website (hltps://www..fda.gov1medical~deviceyde\.'lrecadvice-commehensiveregulatory-assistanee/contact-ns-division-,industry-and-consumer-education-dice)·for more information or 

contactDICEbyemail (DIC£'lilfda.hhs.gov)orpbone(HW1Hi38-:2041 ot 30M96-7100). 

Jf you have anyqnestionsconceming the contents of the. letter; please contact Ricky Soong at 301-348-i894. 

Sincerely,. 

Uwe Scherf, M;Sc,, PhD. 

Director 

Division ofMiciobiology Devices 

OHTT: Officeofin Vitro Diagnostics 

and Radiological Hea11h 

Office of Product.Evaluation and Quality 

Centet for Devices and Radiological IIealth