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AIRAC date State City Airport FDC No. FDC date Subject 

16–Jun–22 ..... OR Redmond ........... Roberts Fld ........................................... 2/8524 4/25/22 ILS OR LOC RWY 23, Amdt 5. 

16–Jun–22 ..... OR Redmond ........... Roberts Fld ........................................... 2/8525 4/25/22 RNAV (GPS) Z RWY 29, Amdt 1A. 

16–Jun–22 ..... TX Austin ................. Austin Exec .......................................... 2/8614 4/15/22 RNAV (GPS) RWY 13, Orig-A. 

16–Jun–22 ..... ID Grangeville ......... Idaho County ........................................ 2/8625 4/25/22 RNAV (GPS) RWY 26, Orig. 

16–Jun–22 ..... TX Beaumont ........... Beaumont Muni .................................... 2/8948 4/18/22 RNAV (GPS) RWY 13, Amdt 1. 

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[FR Doc. 2022–10443 Filed 5–13–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2019–N–5192] 

Microbiology Devices; Reclassification 

of Human Immunodeficiency Virus 

Serological Diagnostic and 

Supplemental Tests and Human 

Immunodeficiency Virus Nucleic Acid 

Diagnostic and Supplemental Tests 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is issuing a final order to 

reclassify certain human 

immunodeficiency virus (HIV) 

serological diagnostic and supplemental 

tests and HIV nucleic acid (NAT) 

diagnostic and supplemental tests, 

postamendments class III devices with 

the product code MZF, into class II 

(special controls), subject to premarket 

notification. Through this final order, 

FDA is also adding two new device 

classification regulations and 

identifying special controls that the 

Agency believes are necessary to 

provide a reasonable assurance of safety 

and effectiveness for these device types. 

This final order will reduce the 

regulatory burdens associated with 

these device types, as manufacturers 

will no longer be required to submit a 

premarket approval application (PMA) 

but can instead submit a premarket 

notification (510(k)) and receive 

clearance before marketing their device. 

DATES: This order is effective June 15, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, Center for Biologics 

Evaluation and Review, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended, establishes 

a comprehensive system for the 

regulation of medical devices intended 

for human use. Section 513 of the FD&C 

Act (21 U.S.C. 360c) established three 

categories (classes) of devices, reflecting 

the regulatory controls needed to 

provide reasonable assurance of their 

safety and effectiveness. The three 

categories of devices are class I (general 

controls), class II (general controls and 

special controls), and class III (general 

controls and premarket approval). 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f)(1) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval, unless and 

until, (1) FDA reclassifies the device 

into class I or class II, or (2) FDA issues 

an order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. FDA determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act and part 807 (21 CFR part 

807), subpart E, of the regulations. 

A postamendments device that has 

been initially classified in class III 

under section 513(f)(1) of the FD&C Act 

may be reclassified into class I or II 

under section 513(f)(3) of the FD&C Act. 

Section 513(f)(3) of the FD&C Act 

provides that FDA, acting by 

administrative order, can reclassify the 

device into class I or class II on its own 

initiative, or in response to a petition 

from the manufacturer or importer of 

the device. To change the classification 

of the device, the proposed new class 

must have sufficient regulatory controls 

to provide a reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

On February 21, 2020, FDA published 

in the Federal Register a proposed order 

(85 FR 10110) to reclassify certain HIV 

serological diagnostic and supplemental 

tests and HIV NAT diagnostic and 

supplemental tests from class III to class 

II (special controls), subject to 

premarket notification. The comment 

period on the proposed order closed on 

April 21, 2020. 

II. Comments on the Proposed Order 

In response to the February 21, 2020, 

proposed order, FDA received several 

comments from public health 

organizations, device manufacturers, 

and individuals by the close of the 

comment period, each containing one or 

more comments on one or more issues. 

We describe and respond to the 

comments in this section of the 

document. The order of response to the 

comments is purely for organizational 

purposes and does not signify the 

comment’s value or importance nor the 

order in which the comments were 

received. 

(Comment 1) Nearly all comments 

expressed general support for the 

proposed reclassification along with 

appropriate controls to assure safety and 

efficacy. The comments noted that 

reclassification could improve access to 

HIV testing, support earlier diagnosis 

and facilitate prevention of HIV, 

enhance laboratory efficiency and 

patient management, and strengthen 

public health surveillance. 

(Response 1) We acknowledge and 

appreciate the supportive comments. 

We are reclassifying these devices and 

establishing the special controls 

published in the proposed order with 

some clarifications and modifications, 

as summarized in section III. 

(Comment 2) Several comments 

recommended the reclassification of 

HIV viral load monitoring tests, which 

were not included within the scope of 

the proposed order. The comments 

expressed differing opinions regarding 

whether HIV viral load reclassification 

should be included in this final order. 

One comment also noted that, at the 

119th meeting of the Blood Products 

Advisory Committee (BPAC) held on 

July 19, 2018 (the Panel), there was clear 

support from the committee for 

reclassification of HIV viral load 

monitoring tests. 

(Response 2) We appreciate the 

comments and note that FDA published 


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a proposed order to reclassify HIV viral 

load monitoring tests from class III into 

class II on November 24, 2021 (86 FR 

66982). HIV viral load monitoring tests 

have different intended uses than HIV 

serological and NAT diagnostic tests 

and raise different issues of safety and 

effectiveness. We do not think it is 

appropriate to reclassify HIV viral load 

monitoring tests in this final order 

without providing the public with the 

opportunity to comment on the basis of 

the proposed reclassification or on the 

special controls. Thus, we are 

proceeding with finalizing 

reclassification of HIV serological and 

NAT diagnostic and supplemental tests 

and are separately pursuing 

reclassification of HIV viral load tests. 

(Comment 3) One comment 

recommended reclassification of homeuse HIV diagnostic devices and stated 

that reclassification of such tests from 

class III to class II would encourage 

manufacturers to develop new tests for 

home use, which could help address 

current gaps and barriers to testing in 

certain populations. However, another 

comment did not support 

reclassification of HIV tests intended for 

home use. 

(Response 3) FDA has approved only 

one home-use HIV diagnostic test to 

date, which is indicated as an in vitro 

diagnostic home-use test for detecting 

HIV (HIV–1 and HIV–2) in oral fluid. A 

positive result is preliminary and 

followup confirmatory testing is needed. 

As noted by one of the comments, 

home-use HIV diagnostic tests were not 

within the scope of the proposed order, 

and there are distinct performance 

considerations and risks associated with 

home-use HIV diagnostic tests. Thus, 

FDA does not intend to reclassify homeuse HIV diagnostic tests at this time, 

and such devices are not included in the 

scope of this final order. 

(Comment 4) Several comments, 

while generally expressing support for 

the proposed reclassification of HIV 

serological and NAT diagnostic and 

supplemental tests from class III to class 

II, expressed concerns regarding the 

proposed special controls on clinical 

sensitivity and specificity: 

• Performance of Currently Approved 

HIV Diagnostic Tests: The comments 

stated that currently approved tests may 

not perform at the level specified in the 

special controls. One comment said that 

‘‘none of the currently approved assays 

perform at the level specified by the 

special controls.’’ Another comment 

said that during the July 19, 2018, Panel 

meeting, it was noted that ‘‘many of the 

currently approved assays don’t actually 

perform at these levels.’’ 

• Performance Levels— 

Harmonization with Hepatitis C Virus 

(HCV) Tests: Several comments 

expressed concerns about the proposed 

sensitivity and specificity levels for HIV 

tests being too stringent in general and 

not harmonized with those proposed for 

HCV tests. Others suggested that the 

proposed performance levels for 

sensitivity and specificity were 

inconsistent with the discussion at the 

July 19, 2018, Panel meeting. One of 

these comments recommended that the 

performance measure level of stringency 

should be a point estimate of 99 percent 

with a 95 percent lower bound of the 95 

percent confidence interval and noted 

that the proposed special controls 

currently require a lower bound of the 

95 percent confidence interval greater 

than or equal to 99 percent. 

• Characterization of Performance 

Measures—Harmonization with HCV 

Tests: One comment indicated that, in 

order to harmonize HCV test 

requirements and HIV serologic and 

nucleic acid test requirements, the HIV 

test performance measures should be 

characterized as Positive Percent 

Agreement and Negative Percent 

Agreement with a predicate assay, 

rather than clinical sensitivity and 

specificity (i.e., comparing the 

performance of antibody tests with other 

antibody tests, rather than with the 

presence or absence of disease). 

• Sample Size: Two comments noted 

the investment needed to conduct 

clinical trials with sufficiently large 

sample size to demonstrate the required 

levels of sensitivity and specificity will 

serve as a disincentive for 

manufacturers to develop new assays or 

to adapt existing assays and will 

ultimately not meet the reclassification 

goal of improving access to quality HIV 

testing. The comments noted that 

sensitivity and specificity requirements, 

with related sample size needs, are one 

of the main driving forces of clinical 

trial cost. 

(Response 4) We disagree with the 

comments regarding the performance of 

currently approved diagnostic tests, 

harmonization with HCV performance 

levels, and clinical trial sample size. 

FDA’s experience with HIV diagnostic 

and supplemental tests demonstrates 

that the proposed criteria are consistent 

with the performance demonstrated by 

currently approved tests, which have a 

long history of safe and effective use. 

There may be, under some 

circumstances, differences observed in 

the performance of a test when used in 

a real-world setting and its performance 

in the more controlled environment of 

a clinical study. However, FDA believes 

that lowering the criteria for clinical 

study performance raises the risk that 

future devices will not provide the same 

level of safety and effectiveness as 

currently approved devices and, thus, 

will not provide a reasonable assurance 

of safety and effectiveness. The 

comments indicating that ‘‘none of the 

currently approved assays perform at 

the level specified by the special 

controls’’ and that ‘‘many of the 

currently approved assays don’t actually 

perform at these levels’’ are inaccurate; 

all currently approved HIV diagnostic 

tests met or exceeded FDA’s proposed 

criteria in the primary clinical studies 

submitted for approval. 

FDA does not consider the sensitivity 

or specificity of tests meeting a 95 

percent lower bound confidence 

interval of 95 percent to be equivalent 

to the sensitivity or specificity of tests 

meeting a lower bound of 99 percent. 

Tests that are unable to meet FDA’s 

criteria in the special controls could 

potentially generate a much higher 

number of incorrect results than tests 

that meet FDA’s proposed criteria. This 

risk is present with the lower bound of 

95 percent even if the point estimate is 

constrained to 99 percent. Thus, 

introduction into the market of new HIV 

tests with decreased performance 

compared with currently available tests 

may result in a large increase in the 

number individuals who would receive 

incorrect results. Incorrect test results, 

both false positive and false negative 

results, endanger both individual and 

public health because people may 

undergo unneeded treatment or may be 

denied needed treatment and may 

inadvertently spread HIV. 

Regarding aligning the proposed 

performance criteria with the 

performance criteria proposed as special 

controls for certain HCV antibody tests 

and nucleic acid-based HCV ribonucleic 

acid (RNA) tests, the performance 

necessary to provide a reasonable 

assurance of safety and effectiveness of 

an in vitro diagnostic device is based 

on, among other things, the specific 

analyte measured, the disease or 

condition for which the particular 

device is intended to be used in 

diagnosis, and the conditions of use. 

This means that the performance criteria 

identified in special controls may vary 

between devices that measure different 

analytes (e.g., HIV and HCV) or with 

different conditions of use (e.g., point of 

care (PoC) versus lab-based) because the 

risks associated with each device are 

different. 

The performance criteria FDA 

proposed and finalized for HCV 

antibody tests and nucleic acid-based 

HCV RNA tests have been demonstrated 

to provide a reasonable assurance of 


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safety and effectiveness of these tests 

that aid in the diagnosis of HCV 

infection (see 85 FR 18483, April 2, 

2020, and 86 FR 66173, November 22, 

2021); likewise, the criteria FDA 

proposed for HIV diagnostic and 

supplemental tests have been 

demonstrated to provide a reasonable 

assurance of safety and effectiveness for 

these tests that aid in diagnosis of 

infection with HIV. Lowering 

performance criteria for HIV diagnostic 

and supplemental tests raises the risk 

that lower-performing tests, for which 

there is not a reasonable assurance of 

safety and effectiveness, will be on the 

market. Therefore, the performance 

criteria FDA is finalizing in this order 

do not mirror those FDA has finalized 

for HCV tests. 

With respect to the concerns 

expressed about the number of samples 

that will be needed to conduct the 

clinical studies, we note that the final 

special controls do not specify a 

minimum number of samples that must 

be used. The number of samples needed 

in the study is dependent on the 

performance of the assay. Although 

reclassification of these devices to class 

II may not always result in smaller 

clinical studies than were conducted for 

HIV diagnostic and supplemental tests 

approved under PMAs, we believe that 

other effects of the reclassification of 

these devices into class II, such as 

typically shorter review timelines for 

510(k) submissions, will decrease the 

burden associated with obtaining 

marketing authorization of these 

devices. For all the reasons mentioned 

above, FDA is retaining the proposed 

specificity and sensitivity performance 

criteria in this final order. 

(Comment 5) Several comments 

addressed the special control to submit 

a complaint log to FDA. One comment 

requested clarification on which devices 

would be subject to the special control, 

the timeframe for submission of the 

complaint log, and how FDA will act on 

the information included in the 

complaint log. One comment indicated 

that this information will duplicate the 

information submitted under part 803 

(21 CFR part 803), which requires the 

submission of malfunction reports. 

Another comment stated that the 

required submission of a complaint log 

to monitor decreases in test 

performance, manufacturing failures, or 

trends in false positive results is 

redundant and an unnecessary 

mitigation measure, and that current 

postmarket controls for complaint 

handling, trending, and safety reporting 

are sufficient to mitigate these risks and 

are subject to routine inspection. The 

comment further asserted that this 

special control would impose reporting 

requirements that are typically reserved 

for class III devices. 

(Response 5) The submission of the 

complaint log to FDA is not intended to 

act as a replacement for a periodic 

report that is submitted for a PMAapproved device under 21 CFR 814.84 

or to duplicate the information 

submitted to fulfill the requirements for 

medical device reports (MDRs) under 

part 803. Instead, we are requiring the 

submission of a log of the complaints a 

manufacturer receives about these 

devices that includes certain available 

information for each complaint. These 

complaints must already be reviewed 

and evaluated by manufacturers under 

21 CFR 820.198. Therefore, we expect 

that submission of this log to FDA 

should not be burdensome to 

manufacturers. We have revised the 

special controls in this final order to 

clarify that the information about each 

complaint listed at §§ 866.3956(b)(1)(iii) 

and 866.3957(b)(1)(iii) (21 CFR 

866.3956(b)(1)(iii) and 

866.3957(b)(1)(iii)) must be included in 

the log to the extent it is available and 

that the types of complaints listed in the 

parenthetical are examples of the types 

of complaints manufacturers may 

receive about these devices. 

Manufacturers may submit the 

information electronically through the 

FDA Electronic Submission Gateway or 

on paper or electronic media (e.g., CD, 

DVD) to the Center for Biologics 

Evaluation and Research Document 

Control Center. The complaint log must 

be submitted only for a period of 5 years 

following device clearance. The 

requirement does not apply to devices 

previously approved by FDA following 

submission of a PMA application. 

However, if a manufacturer of a device 

previously approved under a PMA 

subsequently submits a traditional 

510(k) for a change to that device, the 

requirement in the special controls 

would apply. The 5-year period does 

not restart because of minor changes to 

a device that do not necessitate the 

submission of a new 510(k). FDA 

intends to review the information 

submitted in the complaint logs in a 

timely way and engage with 

manufacturers as necessary. 

The submission of the complaint log 

to FDA as required in the special control 

will alert FDA to potential problems 

with devices that may not meet the 

definition of MDR reportable events 

under part 803, but that can potentially 

affect the safety and effectiveness of 

these devices. Such problems may 

include an unusually high invalid rate 

or issues with users conducting the test. 

The submission of the complaint log 

will allow FDA to be alerted earlier to 

these concerns and to whether they 

have been adequately addressed, which 

we believe is important to providing 

reasonable assurance of safety and 

effectiveness for these devices. The 

Agency usually would not evaluate this 

kind of complaint information until an 

FDA inspection, which typically occurs 

less frequently than annually. 

(Comment 6) Two comments 

indicated that the cost of conducting 

clinical trials to meet the performance 

requirements in the proposed special 

controls for HIV diagnostic and 

supplemental tests as compared to those 

proposed for HCV tests will be a 

disincentive for manufacturers to 

develop multiplex laboratory assays or 

dual point-of-care assays with both 

analytes. It was noted that, with the 

high burden of co-occurring HIV and 

HCV infection, the capability to fully 

and efficiently integrate diagnostic 

testing for HIV and HCV is essential. 

(Response 6) FDA supports efforts to 

integrate diagnostic testing for HIV and 

HCV. However, as noted in Response 4 

of this final order, the performance 

necessary to provide a reasonable 

assurance of safety and effectiveness of 

in vitro diagnostic devices is based on, 

among other things, the analyte, the 

disease or condition for which the 

particular device is intended to be used 

in diagnosis, and the conditions of use. 

Accordingly, the performance criteria 

necessary to provide a reasonable 

assurance of safety and effectiveness for 

an HIV diagnostic or supplemental test 

are reflected in this final order. Device 

manufacturers with questions on their 

plans for development of multiplex 

devices for HIV and HCV, including on 

the design of clinical studies, can 

request FDA feedback through the QSubmission Program (Ref. 1). 

(Comment 7) One comment noted that 

the proposed reclassification of HIV 

diagnostic and supplemental tests from 

class III to class II with special controls 

decreases some regulatory burden, 

including the reduced costs associated 

with a 510(k), compared to a PMA and 

supplements. However, the comment 

expressed concern that considerable 

burden remains associated with the cost 

of clinical trials to demonstrate the 

required performance criteria and to add 

a new specimen type, for example a 

dried blood spot, to a marketed device. 

The comment asserted that the clinical 

trial required to add a new specimen 

type under the proposed regulatory 

pathway would be equivalent to the 

current pathway and would be a 

disincentive to manufacturers to address 

changing needs in the field by 


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29664 Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. This change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

submitting changes to their original 

submission. 

(Response 7) FDA concurs that 

reclassification of HIV diagnostic and 

supplemental tests from class III to class 

II with special controls will reduce 

regulatory burdens as manufacturers 

will no longer be required to submit a 

PMA but can instead submit a 510(k) 

and receive clearance before marketing 

their device. However, we decline to 

revise the special controls necessary to 

provide a reasonable assurance of safety 

and effectiveness of these devices for 

the reasons discussed in Response 4 

above. FDA remains open to discussions 

with device manufacturers about 

clinical study designs. 

(Comment 8) One comment objected 

to requiring prescriptions for HIV 

diagnostic testing, noting that the 

requirement would result in more HIV 

transmissions. 

(Response 8) FDA believes that the 

reclassification of HIV diagnostic and 

supplemental tests to class II with 

special controls will provide a 

reasonable assurance of safety and 

effectiveness of these devices while 

expanding access to HIV testing and 

reducing the regulatory burden on 

manufacturers. Under this final order, 

the HIV serological diagnostic and 

supplemental tests and HIV NAT 

diagnostic and supplemental tests 

subject to this reclassification are 

identified as prescription use only 

devices. There are different performance 

considerations and risks associated with 

non-prescription HIV diagnostic and 

supplemental tests. Although not 

subject to this final order, FDA has 

approved one home-use device for 

which a prescription is not required. 

III. Final Order 

Based on the information discussed in 

the preamble to the proposed order (85 

FR 10110), the comments received on 

the proposed order, the Panel 

discussions (Ref. 2), and FDA’s 

experiences over the years with these 

device types, FDA concludes that 

special controls, in conjunction with 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of HIV serological 

diagnostic and supplemental tests and 

HIV NAT diagnostic and supplemental 

tests. FDA is adopting its findings under 

section 513(f)(3) of the FD&C Act, as 

published in the preamble to the 

proposed order (85 FR 10110). 

FDA is issuing this final order to 

reclassify certain HIV serological 

diagnostic and supplemental tests and 

HIV NAT diagnostic and supplemental 

tests from class III into class II and to 

establish special controls that will be 

codified at §§ 866.3956 and 866.3957.1

In this final order, the Agency has 

identified special controls under section 

513(a)(1)(B) of the FD&C Act which, 

together with general controls, provide 

a reasonable assurance of the safety and 

effectiveness of HIV serological and 

NAT diagnostic and supplemental tests. 

FDA is making a few clarifications 

and modifications to the special 

controls as published in the proposed 

order after considering public 

comments, as discussed above, and on 

its own initiative. These include: (1) 

Correcting a reference to ‘‘prescription 

use only’’ in § 866.3957(a) to read ‘‘for 

professional use only’’ and moving the 

placement of the text stating the tests 

are for professional use only within both 

§§ 866.3956(a) and 866.3957(a); (2) 

referring to ‘‘blood products’’ instead of 

‘‘plasma’’ in § 866.3956(a) and 

(b)(1)(i)(A) and in § 866.3957(a) and 

(b)(1)(i)(A) for consistency with the 

labeling of more recently approved tests; 

(3) clarifying in §§ 866.3956(b)(1)(v)(A) 

and 866.3957(b)(1)(v)(A) that multisite 

clinical studies required for devices 

intended for PoC use must be conducted 

at appropriate PoC sites; (4) clarifying 

that the procedures for determining 

when to submit an MDR described in 

§ 866.3956(b)(1)(ii)(K) and in 

§ 866.3957(b)(1)(ii)(K) must be 

appropriate and acceptable so that they 

ensure appropriate adverse event 

reporting; (5) clarifying certain aspects 

of the special controls regarding 

submission of complaint log; (6) adding 

references to ‘‘labeling’’ in 

§ 866.3956(b)(2), (b)(3), and (b)(5) and in 

§ 866.3957(b)(2), (b)(3), and (b)(5) to 

make clearer that certain required 

statements must be included in the 

device labeling and making other minor 

wording changes to labeling statements 

required under §§ 866.3956(b)(2) and 

866.3957(b)(2); (7) changing references 

to the PoC or supplemental ‘‘claim’’ to 

‘‘PoC use’’ or ‘‘supplemental use’’ for 

consistency with terminology used 

elsewhere in the special controls; and 

(8) identifying more clearly that certain 

information must be included in 510(k) 

submissions for HIV diagnostic and 

supplemental tests. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

FDA has determined that premarket 

notification is necessary to provide a 

reasonable assurance of the safety and 

effectiveness of HIV serological 

diagnostic and supplemental tests and 

HIV NAT diagnostic and supplemental 

tests. Therefore, these device types are 

not exempt from premarket notification 

requirements. Persons who intend to 

market theses device types must submit 

and obtain clearance of a premarket 

notification and demonstrate 

compliance with the special controls in 

this final order, prior to marketing the 

device. 

The devices that are the subject of this 

reclassification are assigned the generic 

names ‘‘human immunodeficiency virus 

(HIV) serological diagnostic and 

supplemental tests’’ and ‘‘human 

immunodeficiency virus (HIV) nucleic 

acid (NAT) diagnostic and supplemental 

tests.’’ HIV serological diagnostic and 

supplemental tests are identified as 

prescription devices for the qualitative 

detection of HIV antigen(s) and/or 

detection of antibodies against HIV in 

human body fluids or tissues. HIV NAT 

diagnostic and supplemental tests are 

identified as prescription devices for the 

qualitative detection of HIV nucleic acid 

in human body fluids or tissues. HIV 

serological diagnostic and supplemental 

tests and the NAT diagnostic and 

supplemental tests are intended for use 

as an aid in the diagnosis of infection 

with HIV, and their results are intended 

to be interpreted in conjunction with 

other relevant clinical and laboratory 

findings. These tests are for professional 

use only and are not intended to be used 

for monitoring patient status or for 

screening donors of blood or blood 

products, or human cells, tissues, and 

cellular and tissue-based products 

(HCT/Ps). 

Under this final order, the HIV 

serological diagnostic and supplemental 

tests and HIV NAT diagnostic and 

supplemental tests are identified as 

prescription use only devices. 

Prescription in vitro diagnostic devices 

are exempt from the requirement for 

adequate directions for use under 

section 502(f)(1) of the FD&C Act (21 

U.S.C. 352(f)(1)) and 21 CFR 801.5, as 

long as all the conditions of 21 CFR 

801.109 are met. A premarket 

notification submission for these 

devices will be required in the 

circumstances described in 21 CFR 

807.81. 


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IV. Codification of Orders 

Under section 513(f)(3) of the FD&C 

Act, FDA may issue final orders to 

reclassify devices. FDA will continue to 

codify classifications and 

reclassifications in the Code of Federal 

Regulations (CFR). Changes resulting 

from final orders will appear in the CFR 

as newly codified orders. In accordance 

with section 513(f)(3) of the FD&C Act, 

we are codifying in this final order the 

classification of HIV serological 

diagnostic and supplemental tests in the 

new § 866.3956, under which these 

devices are reclassified from class III to 

class II. In addition, we are codifying 

the classification of HIV NAT diagnostic 

and supplemental tests in the new 

§ 866.3957, under which these devices 

are reclassified from class III to class II. 

V. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Paperwork Reduction Act of 1995 

This final order contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The information collection 

provisions in §§ 866.3956(b)(1)(iii) and 

866.3957(b)(1)(iii) have been approved 

under OMB control number 0910–0437. 

This approval expires on March 31, 

2025. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

This final order also refers to 

previously approved FDA collections of 

information. These collections of 

information are subject to review by the 

OMB under the PRA. The collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information in part 803 

have been approved under OMB control 

number 0910–0437; and the collections 

of information in 21 CFR parts 801 and 

809 have been approved under OMB 

control number 0910–0485. 

VII. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https:// 

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Requests for Feedback and Meetings 

for Medical Device Submissions: The QSubmission Program,’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/requests-feedback-andmeetings-medical-device-submissions-qsubmission-program. 

2. Transcript of the July 19, 2018, Meeting of 

the Blood Products Advisory Committee 

(BPAC), available at: https://www.fda.gov/ 

AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

BloodVaccinesandOtherBiologics/ 

BloodProductsAdvisoryCommittee/ 

ucm597841.htm. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 866.3956 to subpart D to read 

as follows: 

§ 866.3956 Human immunodeficiency virus 

(HIV) serological diagnostic and/or 

supplemental test. 

(a) Identification. Human 

immunodeficiency virus (HIV) 

serological diagnostic and supplemental 

tests are prescription devices for the 

qualitative detection of HIV antigen(s) 

and/or detection of antibodies against 

HIV in human body fluids or tissues. 

The tests are intended for use as an aid 

in the diagnosis of infection with HIV 

and are for professional use only. The 

test results are intended to be 

interpreted in conjunction with other 

relevant clinical and laboratory 

findings. These tests are not intended to 

be used for monitoring patient status, or 

for screening donors of blood or blood 

products, or human cells, tissues, and 

cellular and tissue-based products 

(HCT/Ps). 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) For all HIV serological diagnostic 

and supplemental tests 

(i) The labeling must include: 

(A) An intended use that states that 

the device is not intended for use for 

screening donors of blood or blood 

products or HCT/Ps. 

(B) A detailed explanation of the 

principles of operation and procedures 

used for performing the assay. 

(C) A detailed explanation of the 

interpretation of results and 

recommended actions to take based on 

results. 

(D) Limitations, which must be 

updated to reflect current clinical 

practice and disease presentation and 

management. The limitations must 

include, but are not limited to, 

statements that indicate: 

(1) The matrices with which the 

device has been cleared, and that use of 

this test kit with specimen types other 

than those specifically cleared for this 

device may result in inaccurate test 

results. 

(2) The test is not intended to be used 

to monitor individuals who are 

undergoing treatment for HIV infection. 

(3) A specimen with a reactive result 

should be investigated further following 

current guidelines. 

(4) All test results should be 

interpreted in conjunction with the 

individual’s clinical presentation, 

history, and other laboratory results. 

(5) A test result that is nonreactive 

does not exclude the possibility of 

exposure to or infection with HIV. 

Nonreactive results in this assay may be 

due to analyte levels that are below the 

limit of detection of this assay. 

(ii) Device verification and validation 

must include: 

(A) Detailed device description, 

including the device components, 

ancillary reagents required but not 

provided, and an explanation of the 

methodology. Additional information 

appropriate to the technology must be 

included, such as the amino acid 

sequence of antigen(s) and design of 

capture antibodies. 

(B) For devices with assay calibrators, 

the design of all primary, secondary, 

and subsequent quantitation standards 

used for calibration as well as their 

traceability to a reference material. In 

addition, analytical testing must be 

performed following the release of a 

new lot of the standard material that 

was used for device clearance, or when 

there is a transition to a new calibration 

standard. 

(C) Detailed documentation of 

analytical performance studies 


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conducted as appropriate to the 

technology, specimen types tested, and 

intended use of the device, including, 

but not limited to, limit of blank, limit 

of detection, cutoff determination, 

precision, endogenous and exogenous 

interferences, cross reactivity, carryover, 

quality control, matrix equivalency, and 

sample and reagent stability. Samples 

selected for use in analytical studies or 

used to prepare samples for use in 

analytical studies must be from subjects 

with clinically relevant circulating 

genotypes in the United States. 

(D) Multisite reproducibility study 

that includes the testing of three 

independent production lots. 

(E) Analytical sensitivity of the test 

must be the same as or better than that 

of other cleared or approved tests. 

Samples tested must include 

appropriate numbers and types of 

samples, including real clinical samples 

near the lower limit of detection. 

Analytical specificity of the test must be 

the same as or better than that of other 

cleared or approved tests. Samples must 

include appropriate numbers and types 

of samples from patients with different 

underlying illnesses or infections and 

from patients with potential endogenous 

interfering substances. 

(F) Detailed documentation of 

performance from a multisite clinical 

study. Performance must be analyzed 

relative to an FDA-cleared or approved 

comparator. This study must be 

conducted using patient samples, with 

an appropriate number of HIV positive 

and HIV negative samples in applicable 

risk categories. Additional subgroups or 

types must be validated using 

appropriate numbers and types of 

samples. The samples may be a 

combination of fresh and repository 

samples, sourced from within and 

outside the United States, as 

appropriate. The study designs, 

including number of samples tested, 

must be sufficient to meet the following 

criteria: 

(1) Clinical sensitivity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 99 percent. 

(2) Clinical specificity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 99 percent. 

(G) Strategies for detection of new 

strains, types, subtypes, genotypes, and 

genetic mutations as they emerge. 

(H) Risk analysis and management 

strategies, such as Failure Modes Effects 

Analysis and/or Hazard Analysis and 

Critical Control Points summaries and 

their impact on test performance. 

(I) Final release criteria to be used for 

manufactured test lots with appropriate 

evidence that lots released at the 

extremes of the specifications will meet 

the claimed analytical and clinical 

performance characteristics as well as 

the stability claims. 

(J) All stability protocols, including 

acceptance criteria. 

(K) Appropriate and acceptable 

procedure(s) for evaluating customer 

complaints and other device 

information that determines when to 

submit a medical device report. 

(L) Premarket notification 

submissions must include the 

information contained in paragraph 

(b)(1)(ii)(A) through (K) of this section. 

(iii) Manufacturers must submit a log 

of all complaints. The log must include 

the following information regarding 

each complaint if available: The type of 

event (e.g., false negative/false 

nonreactive or false positive/false 

reactive), lot, date, population, and 

whether or not the complaint was 

reported under part 803 of this chapter 

(Medical Device Reporting). The log 

must be submitted annually on the 

anniversary of clearance for 5 years 

following clearance of a traditional 

premarket notification. 

(2) If the test is intended for Point of 

Care (PoC) use, the following special 

controls, in addition to those listed in 

paragraph (b)(1) of this section apply: 

(i) The PoC labeling must include a 

statement that the test is intended for 

PoC use. 

(ii) The PoC labeling must include the 

following information near the 

statement of the intended use: 

(A) That the test is for distribution to 

clinical laboratories that have an 

adequate quality assurance program, 

including planned systematic activities 

that provide adequate confidence that 

requirements for quality will be met and 

where there is assurance that operators 

will receive and use the instructional 

materials. 

(B) That the test is for use only by an 

agent of a clinical laboratory. 

(C) Instructions for individuals to 

receive the ‘‘Subject Information 

Notice’’ prior to specimen collection 

and appropriate information when test 

results are provided. 

(iii) PoC labeling must include 

instructions to follow current guidelines 

for informing the individual of the test 

result and its interpretation. 

(iv) The instructions in the labeling 

must state that reactive results are 

considered preliminary and should be 

confirmed following current guidelines. 

(v) Device verification and validation 

for PoC use must include: 

(A) Detailed documentation of 

performance from a multisite clinical 

study conducted at appropriate PoC 

sites. Performance must be analyzed 

relative to an FDA cleared or approved 

comparator. This study must be 

conducted using patient samples, with 

appropriate numbers of HIV positive 

and HIV negative samples in applicable 

risk categories. Additional subgroup or 

type claims must be validated using 

appropriate numbers and types of 

samples. The samples may be a 

combination of fresh and repository 

samples, sourced from within and 

outside the United States, as 

appropriate. If the test is intended solely 

for PoC use, the test must meet only the 

performance criteria in paragraphs 

(b)(2)(v)(A)(1) and (2) of this section and 

not the criteria in paragraph (b)(1)(ii)(F) 

of this section: 

(1) Clinical sensitivity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 98 percent. 

(2) Clinical specificity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 98 percent. 

(B) Premarket notification 

submissions must include the 

information contained in paragraph 

(b)(2)(v)(A) of this section. 

(3) If the test is intended for 

supplemental use in addition to use as 

an aid in initial diagnosis, the following 

special controls, in addition to those 

listed in paragraphs (b)(1) and (2) of this 

section, as appropriate, apply: 

(i) The labeling must include a 

statement that the test is intended for 

use as an additional test to confirm the 

presence of HIV antibodies or antigens 

in specimens found to be repeatedly 

reactive by a diagnostic screening test. 

(ii) Device validation and verification 

for supplemental use must include a 

clinical study, including samples that 

were initially reactive and repeatedly 

reactive on a diagnostic test but were 

negative or indeterminate on a different 

confirmatory test. Premarket notification 

submissions must include this 

information. 

(4) If the test is intended solely as a 

supplemental test, the following special 

controls, in addition to those listed in 

paragraphs (b)(1) and (2) of this section, 

except those in paragraphs (b)(1)(ii)(F) 

and (b)(2)(v)(A) of this section, as 

appropriate, apply: 

(i) The labeling must include a 

statement that the test is intended for 

use as an additional test to confirm the 

presence of HIV antibodies or antigens 

in specimens found to be repeatedly 

reactive by a diagnostic screening test. 

(ii) The labeling must clearly state 

that the test is not for use for initial 

diagnosis or is not intended as a firstline test. 


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Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 29667 

(iii) Device validation and verification 

must include a clinical study including 

samples that were initially reactive and 

repeatedly reactive on a diagnostic test 

but were negative or indeterminate on a 

confirmatory test. Premarket notification 

submissions must include this 

information. 

(5) If the test is intended to 

differentiate different HIV types, the 

following special controls, in addition 

to those listed in paragraphs (b)(1) 

through (4) of this section, as 

appropriate, apply: 

(i) The labeling must include the 

statement that the test is intended for 

the confirmation of initial results from 

a diagnostic test and differentiation of 

different HIV types. 

(ii) The results interpretation in the 

labeling must include instructions for 

the user on how to interpret the results, 

including un-typeable and co-infection 

results. 

(iii) Device validation and verification 

must include evaluation of analytical 

and clinical sensitivity and specificity 

for each of the HIV types, strains, and 

subtypes of HIV intended to be 

differentiated. Premarket notification 

submissions must include this 

information. 

■ 3. Add § 866.3957 to subpart D to read 

as follows: 

§ 866.3957 Human immunodeficiency virus 

(HIV) nucleic acid (NAT) diagnostic and/or 

supplemental test. 

(a) Identification. Human 

immunodeficiency virus (HIV) nucleic 

acid (NAT) diagnostic and supplemental 

tests are prescription devices for the 

qualitative detection of HIV nucleic acid 

in human body fluids or tissues. The 

tests are intended for use as an aid in 

the diagnosis of infection with HIV and 

are for professional use only. The test 

results are intended to be interpreted in 

conjunction with other relevant clinical 

and laboratory findings. These tests are 

not intended to be used for monitoring 

patient status, or for screening donors of 

blood or blood products, or human 

cells, tissues, or cellular or tissue-based 

products (HCT/Ps). 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) For all HIV NAT diagnostic and/ 

or supplemental tests 

(i) The labeling must include: 

(A) An intended use that states that 

the device is not intended for use for 

screening donors of blood or blood 

products, or HCT/Ps. 

(B) A detailed explanation of the 

principles of operation and procedures 

used for performing the assay. 

(C) A detailed explanation of the 

interpretation of results and 

recommended actions to take based on 

results. 

(D) Limitations, which must be 

updated to reflect current clinical 

practice and disease presentation and 

management. The limitations must 

include, but are not limited to, 

statements that indicate: 

(1) The matrices with which the 

device has been cleared, and that use of 

this test kit with specimen types other 

than those specifically cleared for this 

device may result in inaccurate test 

results. 

(2) The test is not intended to be used 

to monitor individuals who are 

undergoing treatment for HIV infection. 

(3) A specimen with a reactive result 

should be investigated further following 

current guidelines. 

(4) All test results should be 

interpreted in conjunction with the 

individual’s clinical presentation, 

history, and other laboratory results. 

(5) A test result that is nonreactive 

does not exclude the possibility of 

exposure to or infection with HIV. 

Nonreactive results in this assay may be 

due to analyte levels that are below the 

limit of detection of this assay. 

(ii) Device verification and validation 

must include: 

(A) Detailed device description, 

including the device components, 

ancillary reagents required but not 

provided, and an explanation of the 

methodology. Additional information 

appropriate to the technology must be 

included, such as design of primers and 

probes. 

(B) For devices with assay calibrators, 

the design and nature of all primary, 

secondary, and subsequent quantitation 

standards used for calibration as well as 

their traceability to a reference material. 

In addition, analytical testing must be 

performed following the release of a 

new lot of the standard material that 

was used for device clearance, or when 

there is a transition to a new calibration 

standard. 

(C) Detailed documentation of 

analytical performance studies 

conducted as appropriate to the 

technology, specimen types tested, and 

intended use of the device, including, 

but not limited to, limit of blank, limit 

of detection, cutoff determination, 

precision, endogenous and exogenous 

interferences, cross reactivity, carryover, 

quality control, matrix equivalency, and 

sample and reagent stability. Samples 

selected for use in analytical studies or 

used to prepare samples for use in 

analytical studies must be from subjects 

with clinically relevant circulating 

genotypes in the United States. The 

effect of each claimed nucleic-acid 

isolation and purification procedure on 

detection must be evaluated. 

(D) Multisite reproducibility study 

that includes the testing of three 

independent production lots. 

(E) Analytical sensitivity of the test 

must be the same as or better than that 

of other cleared or approved tests. 

Samples tested must include 

appropriate numbers and types of 

samples, including real clinical samples 

near the lower limit of detection. 

Analytical specificity of the test must be 

as the same as or better than that of 

other cleared or approved tests. Samples 

must include appropriate numbers and 

types of samples from patients with 

different underlying illnesses or 

infections and from patients with 

potential endogenous interfering 

substances. 

(F) Detailed documentation of 

performance from a multisite clinical 

study. Performance must be analyzed 

relative to an FDA cleared or approved 

comparator. This study must be 

conducted using appropriate patient 

samples, with appropriate numbers of 

HIV positive and negative samples in 

applicable risk categories. Additional 

subtype, strain, or types must be 

validated using appropriate numbers 

and types of samples. The samples may 

be a combination of fresh and repository 

samples, sourced from within and 

outside the United States, as 

appropriate. The study designs, 

including number of samples tested, 

must be sufficient to meet the following 

criteria: 

(1) Clinical sensitivity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 99 percent. 

(2) Clinical specificity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 99 percent. 

(G) Strategies for detection of new 

strains, types, subtypes, genotypes, and 

genetic mutations as they emerge. 

(H) Risk analysis and management 

strategies, such as Failure Modes Effects 

Analysis and/or Hazard Analysis and 

Critical Control Points summaries and 

their impact on test performance. 

(I) Final release criteria to be used for 

manufactured test lots with appropriate 

evidence that lots released at the 

extremes of the specifications will meet 

the claimed analytical and clinical 

performance characteristics as well as 

the stability claims. 

(J) All stability protocols, including 

acceptance criteria. 

(K) Appropriate and acceptable 

procedure(s) for evaluating customer 

complaints and other device 


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29668 Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 

information that determine when to 

submit a medical device report. 

(L) Premarket notification 

submissions must include the 

information contained in paragraph 

(b)(1)(ii)(A) through (K) of this section. 

(iii) Manufacturers must submit a log 

of all complaints. The log must include 

the following information regarding 

each complaint, if available: The type of 

event (e.g., false negative/false 

nonreactive or false positive/false 

reactive), lot, date, population, and 

whether or not the complaint was 

reported under part 803 of this chapter 

(Medical Device Reporting). The log 

must be submitted annually on the 

anniversary of clearance for 5 years 

following clearance of a traditional 

premarket notification. 

(2) If the test is intended for Point of 

Care (PoC) use, the following special 

controls, in addition to those listed in 

paragraph (b)(1) of this section, apply: 

(i) The PoC labeling must include a 

statement that the test is intended for 

PoC use. 

(ii) The PoC labeling must include the 

following information near the 

statement of the intended use: 

(A) That the test is for distribution to 

clinical laboratories that have an 

adequate quality assurance program, 

including planned systematic activities 

that provide adequate confidence that 

requirements for quality will be met and 

where there is assurance that operators 

will receive and use the instructional 

materials. 

(B) That the test is for use only by an 

agent of a clinical laboratory. 

(C) Instructions for individuals to 

receive the ‘‘Subject Information 

Notice’’ prior to specimen collection 

and appropriate information when test 

results are provided. 

(iii) PoC labeling must include 

instructions to follow current guidelines 

for informing the individual of the test 

result and its interpretation. 

(iv) The instructions in the labeling 

must state that reactive results are 

considered preliminary and should be 

confirmed following current guidelines. 

(v) Device verification and validation 

for PoC use must include: 

(A) Detailed documentation from a 

well-conducted multisite clinical study 

conducted at appropriate PoC sites. 

Performance must be analyzed relative 

to an FDA cleared or approved 

comparator. This study must be 

conducted using patient samples, with 

appropriate numbers of HIV positive 

and HIV negative samples in applicable 

risk categories. Additional subgroup or 

type claims must be validated using 

appropriate numbers and types of 

samples. The samples may be a 

combination of fresh and repository 

samples, sourced from within and 

outside the United States, as 

appropriate. If the test is intended solely 

for PoC use, the test must meet only the 

performance criteria in paragraphs 

(b)(2)(v)(A)(1) and (2) of this section and 

not the criteria in paragraph (b)(1)(ii)(F) 

of this section: 

(1) Clinical sensitivity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 98 percent. 

(2) Clinical specificity of the test must 

have a lower bound of the 95 percent 

confidence interval of greater than or 

equal to 98 percent. 

(B) Premarket notification 

submissions must include the 

information contained in paragraph 

(b)(2)(v)(A) of this section. 

(3) If the test is intended for 

supplemental use in addition to use as 

an aid in initial diagnosis, the following 

special controls, in addition to those 

listed in paragraphs (b)(1) and (2) of this 

section, as appropriate, apply: 

(i) The labeling must include a 

statement that the test is intended for 

use as an additional test to confirm the 

presence of HIV viral nucleic acid in 

specimens found to be repeatedly 

reactive by a diagnostic screening test. 

(ii) Device validation and verification 

for supplemental use must include a 

clinical study, including samples that 

were initially reactive and repeatedly 

reactive on a diagnostic test but were 

negative or indeterminate on a 

confirmatory test. Premarket notification 

submissions must include this 

information. 

(4) If the test is intended solely as a 

supplemental test, the following special 

controls, in addition to those listed in 

paragraphs (b)(1) and (2) of this section, 

except those in paragraphs (b)(1)(ii)(F) 

and (b)(2)(v)(A) of this section, as 

appropriate, apply: 

(i) The labeling must include a 

statement that the test is intended for 

use as an additional test to confirm the 

presence of HIV viral nucleic acid in 

specimens found to be repeatedly 

reactive by a diagnostic screening test. 

(ii) The labeling must clearly state 

that the test is not for use for initial 

diagnosis or is not intended as a firstline test. 

(iii) Device validation and verification 

must include a clinical study including 

samples that were initially reactive and 

repeatedly reactive on a diagnostic test 

but were negative or indeterminate on a 

confirmatory test. Premarket notification 

submissions must include this 

information. 

(5) If the test is intended to 

differentiate different HIV types, the 

following special controls, in addition 

to those listed in paragraphs (b)(1) 

through (4) of this section, as 

appropriate, apply: 

(i) The labeling must include the 

statement that the test is intended for 

the confirmation of initial results and 

differentiation of different HIV types. 

(ii) The results interpretation in the 

labeling must include instructions for 

the user on how to interpret the results, 

including un-typeable and co-infection 

results. 

(iii) Device validation and verification 

must include evaluation of analytical 

and clinical sensitivity and specificity 

for each of the types, strains, and 

subtypes of HIV intended to be 

differentiated. Premarket notification 

submissions must include this 

information. 

Dated: May 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10461 Filed 5–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 110 

[Docket Number USCG–2020–0154] 

RIN 1625–AA01 

Anchorage Regulations; Ten 

Anchorages on the Mississippi River 

Mile Markers 12–85 AHP 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

anchorage regulations for the Lower 

Mississippi River (LMR) between mile 

marker (MM) 12 above head of passes 

(AHP), to MM 85 AHP. This amendment 

modifies nine anchorage grounds and 

establishes one new anchorage ground. 

This regulation increases the available 

anchorage areas necessary to 

accommodate vessel traffic, promote 

navigational safety, provide for the 

overall safe and efficient flow of vessel 

traffic and commerce, and bolster the 

economy through increased anchorage 

capacity. 

DATES: This rule is effective June 15, 

2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2020– 

0154 in the search box and click 


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