6422 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 

(6) Software verification, validation, 

and hazard analysis must be performed. 

(7) Performance data must support 

shelf life by demonstrating continued 

sterility of the device or the sterile 

components, package integrity, and 

device functionality over the identified 

shelf life. 

(8) Human factors testing and analysis 

must validate that the device design and 

labeling are sufficient for the end user. 

(9) Physician labeling must include: 

(i) The operating parameters, name, 

and model number of the indicated 

external dosage controller; 

(ii) Information on how the device 

operates and the typical course of 

treatment; 

(iii) Information on the population for 

which the device has been 

demonstrated to be effective; 

(iv) A detailed summary of the device 

technical parameters; and 

(v) Provisions for choosing an 

appropriate size implant that would be 

exchanged for the tissue expander. 

(10) Patient labeling must include: 

(i) Warnings, precautions, and 

contraindications, and adverse events/ 

complications; 

(ii) Information on how the device 

operates and the typical course of 

treatment; 

(iii) The probable risks and benefits 

associated with the use of the device; 

(iv) Post-operative care instructions; 

and 

(v) Alternative treatments. 

(11) Patient training must include 

instructions for device use, when it may 

be necessary to contact a physician, and 

cautionary measures to take when the 

device is implanted. 

Dated: January 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02357 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 880 

[Docket No. FDA–2021–N–0998] 

Medical Devices; General Hospital and 

Personal Use Devices; Classification 

of the Alternate Controller Enabled 

Infusion Pump 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the alternate controller 

enabled infusion pump into class II 

(special controls). The special controls 

that apply to the device type are 

identified in this order and will be part 

of the codified language for the alternate 

controller enabled infusion pump’s 

classification. We are taking this action 

because we have determined that 

classifying the device into class II 

(special controls) will provide a 

reasonable assurance of safety and 

effectiveness of the device. We believe 

this action will also enhance patients’ 

access to beneficial innovative devices. 

DATES:

Effective date: This order is effective 

February 4, 2022. 

Applicability date: The classification 

was applicable on February 14, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Ryan Lubert, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3574, Silver Spring, 

MD 20993–0002, 240–402–6357, 

Ryan.Lubert@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

alternate controller enabled infusion 

pump as class II (special controls), 

which we have determined will provide 

a reasonable assurance of safety and 

effectiveness. In addition, we believe 

this action will enhance patients’ access 

to beneficial innovation, by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 

section 513(f)(2)(B)(i) of the FD&C Act). 

As a result, other device sponsors do not 

have to submit a De Novo request or 

premarket approval application to 

market a substantially equivalent device 

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

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On October 29, 2018, FDA received 

Tandem Diabetes Care, Inc.’s request for 

De Novo classification of the t:slim X2 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6423 

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. The 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. 

insulin pump with interoperable 

technology. FDA reviewed the request 

in order to classify the device under the 

criteria for classification set forth in 

section 513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the generals controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on February 14, 2019, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 880.5730.1 We have named the 

generic type of device ‘‘alternate 

controller enabled infusion pump,’’ and 

it is identified as an alternate controller 

enabled infusion pump (ACE pump). 

The ACE pump is a device intended for 

the infusion of drugs into a patient. The 

ACE pump may include basal and bolus 

drug delivery at set or variable rates. 

ACE pumps are designed to reliably and 

securely communicate with external 

devices, such as automated drug dosing 

systems, to allow drug delivery 

commands to be received, executed, and 

confirmed. ACE pumps are intended to 

be used both alone and in conjunction 

with digitally connected devices for the 

purpose of drug delivery. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—ALTERNATE CONTROLLER ENABLED INFUSION PUMP RISKS AND MITIGATION MEASURES

Identified risk Mitigation measures 

Patient harm due to inadequate drug delivery accuracy that leads to 

over infusion or under infusion of drug.

Basal and bolus drug delivery accuracy validation testing, Device use 

life reliability testing, Design mitigations to prevent cross-channeling. 

Validated and traceable risk control measures for identified hazards. 

Patient harm due to undetected pump occlusions that pose risk of 

under infusion of drug.

Hazard detection (e.g., drug occlusion) validation testing. 

Patient harm due to incompatibility between the drug and the pump 

that may lead to over infusion or under infusion of drug, or exposure 

to harmful substances leached from pump materials into the infused 

drug solution.

Drug compatibility testing. 

Inability to provide appropriate treatment due to loss of communication 

with digitally connected alternate pump controller devices.

Validated communication specifications, processes, and procedures 

with digitally connected devices. 

Commands from the digitally connected alternate pump controller devices that conflict with existing pump commands may lead to unintended over or under infusion of drug.Validated communication specifications, processes, and procedures 

with digitally connected devices, Validated failsafe design features. 

Conflicting interfaces resulting in over or under delivery ......................... Validated communication specifications, processes, and procedures 

with digitally connected devices, Validated failsafe design features. 

Patient harm due to insecure transmission of data ................................. Validated communication specifications, processes, and procedures 

with digitally connected devices. 

Patient harm due to inability to determine source of dosing error when 

used in an integrated system.

Validated data logging capability. 

Patient harm due to exposure to hazardous and non-biocompatible materials or pathogens.Biocompatibility testing, Validation of reprocessing procedures. 

Patient harm due to data transmission interference/electromagnetic disturbance.Electrical safety, electromagnetic compatibility, and radio frequency 

wireless safety testing. 

Patient harm due to incorrect use of pump, operational, and/or use-related errors.Human Factors testing, Transparent pump performance descriptions in 

labeling. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. This device is subject to 

premarket notification requirements 

under section 510(k) of the FD&C Act. 

III. 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. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in the 

guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 


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6424 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 

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, regarding the quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801 regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 880 

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 880 is 

amended as follows: 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

■ 1. The authority citation for part 880 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 880.5730 to subpart F to read 

as follows: 

§ 880.5730 Alternate controller enabled 

infusion pump. 

(a) Identification. An alternate 

controller enabled infusion pump (ACE 

pump) is a device intended for the 

infusion of drugs into a patient. The 

ACE pump may include basal and bolus 

drug delivery at set or variable rates. 

ACE pumps are designed to reliably and 

securely communicate with external 

devices, such as automated drug dosing 

systems, to allow drug delivery 

commands to be received, executed, and 

confirmed. ACE pumps are intended to 

be used both alone and in conjunction 

with digitally connected medical 

devices for the purpose of drug delivery. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Design verification and validation 

must include the following: 

(i) Evidence demonstrating that 

device infusion delivery accuracy 

conforms to defined user needs and 

intended uses and is validated to 

support safe use under actual use 

conditions. 

(A) Design input requirements must 

include delivery accuracy specifications 

under reasonably foreseeable use 

conditions, including ambient 

temperature changes, pressure changes 

(e.g., head-height, backpressure, 

atmospheric), and, as appropriate, 

different drug fluidic properties. 

(B) Test results must demonstrate that 

the device meets the design input 

requirements for delivery accuracy 

under use conditions for the 

programmable range of delivery rates 

and volumes. Testing shall be 

conducted with a statistically valid 

number of devices to account for 

variation between devices. 

(ii) Validation testing results 

demonstrating the ability of the pump to 

detect relevant hazards associated with 

drug delivery and the route of 

administration (e.g., occlusions, air in 

line, etc.) within a clinically relevant 

timeframe across the range of 

programmable drug delivery rates and 

volumes. Hazard detection must be 

appropriate for the intended use of the 

device and testing must validate 

appropriate performance under the 

conditions of use for the device. 

(iii) Validation testing results 

demonstrating compatibility with drugs 

that may be used with the pump based 

on its labeling. Testing must include 

assessment of drug stability under 

reasonably foreseeable use conditions 

that may affect drug stability (e.g., 

temperature, light exposure, or other 

factors as needed). 

(iv) The device parts that directly or 

indirectly contact the patient must be 

demonstrated to be biocompatible. This 

shall include chemical and particulate 

characterization on the final, finished, 

fluid contacting device components 

demonstrating that risk of harm from 

device-related residues is reasonably 

low. 

(v) Evidence verifying and validating 

that the device is reliable over the ACE 

pump use life, as specified in the design 

file, in terms of all device functions and 

in terms of pump performance. 

(vi) The device must be designed and 

tested for electrical safety, 

electromagnetic compatibility, and radio 

frequency wireless safety and 

availability consistent with patient 

safety requirements in the intended use 

environment. 

(vii) For any device that is capable of 

delivering more than one drug, the risk 

of cross-channeling drugs must be 

adequately mitigated. 

(viii) For any devices intended for 

multiple patient use, testing must 

demonstrate validation of reprocessing 

procedures and include verification that 

the device meets all functional and 

performance requirements after 

reprocessing. 

(2) Design verification and validation 

activities must include appropriate 

design inputs and design outputs that 

are essential for the proper functioning 

of the device that have been 

documented and include the following: 

(i) Risk control measures shall be 

implemented to address device system 

hazards and the design decisions related 

to how the risk control measures impact 

essential performance shall be 

documented. 

(ii) A traceability analysis 

demonstrating that all hazards are 

adequately controlled and that all 

controls have been validated in the final 

device design. 

(3) The device shall include validated 

interface specifications for digitally 

connected devices. These interface 

specifications shall, at a minimum, 

provide for the following: 

(i) Secure authentication (pairing) to 

external devices. 

(ii) Secure, accurate, and reliable 

means of data transmission between the 

pump and connected devices. 

(iii) Sharing of necessary state 

information between the pump and any 

digitally connected alternate controllers 

(e.g., battery level, reservoir level, pump 

status, error conditions). 

(iv) Ensuring that the pump continues 

to operate safely when data is received 

in a manner outside the bounds of the 

parameters specified. 

(v) A detailed process and procedure 

for sharing the pump interface 

specification with digitally connected 

devices and for validating the correct 

implementation of that protocol. 

(4) The device must include 

appropriate measures to ensure that safe 

therapy is maintained when 

communications with digitally 

connected alternate controller devices is 

interrupted, lost, or re-established after 

an interruption (e.g., reverting to a preprogrammed, safe drug delivery rate). 

Validation testing results must 

demonstrate that critical events that 

occur during a loss of communications 

(e.g., commands, device malfunctions, 

occlusions, etc.) are handled 

appropriately during and after the 

interruption. 

(5) The device design must ensure 

that a record of critical events is stored 

and accessible for an adequate period to 

allow for auditing of communications 

between digitally connected devices and 

to facilitate the sharing of pertinent 

information with the responsible parties 

for those connected devices. Critical 

events to be stored by the system must, 

at a minimum, include: 

(i) A record of all drug delivery 

(ii) Commands issued to the pump 

and pump confirmations 

(iii) Device malfunctions 

(iv) Alarms and alerts and associated 

acknowledgements 

(v) Connectivity events (e.g., 

establishment or loss of 

communications) 

(6) Design verification and validation 

must include results obtained through a 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Rules and Regulations 6425 

human factors study that demonstrates 

that an intended user can safely use the 

device for its intended use. 

(7) Device labeling must include the 

following: 

(i) A prominent statement identifying 

the drugs that are compatible with the 

device, including the identity and 

concentration of those drugs as 

appropriate. 

(ii) A description of the minimum and 

maximum basal rates, minimum and 

maximum bolus volumes, and the 

increment size for basal and bolus 

delivery, or other similarly applicable 

information about drug delivery 

parameters. 

(iii) A description of the pump 

accuracy at minimum, intermediate, and 

maximum bolus delivery volumes and 

the method(s) used to establish bolus 

delivery accuracy. For each bolus 

volume, pump accuracy shall be 

described in terms of the number of 

bolus doses measured to be within a 

given range as compared to the 

commanded volume. An acceptable 

accuracy description (depending on the 

drug delivered and bolus volume) may 

be provided as follows for each bolus 

volume tested, as applicable: Number of 

bolus doses with volume that is <25 

percent, 25 percent to <75 percent, 75 

percent to <95 percent, 95 percent to 

<105 percent, 105 percent to <125 

percent, 125 percent to <175 percent, 

175 to 250 percent, and >250 percent of 

the commanded amount. 

(iv) A description of the pump 

accuracy at minimum, intermediate, and 

maximum basal delivery rates and the 

method(s) used to establish basal 

delivery accuracy. For each basal rate, 

pump accuracy shall be described in 

terms of the amount of drug delivered 

after the basal delivery was first 

commanded, without a warmup period, 

up to various time points. The 

information provided must include 

typical pump performance, as well as 

worst-case pump performance observed 

during testing in terms of both overdelivery and under-delivery. An 

acceptable accuracy description 

(depending on the drug delivered) may 

be provided as follows, as applicable: 

The total volume delivered 1 hour, 6 

hours, and 12 hours after starting 

delivery for a typical pump tested, as 

well as for the pump that delivered the 

least and the pump that delivered the 

most at each time point. 

(v) A description of delivery hazard 

alarm performance, as applicable. For 

occlusion alarms, performance shall be 

reported at minimum, intermediate, and 

maximum delivery rates and volumes. 

This description must include the 

specification for the longest time period 

that may elapse before an occlusion 

alarm is triggered under each delivery 

condition, as well as the typical results 

observed during performance testing of 

the pumps. 

(vi) For wireless connection enabled 

devices, a description of the wireless 

quality of service required for proper 

use of the device. 

(vii) For any infusion pumps intended 

for multiple patient reuse, instructions 

for safely reprocessing the device 

between uses. 

Dated: January 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02369 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AQ97 

Informed Consent and Advance 

Directives 

AGENCY: Department of Veterans Affairs. 

ACTION: Interim final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) published an interim final 

rule amending its regulation regarding 

informed consent and advance 

directives. In that rulemaking, we 

amended the regulation by reorganizing 

it and amending language where 

necessary to enhance clarity. We also 

made changes to facilitate the informed 

consent process, the ability to 

communicate with patients or 

surrogates through available modalities 

of communication, and the execution 

and witness requirements for a VA 

Advance Directive. Before adopting that 

interim final rule as final, VA revises 

the provision related to which 

personnel may be delegated the 

responsibility for providing a patient 

with information needed for the patient 

to make a fully informed consent 

decision. Upon further review, VA has 

determined that this provision requires 

a further change to better clarify roles in 

the team-based delivery of care model. 

We are providing the public an 

opportunity to submit comments solely 

on this amendment. 

DATES:

Effective date: This interim final rule 

is effective February 4, 2022. 

Comments due date: Comments must 

be received on or before April 5, 2022. 

ADDRESSES: Comments may be 

submitted through 

www.Regulations.gov. Comments 

received will be available at 

regulations.gov for public viewing, 

inspection, or copies. 

FOR FURTHER INFORMATION CONTACT: 

Lucinda Potter, LSW, Acting Director of 

Ethics Policy, National Center for Ethics 

in Health Care (10ETH), Veterans Health 

Administration, 810 Vermont Ave. NW, 

Washington, DC 20420; 484–678–5150. 

(This is not a toll-free number). 

SUPPLEMENTARY INFORMATION: In an 

interim final rule published May 27, 

2020 (85 FR 31690), we amended 38 

CFR 17.32, our regulation addressing 

informed consent for treatments and 

procedures, by reorganizing it and 

amending language where necessary to 

enhance clarity. We also made changes 

to facilitate the informed consent 

process, the ability to communicate 

with patients or surrogates through 

available modalities of communication, 

and the execution and witnessing for a 

VA Advance Directive. We amended the 

definition of ‘‘practitioner’’ to include 

other health care professionals whose 

scope of practice agreement or other 

formal delineation of job responsibility 

specifically permits them to obtain 

informed consent, and who are 

appropriately trained and authorized to 

perform the procedure or to provide the 

treatment for which consent is being 

obtained. 

Under the previous informed consent 

rule, the practitioner, who had primary 

responsibility for the patient or who 

would perform the particular procedure 

or provide the treatment, was 

responsible for explaining in language 

understandable to the patient or 

surrogate the nature of a proposed 

procedure or treatment; the expected 

benefits; reasonably foreseeable 

associated risks, complications or side 

effects; reasonable and available 

alternatives; and anticipated results if 

nothing is done. There was no provision 

in the rule addressing the question of 

whether, consistent with a team-based 

delivery of care model, appropriately 

trained health care team members had a 

role in the informed consent process. In 

the May 2020 interim final rule, we 

dealt with that issue in paragraph (c)(6), 

stating that the practitioner may 

delegate to other trained personnel 

responsibility for providing the patient 

with clinical information needed for the 

patient to make a fully informed consent 

decision but must personally verify with 

the patient that the patient has been 

appropriately informed and voluntarily 

consents to the treatment or procedure. 

VA intended that paragraph (c)(6) give 

the practitioner discretion to more fully 

utilize the training and expertise of nonpractitioners within the bounds of the 


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