Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47969 

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. 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– 

3520). 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 part 820 have been 

approved under OMB control number 

0910–0073, and the collections of 

information in 21 CFR parts 801 and 

809, regarding labeling have been 

approved under OMB control number 

0910–0485. 

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 § 866.2190 to subpart C to read 

as follows: 

§ 866.2190 Automated image assessment 

system for microbial colonies on solid 

culture media. 

(a) Identification. An automated 

image assessment system for microbial 

colonies on solid culture media is a 

system that is intended to assess the 

presence or absence of microbial 

colonies on solid microbiological 

culture medium, and to interpret their 

number, and phenotypic and 

morphologic characteristics through 

analysis of two dimensional digital 

images as an aid in diagnosis of 

infectious disease. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include a detailed 

description of the device, including the 

technology employed, components and 

software modules, as well as a detailed 

explanation of the result algorithms and 

any expert rules that are used to assess 

colony characteristics and enumerate 

colonies from image capture through 

end result. 

(2) Premarket notification 

submissions must include detailed 

documentation of the analytical studies 

performed to characterize device 

performance to support the intended 

use, as appropriate. 

(3) Premarket notification 

submissions must include detailed 

documentation from clinical studies 

performed on a population that is 

consistent with the intended use 

population. 

(i) The clinical studies must establish 

the device performance based on 

comparison to results obtained by an 

acceptable reference method, as 

appropriate. 

(ii) The clinical study documentation 

must include the study protocol with a 

predefined statistical analysis plan and 

the final report documenting support for 

the Indications for Use and the results 

of the statistical analysis, as appropriate. 

(4) Premarket notification 

submissions must include detailed 

documentation for device software, 

including but not limited to software 

applications and hardware based 

components that incorporate software, 

and any decision-making thresholds 

used to generate results for the device. 

If a part of a Total Laboratory 

Automation System, the premarket 

notification submission must include 

detailed documentation addressing the 

instrument and software system 

integration. 

(5) Premarket notification 

submissions must include detailed 

documentation of appropriate 

instructions for use regarding the 

intended user’s device quality control 

procedures for the instrument system 

and components, as appropriate. 

(6) The 21 CFR 809.10 compliant 

device labeling must include: 

(i) Detailed user instructions to 

mitigate the risk of failure to operate the 

instrument correctly. 

(ii) A detailed explanation of the 

interpretation of results and limitations 

regarding the need for review of culture 

plates by a qualified microbiologist, as 

appropriate. 

(iii) A summary of performance data 

obtained from the analytical studies 

used to support device performance, as 

appropriate. 

(iv) A summary of performance data 

obtained from clinical studies 

performed on a population that is 

consistent with the intended use 

population, as appropriate. 

(7) Under 21 CFR 820.30 compliant 

design control, device manufacturers 

must, as appropriate: 

(i) Conduct human factors/usability 

validation testing with the final version 

of the labeling and related materials to 

adequately mitigate the risk of failure to 

operate the instrument correctly. 

(ii) Document a device training 

program that will be offered to the end 

user to adequately mitigate the risk of 

failure to operate the instrument 

correctly. 

Dated: October 11, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22305 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2017–N–5224] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Enzyme Packed Cartridge 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the enzyme packed cartridge 

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 

enzyme packed cartridge’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, 

in part by reducing regulatory burdens. 

DATES: This order is effective October 

16, 2017. The classification was 

applicable on November 20, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Silverstein, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1615, Silver Spring, 

MD, 20993–0002, 301–796–5155, 

joshua.silverstein@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

enzyme packed cartridge as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 


jstallworth on DSKBBY8HB2PROD with RULES
47970 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens 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 (the 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 to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

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 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). 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 shall 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 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, in part by 

reducing regulatory burdens. 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 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or premarket 

approval application in order to market 

a substantially equivalent device (see 21 

U.S.C. 360c(i), defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On January 2, 2015, Alcresta, Inc. 

submitted a request for De Novo 

classification of the RELIZORBTM. 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 general 

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 general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on November 20, 2015, 

FDA issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 876.5985. We 

have named the generic type of device 

enzyme packed cartridge, and it is 

identified as an ex vivo prescription 

device that is used in enzymatic 

hydrolysis of macronutrients into their 

essential nutrient forms at the time of 

delivery. The device consists of an outer 

casing containing an inert polymer with 

a covalently bound enzyme through 

which nutritional formula is directed. 

The device fits in line with enteral 

feeding systems. 

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—ENZYME PACKED CARTRIDGE RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Adverse tissue reaction ............................................................................ Biocompatibility testing, Non-clinical testing, In vivo testing, and Labeling. 

Mechanical failure ..................................................................................... Non-clinical testing, Shelf life testing, and Labeling. 

• Deprivation of care.

• Device clogging.

• Filter becomes dislodged and releases beads into enteral formula.

Reduced enzymatic effect ........................................................................ Non-clinical testing, In vivo testing, Shelf life testing, and Labeling. 

Use error ................................................................................................... Human factors testing and Labeling. 

Infection .................................................................................................... Shelf life testing and 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. In order 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 


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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47971 

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). 

At the time of classification, enzyme 

packed cartridges are for prescription 

use only. Prescription devices are 

exempt from the requirement for 

adequate directions for use for the 

layperson 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 the conditions of 

21 CFR 801.109 are met. 

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 administrative order 

establishes special controls that refer to 

previously approved collections of 

information found in other FDA 

regulations. 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. 3501–3520). The 

collections of information in part 807, 

subpart E, regarding premarket 

notification submissions have been 

approved under OMB control number 

0910–0120, 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 876 

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 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 876.5985 to subpart F to read 

as follows: 

§ 876.5985 Enzyme packed cartridge. 

(a) Identification. An enzyme packed 

cartridge is an ex vivo prescription 

device that is used in enzymatic 

hydrolysis of macronutrients into their 

essential nutrient forms at the time of 

delivery. The device consists of an outer 

casing containing an inert polymer with 

a covalently bound enzyme through 

which nutritional formula is directed. 

The device fits in line with enteral 

feeding systems. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

(2) In vivo testing must be performed 

and must demonstrate that the device 

causes neither an adverse tissue 

response nor adverse performance. 

(3) Non-clinical testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use. The following performance 

characteristics must be demonstrated: 

(i) Mechanical testing to demonstrate 

that the device can withstand clinical 

forces; 

(ii) Flow rate and leakage testing to 

demonstrate that the device does not 

impede the flow of enteral formula; 

(iii) Demonstration of enzymatic effect 

on intended macronutrient; 

(iv) The amount of enzyme that exits 

the cartridge must be characterized; 

(v) Validation that the device does not 

adversely impact the nutritional 

composition of enteral formula; and 

(vi) Validation that the device does 

not impede flow alarms on enteral 

feeding pumps. 

(4) Human factors testing must be 

performed to characterize use error 

risks. 

(5) Performance data must support 

shelf life by demonstrating package 

integrity and device functionality over 

the identified shelf life. 

(6) Labeling must include the 

following: 

(i) A detailed summary of in vivo 

testing pertinent to use of the device, 

including device-related adverse events; 

(ii) A detailed summary of compatible 

formulas that is supported by nonclinical testing, including the expected 

enzymatic conversion as a percentage; 

(iii) Detailed instructions on how to 

place the device into an enteral feeding 

circuit; 

(iv) A warning regarding the 

possibility for misconnections; and 

(v) Expiration date or shelf life. 

(7) Patient labeling must be provided 

and must include: 

(i) Relevant warnings, precautions, 

adverse effects, and complications; 

(ii) A description of the device and 

how it operates; 

(iii) Instructions on how to correctly 

use the device; and 

(iv) The benefits and risks associated 

with the use of the device. 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22286 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–402] 

Schedules of Controlled Substances: 

Placement of AB-CHMINACA, ABPINACA and THJ-2201 Into Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places N-(1-amino-3- 

methyl-1-oxobutan-2-yl)-1- 

(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (AB-CHMINACA), N-(1- 

amino-3-methyl-1-oxobutan-2-yl)-1- 

pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ-2201), including 

their salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible, 

into schedule I of the Controlled 

Substances Act. This scheduling action 

is pursuant to the Controlled Substances 

Act which requires that such actions be 

made on the record after opportunity for 

a hearing through formal rulemaking. 

This rule continues the imposition of 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances on persons who 

handle (manufacture, distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis, or possess), or propose to 

handle AB-CHMINACA, AB-PINACA 

and THJ-2201. 

DATES: Effective October 16, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Lewis, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Under the Controlled Substances Act 

(CSA), each controlled substance is 

classified into one of five schedules 

based upon its potential for abuse, its 


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