Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27895 

CFR 10.115)). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because this 

guidance sets out compliance policy 

that reduces burden and is consistent 

with the public health. Although this 

guidance document is immediately in 

effect, it remains subject to comment in 

accordance with FDA’s GGP regulation. 

Before 2016, FDA regulations did not 

define the term ‘‘dietary fiber’’ for 

purposes of the Nutrition Facts and 

Supplement Facts labels. In the Federal 

Register of May 27, 2016 (81 FR 33742), 

we published a final rule amending our 

Nutrition Facts and Supplement Facts 

Labels regulations (hereafter referred to 

as ‘‘the final rule’’). The final rule, 

among other things, defines dietary fiber 

as non-digestible soluble and insoluble 

carbohydrates (with 3 or more 

monomeric units), and lignin that are 

intrinsic and intact in plants; isolated or 

synthetic non-digestible carbohydrates 

(with 3 or more monomeric units) 

determined by FDA to have 

physiological effects that are beneficial 

to human health (§ 101.9(c)(6)(i) (21 

CFR 101.9(c)(6)(i))). The final rule also 

identifies seven isolated or synthetic 

non-digestible carbohydrates, each of 

which has a physiological effect that is 

beneficial to human health and that 

must be declared as dietary fiber on 

Nutrition and Supplement Facts labels 

when present in a food. 

Interested parties can ask us to list 

additional isolated or synthetic nondigestible carbohydrates in the 

definition of dietary fiber in 

§ 101.9(c)(6)(i). For example, a 

manufacturer can request FDA to 

include another added isolated or 

synthetic non-digestible carbohydrate in 

the listing of dietary fibers by 

submitting a citizen petition under 21 

CFR 10.30. FDA would review the 

scientific evidence to determine 

whether the evidence supports the nondigestible carbohydrate as having a 

physiological effect that is beneficial to 

human health. If so, FDA would 

propose a rule to include the nondigestible carbohydrate in the listing of 

dietary fibers. 

Based on our review of citizen 

petitions that FDA has received 

requesting that we identify additional 

isolated or synthetic non-digestible 

carbohydrates in the listing of dietary 

fibers, and comments that we have 

received on a draft guidance entitled 

‘‘Scientific Evaluation of the Evidence 

on the Beneficial Physiological Effects 

of Isolated or Synthetic Non-Digestible 

Carbohydrates Submitted as a Citizen 

Petition (21 CFR 10.30)’’ and an 

accompanying document titled 

‘‘Evaluation of the Beneficial 

Physiological Effects of Isolated or 

Synthetic Non-Digestible 

Carbohydrates,’’ the availability of 

which we announced in the Federal 

Register of November 23, 2016 (81 FR 

84516 and 81 FR 84595), in addition to 

our independent evaluation of the 

available scientific data, we intend to 

add certain isolated or synthetic nondigestible carbohydrates to the dietary 

fiber definition in § 101.9(c)(6)(i) 

through our regular rulemaking process. 

The eight non-digestible carbohydrates 

that we intend to add are: Mixed plant 

cell wall fibers; arabinoxylan; alginate, 

inulin and inulin-type fructans; high 

amylose starch (resistant starch 2); 

galactooligosaccharide; polydextrose; 

and resistant maltodextrin/dextrin. One 

category of non-digestible carbohydrate 

that we intend to add to § 101.9(c)(6)(i) 

through our regular rulemaking 

process—mixed plant cell wall fibers— 

encompasses a number of fiber 

ingredients, such as rice bran fibers, soy 

fibers, and sugar cane fibers. We have 

tentatively determined that each of 

these isolated or synthetic nondigestible carbohydrates has a 

physiological effect that is beneficial to 

human health. Several petitions are still 

pending with FDA and reviewing this 

information is a very high priority for 

FDA. Firms also can submit new citizen 

petitions, and we will review the 

petitions on a rolling basis. Firms whose 

non-digestible carbohydrates do not 

meet our regulatory definition of 

‘‘dietary fiber’’ and are not one of the 

eight non-digestible carbohydrates 

identified in the guidance can still use 

those non-digestible carbohydrates in 

foods. Although those non-digestible 

carbohydrates cannot be listed as 

dietary fiber in the Nutrition Facts label, 

they would still be declared as part of 

the amount of total carbohydrate and 

listed by name in the ingredients on the 

food package. In addition, based on our 

review of the scientific evidence, 

including evidence we received in a 

citizen petition, we intend to establish 

a caloric value for polydextrose at 1 

kcal/g in § 101.9(c)(1)(i)(C). 

Pending completion of the rulemaking 

process, we are announcing a policy for 

the eight identified isolated or synthetic 

non-digestible carbohydrates when one 

or more are present in food and declared 

in the amount of ‘‘dietary fiber’’ on 

Nutrition Facts and Supplement Facts 

labels and when the caloric value of 1 

kcal/g is used to determine the calorie 

contribution of polydextrose. Section 

101.9(g) requires manufacturers to make 

and keep records to verify the amount 

of non-digestible carbohydrates added 

to food that do not meet the definition 

of dietary fiber. Under our policy, when 

a mixture of dietary fiber and one or 

more of these eight added non-digestible 

carbohydrates (that are not currently 

listed as a ‘‘dietary fiber’’ in the 

definition in § 101.9(c)(6)(i)) are present 

in a food, we do not expect 

manufacturers to make and keep records 

in accordance with § 101.9(g)(10) and 

(11) to verify the declared amount of 

one or more of these eight added nondigestible carbohydrates in the label and 

labeling of food. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at either 

https://www.fda.gov/FoodGuidances or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12867 Filed 6–14–18; 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–2018–N–1894] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Fluid Jet System for Prostate Tissue 

Removal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the fluid jet system for 

prostate tissue removal 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 fluid jet 


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27896 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 

system for prostate tissue removal’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 June 15, 

2018. The classification was applicable 

on December 21, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Cades, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G246, Silver Spring, 

MD, 20993–0002, 240–402–3900, 

Jessica.Cades@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

fluid jet system for prostate tissue 

removal 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, 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 (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 (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 (21 U.S.C. 360c(f)(2)). 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 PMA 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 April 17, 2017, PROCEPT 

BioRobotics Inc. submitted a request for 

De Novo classification of the 

AQUABEAM System. 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 the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on December 21, 2017, 

FDA issued an order to the requester 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 876.4350. We 

have named the generic type of device 

fluid jet system for prostate tissue 

removal, and it is identified as a 

prescription device intended for the 

resection and removal of prostatic tissue 

for the treatment of benign prostatic 

hyperplasia. The device cuts tissue by 

using a pressurized jet of fluid delivered 

to the prostatic urethra. The device is 

able to image the treatment area, or pairs 

with an imaging modality, to monitor 

treatment progress. 

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—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Injury from device operation causing one or more of the following: Clinical performance testing, Animal testing, Labeling, and 

Training. 

• Bleeding 

• Bruising 

• Penile or pelvic pain 


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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27897 

TABLE 1—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES—Continued 

Identified risks Mitigation measures 

• Dysuria 

• Incontinence 

• Bladder or prostate capsule perforation 

• Sexual dysfunction, including ejaculatory and erectile dysfunction 

• Transurethral resection syndrome 

• Urethral damage causing false passage or stricture 

• Rectal incontinence/perforation 

• Embolism 

Adverse tissue reaction ............................................................................................. Biocompatibility evaluation. 

Infection ..................................................................................................................... Sterilization validation, Reprocessing validation, Shelf life 

testing, and Labeling. 

Failure to remove target tissue or removal of non-target tissue .............................. Clinical performance testing, Animal testing, Software 

verification, validation, and hazard analysis, Non-clinical 

performance testing, Labeling, and Training. 

Electrical shock or electromagnetic interference ...................................................... Electrical safety testing, Electromagnetic compatibility 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 

final order. The necessary special 

controls appear in the regulation 

codified by this order. We encourage 

sponsors to consult with us if they wish 

to use a non-animal testing method they 

believe is suitable, adequate, validated, 

and feasible. We will consider if such an 

alternative method could be assessed for 

equivalency to an animal test method. 

This device is subject to premarket 

notification requirements under section 

510(k) of the FD&C Act. 

At the time of classification, fluid jet 

systems for prostate tissue removal 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 and 21 CFR 

801.5, as long as the conditions of 21 

CFR 801.109 are met (referring to 21 

U.S.C. 352(f)(1)). 

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. 3501–3520). 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 

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 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 § 876.4350 to subpart E to read 

as follows: 

§ 876.4350 Fluid jet system for prostate 

tissue removal. 

(a) Identification. A fluid jet system 

for prostate tissue removal is a 

prescription device intended for the 

resection and removal of prostatic tissue 

for the treatment of benign prostatic 

hyperplasia. The device cuts tissue by 

using a pressurized jet of fluid delivered 

to the prostatic urethra. The device is 

able to image the treatment area, or pairs 

with an imaging modality, to monitor 

treatment progress. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

evaluate the following: 

(i) All adverse events associated with 

the device, and 

(ii) Improvement in lower urinary 

tract symptoms (LUTS). 

(2) Physician training must be 

provided that includes: 

(i) Information on key aspects and use 

of the device, and 

(ii) Information on how to override or 

stop resection. 

(3) Animal testing must demonstrate 

that the device resects targeted tissue in 

a controlled manner without injury to 

adjacent non-target tissues. 

(4) Non-clinical performance data 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Measurement of targeting accuracy 

and reproducibility of high velocity 

fluid jet, and 

(ii) High pressure fluid jet verification 

testing at target and non-target tissues. 

(5) Software verification, validation, 

and hazard analysis must be performed. 

(6) The patient-contacting elements of 

the device must be demonstrated to be 

biocompatible. 

(7) Performance data must 

demonstrate the electrical safety and 

electromagnetic compatibility of the 

device. 

(8) Performance data must 

demonstrate the sterility of the patientcontacting components of the device. 


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27898 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 

(9) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(10) Performance data must validate 

the instructions for reprocessing and 

reliability of reusable components. 

(11) Labeling must include the 

following: 

(i) A section that summarizes the 

clinical testing results, including the 

adverse event profile and improvement 

in LUTS; 

(ii) A shelf life for single use 

components; 

(iii) A use life for reusable 

components; and 

(iv) Reprocessing instructions for 

reusable components. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12829 Filed 6–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4022 and 4044 

Allocation of Assets in SingleEmployer Plans; Benefits Payable in 

Terminated Single-Employer Plans; 

Interest Assumptions for Valuing and 

Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Pension Benefit Guaranty Corporation’s 

regulations on Benefits Payable in 

Terminated Single-Employer Plans and 

Allocation of Assets in Single-Employer 

Plans to prescribe interest assumptions 

under the benefit payments regulation 

for valuation dates in July 2018 and 

interest assumptions under the asset 

allocation regulation for valuation dates 

in the third quarter of 2018. The interest 

assumptions are used for valuing and 

paying benefits under terminating 

single-employer plans covered by the 

pension insurance system administered 

by PBGC. 

DATES: Effective July 1, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Hilary Duke (duke.hilary@PBGC.gov), 

Assistant General Counsel for 

Regulatory Affairs, Pension Benefit 

Guaranty Corporation, 1200 K Street 

NW, Washington, DC 20005, 202–326– 

4400, ext. 3839. (TTY users may call the 

Federal relay service toll free at 1–800– 

877–8339 and ask to be connected to 

202–326–4400, ext. 3839.) 

SUPPLEMENTARY INFORMATION: PBGC’s 

regulations on Allocation of Assets in 

Single-Employer Plans (29 CFR part 

4044) and Benefits Payable in 

Terminated Single-Employer Plans (29 

CFR part 4022) prescribe actuarial 

assumptions—including interest 

assumptions—for valuing and paying 

plan benefits under terminating singleemployer plans covered by title IV of 

the Employee Retirement Income 

Security Act of 1974 (ERISA). The 

interest assumptions in the regulations 

are also published on PBGC’s website 

(http://www.pbgc.gov). 

The interest assumptions in appendix 

B to part 4044 are used to value benefits 

for allocation purposes under ERISA 

section 4044. PBGC uses the interest 

assumptions in appendix B to part 4022 

to determine whether a benefit is 

payable as a lump sum and to determine 

the amount to pay. Appendix C to part 

4022 contains interest assumptions for 

private-sector pension practitioners to 

refer to if they wish to use lump-sum 

interest rates determined using PBGC’s 

historical methodology. Currently, the 

rates in appendices B and C of the 

benefit payment regulation are the same. 

The interest assumptions are intended 

to reflect current conditions in the 

financial and annuity markets. 

Assumptions under the asset allocation 

regulation are updated quarterly; 

assumptions under the benefit payments 

regulation are updated monthly. This 

final rule updates the benefit payments 

interest assumptions for July 2018 and 

updates the asset allocation interest 

assumptions for the third quarter (July 

through September) of 2018. 

The third quarter 2018 interest 

assumptions under the allocation 

regulation will be 2.53 percent for the 

first 25 years following the valuation 

date and 2.64 percent thereafter. In 

comparison with the interest 

assumptions in effect for the second 

quarter of 2018, these interest 

assumptions represent an increase of 5 

years in the select period (the period 

during which the select rate (the initial 

rate) applies), an increase of 0.26 

percent in the select rate, and an 

increase of 0.05 percent in the ultimate 

rate (the final rate). 

The July 2018 interest assumptions 

under the benefit payments regulation 

will be 1.25 percent for the period 

during which a benefit is in pay status 

and 4.00 percent during any years 

preceding the benefit’s placement in pay 

status. In comparison with the interest 

assumptions in effect for June 2018, 

these interest assumptions represent no 

change in the immediate rate and no 

changes in i1, i2, or i3. 

PBGC has determined that notice and 

public comment on this amendment are 

impracticable and contrary to the public 

interest. This finding is based on the 

need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the valuation 

and payment of benefits under plans 

with valuation dates during July 2018, 

PBGC finds that good cause exists for 

making the assumptions set forth in this 

amendment effective less than 30 days 

after publication. 

PBGC has determined that this action 

is not a ‘‘significant regulatory action’’ 

under the criteria set forth in Executive 

Order 12866. 

Because no general notice of proposed 

rulemaking is required for this 

amendment, the Regulatory Flexibility 

Act of 1980 does not apply. See 5 U.S.C. 

601(2). 

List of Subjects 

29 CFR Part 4022 

Employee benefit plans, Pension 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 4044 

Employee benefit plans, Pension 

insurance, Pensions. 

In consideration of the foregoing, 29 

CFR parts 4022 and 4044 are amended 

as follows: 

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE–EMPLOYER 

PLANS 

■ 1. The authority citation for part 4022 

continues to read as follows: 

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344. 

■ 2. In appendix B to part 4022, Rate Set 

297 is added at the end of the table to 

read as follows: 

Appendix B to Part 4022—Lump Sum 

Interest Rates for PBGC Payments 

* * * * * 


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