Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Proposed Rules 41023 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 876, 878, and 886 

[Docket No. FDA–2018–N–3066] 

Medical Devices; Classification of 

Accessories Distinct From Other 

Devices; Proposed List of Accessories 

Suitable for Class I; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; request for 

comments. 

SUMMARY: As required by the FDA 

Reauthorization Act of 2017 (FDARA), 

the Food and Drug Administration (FDA 

or Agency) has identified a list of 

accessories for which the Agency 

believes general controls alone are 

sufficient to provide reasonable 

assurance of safety and effectiveness, so 

the accessories could be in class I. FDA 

is publishing this document proposing 

to classify these accessories into class I 

and distinct from other devices, as well 

as seek public comment in accordance 

with procedures established by FDARA. 

This document does not represent 

FDA’s final determination with respect 

to the proposed accessories listed in this 

document. 

DATES: Submit either electronic or 

written comments on the document by 

October 16, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 16, 

2018 The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 16, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3066 for ‘‘Medical Devices; 

Classification of Accessories Distinct 

from Other Devices; Proposed List of 

Accessories Suitable for Class I; Request 

for Comments.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ian 

Ostermiller, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5454, Silver Spring, 

MD 20993–0002, 301–796–5678. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 18, 2017, FDARA was 

signed into law (Pub. L. 115–52). 

Section 707 of FDARA amended section 

513(f) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) and, among 

other amendments, created a process for 

FDA to propose a list of accessories 

suitable for distinct classification into 

class I (see section 513(f)(6)(D)(i) of the 

FD&C Act (21 U.S.C. 360c(f)(6)(D)(i))). 

Section 707 of FDARA mandated that 

FDA make the first such proposal 

within a year of enactment of FDARA, 

and FDA is publishing this document in 

accordance with this statutory mandate. 

Section 201(h) of the FD&C Act 

defines ‘‘device’’ to include, among 

other articles, an ‘‘accessory’’ (see 21 

U.S.C. 321(h)). As such, all articles that 

meet the definition of ‘‘device’’, 

including accessories, are regulated 

under the FD&C Act. Based on sections 

201(h) and 513(f)(6) of the FD&C Act, 

we have described our current thinking 

on which devices we would generally 

consider to be accessories in the 

guidance document, ‘‘Medical Device 

Accessories—Describing Accessories 

and Classification Pathways,’’ available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM429672 

(‘‘Accessories Guidance’’). That 


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41024 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Proposed Rules 

guidance defines an accessory as a 

‘‘finished device that is intended to 

support, supplement, and/or augment 

the performance of one or more parent 

devices.’’ 

Section 513 of the FD&C Act defines 

three classes of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three classes of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). Some accessories 

may be granted marketing authorization 

as part of a submission for another 

device with which they are intended to 

be used and in class II or III that, if 

considered distinctly from another 

device (such as the parent device), may 

be suitable for classification into class I 

if general controls alone are sufficient to 

provide a reasonable assurance of safety 

and effectiveness of the accessory. 

Section 513(h)(1) defines general 

controls as the controls authorized by or 

under sections 501, 502, 510, 516, 518, 

519, and 520 of the FD&C Act. These 

controls include, but are not limited to, 

provisions related to adulteration and 

misbranding, registration and listing, 

records and reports on devices, and 

good manufacturing practices. The 

regulations for good manufacturing 

practices are under 21 CFR part 820, the 

Quality System regulation. Subject to 

the exceptions identified in 

§ 820.30(a)(2) (21 CFR 820.30(a)(2)) for 

specific devices and those automated 

with computer software, design controls 

under § 820.30 do not generally apply to 

a class I device. 

This document represents FDA’s 

compliance with FDARA’s requirement 

to identify the first list of accessories 

suitable for distinct classification into 

class I. As required by FDARA, we are 

providing you with the opportunity to 

provide comment. Once the comment 

period ends, we will consider the 

comments and publish in the Federal 

Register a final action classifying such 

suitable accessories into class I. 

II. Factors for Consideration 

The classification of each accessory 

will be based on the risks of the 

accessory when used as intended and 

the level of regulatory controls 

necessary to provide a reasonable 

assurance of safety and effectiveness of 

the accessory, notwithstanding the 

classification of any other device with 

which such accessory is intended to be 

used (see section 513(f)(6)(A) of the 

FD&C Act). 

In general, we considered an 

accessory to be eligible for classification 

into class I distinct from another device 

if the accessory: (1) Is not for use in 

supporting or sustaining human life, or 

of substantial importance in preventing 

impairment to human health; (2) does 

not represent a potential unreasonable 

risk of illness or injury; and (3) general 

controls alone would be sufficient to 

provide a reasonable assurance of safety 

and effectiveness of the accessory. 

Note that by regulation, design 

controls apply to class I devices only if 

the devices are automated with 

computer software or are listed under 

§ 820.30(a)(2)(ii). Thus, if an accessory 

is not automated with computer 

software but would require design 

controls to provide reasonable assurance 

of safety and effectiveness, we did not 

consider it eligible for classification 

through the final action based on this 

document. 

You may wish to propose additional 

accessories as suitable for distinct 

classification into class I using the 

factors described above where the 

accessories are otherwise eligible for 

classification under section 

513(f)(6)(D)(i) of the FD&C Act. Should 

you wish to propose additional 

accessories, your comment should 

briefly explain why you think general 

controls alone will provide reasonable 

assurance of safety and effectiveness. 

Conversely, should you disagree with 

any of the proposed accessories for class 

I, your comments should briefly explain 

why additional regulatory controls, such 

as premarket review through a 510(k) 

submission or premarket approval 

(PMA), are necessary to provide 

reasonable assurance of safety and 

effectiveness. 

III. Policy Clarification for 

Classification of Certain Accessories 

Used in Orthopedic Surgery 

Certain manual orthopedic 

instruments that are for use with other 

devices in orthopedic surgery meet 

FDA’s definition of an accessory 

described in the Accessories Guidance. 

Accordingly, we are clarifying our 

intended regulatory approach for certain 

accessories used in orthopedic surgery 

to distinguish which accessories may be 

candidates for classification per section 

513(f)(6)(D)(i) of the FD&C Act. 

Instruments for use in orthopedic 

surgery vary widely from general 

manual surgical instruments used to 

manipulate tissue to more complex 

accessories specifically designed for use 

with a parent device/system. 

Orthopedic manual surgical instruments 

are classified in § 888.4540 (21 CFR 

888.4540), and many ‘‘general use’’ 

instruments fall within this 

classification. This regulation pertains 

to ‘‘nonpowered hand-held device[s] 

intended for medical purposes to 

manipulate tissue, or for use with other 

devices in orthopedic surgery.’’ These 

devices are class I, subject to general 

controls, and exempt from premarket 

notification procedures, subject to the 

limitations of exemptions in 21 CFR 

888.9. This classification was based 

upon recommendations provided to 

FDA by the Orthopedic Device 

Classification Panel (the Panel) in 

October 1977 regarding classification of 

medical devices in commercial 

distribution before May 28, 1976. The 

Panel identified the following risks to 

health for this device type: ‘‘Tissue 

damage and adverse tissue reaction: 

Inadequate mechanical properties, such 

as lack of material strength of the 

device, may result in device fracture 

and possible tissue damage and, if 

fragments of the fractured device remain 

in the tissue, an adverse tissue reaction 

may result’’ (47 FR 29052). 

FDA agreed that class I was 

appropriate because general controls 

alone were sufficient to mitigate the risk 

of tissue damage and adverse tissue 

reaction associated with inadequate 

mechanical properties and provide a 

reasonable assurance of the safety and 

effectiveness of these devices. Over 

time, manufacturers have developed 

and sought to market orthopedic 

instrumentation with designs unique to 

a device system, and these types of 

instruments may present new or 

different risks compared to inadequate 

mechanical properties. For example, 

certain device-specific instruments are 

accessories and require precise 

technical specifications or design 

characteristics to function as intended 

to support, supplement or augment the 

parent device, and if not designed 

appropriately, could cause implant 

malpositioning or migration. 

Accordingly, FDA considers design 

controls (see § 820.30) to be an 

important element in the regulation of 

device-specific accessories, among other 

regulatory controls, to ensure 

appropriate compatibility between the 

accessory and the parent device. In 

contrast, class I orthopedic manual 

surgical instruments do not require such 

controls. 

Instruments that are ‘‘devicespecific,’’ or designed for use with a 

specific parent device/system and thus 

are accessories, have historically been 

reviewed in the same premarket 

submission as the parent device. In an 

effort to ensure a common 

understanding as to which orthopedic 

accessories fall under the existing class 

I regulation (§ 888.4540), and which 

devices do not and, therefore, may be 

candidates for classification under 

section 513(f)(6)(D)(i) of the FD&C Act, 


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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Proposed Rules 41025 

we propose the following definition: A 

device-specific orthopedic instrument is 

considered to be an accessory designed 

specifically for appropriate implantation 

or placement of the parent device, based 

upon unique dimensions, geometry, 

and/or deployment. In these cases, 

design specifications are critical to the 

proper use of the accessory in 

supporting, supplementing, and/or 

augmenting the performance of the 

parent device and/or a specific system. 

This excludes general use orthopedic 

instruments that are provided as a part 

of a system. 

It is often necessary for orthopedic 

instruments to be described in a 

premarket submission (e.g., 510(k), 

PMA) to evaluate that the parent device 

functions as intended. Such orthopedic 

instruments may be appropriately 

classified in an existing class I 

regulation (§ 888.4540) if they do not 

meet the definition of a device-specific 

orthopedic accessory above and their 

risk profile and necessary regulatory 

controls are commensurate with that of 

orthopedic manual surgical instruments. 

If they do meet the definition of a 

device-specific orthopedic accessory 

above, then such orthopedic accessories 

may still be eligible for classification 

under section 513(f)(6)(D)(ii) of the 

FD&C Act. 

We welcome comments to help 

identify accessories in other product 

areas where the classification of the 

accessory relative to the parent device 

may be unclear and would benefit from 

this type of policy clarification. 

IV. Proposed List of Accessories That 

May Be Suitable for Distinct 

Classification Into Class I 

We are proposing the following 

accessories, which have been granted 

marketing authorization as part of a 

premarket submission (i.e., 510(k), De 

Novo classification request, or PMA) for 

another device with which they are 

intended to be used, as suitable for 

distinct classification into class I (see 

Table 1). When we publish the final list 

of accessories based on this list and the 

factors in section II, we will consider 

those accessories classified into class I, 

distinct from other devices, through 

such action. 

We would place each of these 

accessories in 21 CFR part 876, 878, or 

886, as appropriate. Each of these 

accessories would be class I, exempt 

from the premarket notification 

procedures in 21 CFR part 807, subject 

to the applicable limitations of 

exemption (i.e., 21 CFR 876.9, 878.9, or 

886.9). We intend to make conforming 

changes to existing classification 

regulations as appropriate. 

TABLE 1—PROPOSED ACCESSORIES FOR CLASSIFICATION INTO CLASS I AND DISTINCT FROM OTHER DEVICES

Current status of accessory 

Proposed device type identification Current classification regulation 

(21 CFR) 

Device type 

(existing product code) 

876.1075 ......................................... Gastroenterology-urology accessories to a biopsy instrument 

(FCG).

Accessories used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel 

adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas. 

876.3350 and 876.3630 .................. Penile implant surgical accessories (JCW and FHW).Manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder 

sizer, cylinder insertion tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, 

temporary tubing plug, and hemostat shod tubing. 

876.4620 ......................................... Ureteral stent accessories (FAD) .. Accessories that aid in the insertion of the ureteral stent that is 

placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener. 

876.5010 ......................................... Biliary stent, drain, and dilator accessories (FGE).Manual devices that aid in the introduction and connection of biliary 

stents, drains, or dilators. This generic type of device includes the 

guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube. 

876.5090 ......................................... Suprapubic catheter accessories 

(KOB).

Manual devices that are used to facilitate the placement of a 

suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath. 

876.5280 ......................................... Implanted mechanical/hydraulic 

urinary continence device surgical accessories (EZY).

Manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the 

measurement tool or tape, connector assembly tool, temporary tubing plug, incision closing tool, tubing passer, and hemostat shod 

tubing. 

878.5070 ......................................... Air-handling apparatus accessory 

(FYD).

Supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides 

an interface between the components of the device or can be used 

to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches. 

No corresponding CFR Section ...... Corneal inlay inserter handle 

(LQE).

Hand-held device intended to be used as an accessory to a corneal 

inlay inserter. The device extends the length of the inlay inserter to 

aid in delivering the inlay implant. 

V. Paperwork Reduction Act of 1995 

This document refers to previously 

approved collections of information. 

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 following FDA 


amozie on DSK3GDR082PROD with PROPOSALS1
41026 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Proposed Rules 

regulations and guidance have been approved by OMB as listed in the 

following table: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

‘‘De Novo Classification Process (Evaluation of Automatic 

Class III Designation)’’.

De Novo classification process .................................................. 0910–0844 

800, 801, and 809 ....................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

‘‘Medical Device Accessories—Describing Accessories and 

Classification Pathways for New Accessory Types’’.

Medical Device Accessories ...................................................... 0910–0823 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17731 Filed 8–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–131186–17] 

RIN 1545–BO05 

Proposed Removal of Temporary 

Regulations on a Partner’s Share of a 

Partnership Liability for Disguised Sale 

Purposes; Hearing Cancellation 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Cancellation of notice of public 

hearing on proposed rulemaking. 

SUMMARY: This document cancels a 

public hearing on proposed regulations 

concerning how partnership liabilities 

are allocated for disguised sale 

purposes. 

DATES: The public hearing, originally 

scheduled for August 21, 2018 at 10:00 

a.m. is cancelled. 

FOR FURTHER INFORMATION CONTACT: 

Regina Johnson of the Publications and 

Regulations Branch, Legal Processing 

Division, Associate Chief Counsel 

(Procedure and Administration) at (202) 

317–6901 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking and notice of 

public hearing that appeared in the 

Federal Register on Tuesday, June 19, 

2018 (83 FR 28397) announced that a 

public hearing was scheduled for 

August 21, 2018 at 10:00 a.m. in the IRS 

Auditorium, Internal Revenue Service 

Building, 1111 Constitution Avenue 

NW, Washington, DC. The subject of the 

public hearing is under section 707 of 

the Internal Revenue Code. 

The public comment period for these 

regulations expired on July 19, 2018. 

The notice of proposed rulemaking and 

notice of hearing instructed those 

interested in testifying at the public 

hearing to submit a request to speak and 

an outline of the topics to be discussed. 

The outline of topics to be discussed 

was due by August 3, 2018. As of 

August 3, 2018, no one has requested to 

speak. Therefore, the public hearing 

scheduled for August 21, 2018 at 10:00 

a.m. is cancelled. 

Martin V. Franks, 

Branch Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel (Procedure and 

Administration). 

[FR Doc. 2018–17792 Filed 8–16–18; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[Docket ID DOD–2016–HA–0112] 

RIN 0720–AB69 

TRICARE; Extended Care Health 

Option (ECHO) Respite Care 

AGENCY: Office of the Secretary, 

Department of Defense (DoD). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule requests 

public comment on a proposed revision 

to the TRICARE Extended Care Health 

Option (ECHO) respite care benefit. 

Under the current program, TRICARE 

beneficiaries enrolled in ECHO are 

eligible for 16 hours of respite care per 

month in any month during which the 

beneficiary receives another ECHO 

authorized benefit (other than the EHHC 

benefit). This proposed rule seeks to 

eliminate the concurrent ECHO benefit 

requirement and allow beneficiaries 

enrolled in ECHO to receive a maximum 

of 16 hours of respite care per month, 

regardless of whether another ECHO 

benefit is received in the same month. 

DATES: Written comments received at 

the address indicated below by October 

16, 2018 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number or 

Regulatory Information Number (RIN) 

and title, by either of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Department of Defense, Office 

of the Deputy Chief Management 

Officer, Directorate for Oversight and 

Compliance, 4800 Mark Center Drive, 

Mailbox #24, Alexandria, VA 22350– 

1700. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the internet at http://

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Trish Reilly, Defense Health Agency, 

TRICARE Clinical Policy Division, 

telephone (619) 236–5332. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Proposed Rule 

This proposed rule seeks to amend 

the TRICARE ECHO program regulation 

to expand beneficiary access to ECHO 

respite care services. This proposed 

rule, if implemented, would eliminate 

the concurrent ECHO benefit 

requirement and allow beneficiaries 

enrolled in ECHO to receive a maximum 

of 16 hours of respite care per month, 

regardless of whether another ECHO 

benefit is received in the same month. 

This regulation is proposed under the 

authority of 5 U.S.C. 301 which allows 


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