[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Proposed Rules]
[Pages 41023-41026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17731]



[[Page 41023]]

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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.

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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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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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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 Sec.  820.30(a)(2) (21 CFR 820.30(a)(2)) for 
specific devices and those automated with computer software, design 
controls under Sec.  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 Sec.  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 Sec.  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 Sec.  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 ``device-specific,'' 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 
(Sec.  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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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 (Sec.  
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
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           Current status of accessory
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                                   Device type      Proposed device type
    Current classification      (existing product      identification
      regulation (21 CFR)             code)
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876.1075......................  Gastroenterology-  Accessories used to
                                 urology            remove a specimen of
                                 accessories to a   tissue for
                                 biopsy             microscopic
                                 instrument (FCG).  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     Manual devices
                                 surgical           designed to be used
                                 accessories (JCW   for surgical
                                 and FHW).          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 that aid
                                 accessories        in the insertion of
                                 (FAD).             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,     Manual devices that
                                 drain, and         aid in the
                                 dilator            introduction and
                                 accessories        connection of
                                 (FGE).             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         Manual devices that
                                 catheter           are used to
                                 accessories        facilitate the
                                 (KOB).             placement of a
                                                    suprapubic catheter.
                                                    This generic type of
                                                    device includes the
                                                    introducer, access
                                                    dilator, and peel-
                                                    away sheath.
876.5280......................  Implanted          Manual devices
                                 mechanical/        designed to be used
                                 hydraulic          for surgical
                                 urinary            procedures
                                 continence         associated with the
                                 device surgical    implantation of an
                                 accessories        implanted mechanical/
                                 (EZY).             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       Supplementary device
                                 apparatus          that is intended to
                                 accessory (FYD).   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      Hand-held device
                                 inserter handle    intended to be used
                                 (LQE).             as an accessory to a
                                                    corneal inlay
                                                    inserter. The device
                                                    extends the length
                                                    of the inlay
                                                    inserter to aid in
                                                    delivering the inlay
                                                    implant.
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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

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

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
``Medical Device Accessories--   Medical Device                0910-0823
 Describing Accessories and       Accessories.
 Classification Pathways for
 New Accessory Types''.
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    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