[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Rules and Regulations]
[Pages 14865-14870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07290]



[[Page 14865]]

-----------------------------------------------------------------------

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; Finalized List of Accessories Suitable for Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Final classification action.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
classifying suitable accessories into class I as required by the FDA 
Reauthorization Act of 2017 (FDARA). The Agency has determined that 
general controls alone are sufficient to provide reasonable assurance 
of safety and effectiveness for these accessories. We made this 
determination based on the risks of the accessories when used as 
intended with other devices such as the parent or system.

DATES: This final classification action is effective May 13, 2019.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final 
classification action 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) (21 U.S.C. 360c(f)) and, among other 
amendments, created a process for FDA to propose a list of accessories 
suitable for distinct classification into class I. Section 
513(f)(6)(D)(i) of the FD&C Act mandated that FDA make the first such 
proposal within a year of enactment of FDARA, and FDA published that 
proposal in the Federal Register of August 17, 2018 (83 FR 41023). 
Section 513(f)(6)(D)(i) also requires that FDA publish a final action 
classifying suitable accessories into class I within 180 days after the 
end of the comment period. This final classification action fulfills 
that requirement.
    In the proposal, we explained that the classification of each 
accessory is 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) (21 CFR 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 this classification 
process.
    In this final classification action, we are classifying into class 
I all of the accessories that we proposed as suitable for distinct 
classification in class I. We are not including additional accessories 
in this final classification action, but FDA intends to publish another 
proposed list of accessories that may be suitable for distinct 
classification into class I in accordance with the statutory deadline 
of 5 years from the first such proposal (see 21 U.S.C. 
360c(f)(6)(D)(i)).

II. Comments on the Proposal

    FDA received comments from industry, trade associations, and 
individuals on FDA's proposal. Various comments were regarding topics 
that were determined to be outside the scope of this final 
classification action. We have considered the remaining comments and 
respond briefly to them as follows. The order of response to the 
commenters is purely for organizational purposes and does not signify 
the comment's value or importance nor the order in which comments were 
received. Certain comments are grouped together under a single number 
because the subject matter is similar. In several comments, commenters 
requested ``guidance'' on various topics, which we have interpreted to 
mean additional information rather than FDA guidance within the meaning 
of 21 CFR 10.115(b).
    (Comment 1) One commenter stated that class I devices should 
include a disclaimer that serious harm may result from their improper 
use or installation. The commenter believes this will provide an 
incentive for patients to ask their doctors about the proper use of 
devices because patients may not see device labeling.
    (Response) Class I devices are subject to general controls, which 
are defined in section 513(h)(1) of the FD&C Act. These general 
controls include, but are not limited to, certain labeling requirements 
under the FD&C Act and part 801 (21 CFR part 801), among other 
provisions. Changes to labeling requirements under the FD&C Act and 
part 801 are outside the scope of this final classification action.
    (Comment 2) Several commenters suggested that additional product 
codes be considered for distinct classification into class I. One of 
these commenters believes that many of the accessories listed in the 
comment were considered by FDA to have a higher classification solely 
due to the risk of the parent device and FDA's previous review 
practices. That commenter believes some of these accessories fall under 
existing class I classification regulations and should be placed into 
class I through this final classification action.
    (Response) We have reviewed all product codes suggested for 
distinct classification into class I in response to comments and have 
determined that additional product codes identified are not appropriate 
for this list at the present time for one or more of the following 
reasons: (1) The accessory type is already distinctly classified; (2) 
the accessory is of a type that is already class I; or (3) insufficient 
information was provided to demonstrate that general controls alone 
will provide reasonable assurance of safety and effectiveness.
    FDA will consider additional product codes for distinct 
classification into class I as part of a future proposal in accordance 
with the statutory deadline of 5 years from the first such proposal 
under section 513(f)(6)(D)(i) of the FD&C Act. If a manufacturer or 
importer with marketing authorization for an accessory believes its 
accessories are suitable for distinct classification, the manufacturer 
or importer can also request a class I designation through an existing 
accessory request pursuant to section 513(f)(6)(D)(ii) of the FD&C Act.
    (Comment 3) One commenter requested clarification on two of FDA's

[[Page 14866]]

proposed regulations for penile implant surgical accessories and 
implanted mechanical/hydraulic urinary continence device surgical 
accessories. This includes the identification of product code FAE for 
penile implant surgical accessories, and specific edits to the list of 
accessories included in FDA's proposal.
    (Response) FDA agrees with the commenter. The identified 
accessories intended for use with a penile prosthesis under product 
codes FAE and FTQ were within FDA's intent, but the proposal did not 
make that clear. FDA has also clarified that penile implant surgical 
accessories suitable for class I include the cylinder insertion needle, 
device placement tool, tubing plug, and blunt needle. Additionally, 
implanted mechanical/hydraulic urinary continence device surgical 
accessories suitable for class I include the tubing plug and blunt 
needle. For both types of accessories, FDA has found that general 
controls alone provide a reasonable assurance of safety and 
effectiveness.
    (Comment 4) Two commenters noted that section III of the proposal 
``Policy Clarification for Classification of Certain Accessories Used 
in Orthopedic Surgery'' was inconsistent with the risk-based approach 
to classification of accessories as outlined in FDARA, and 
classification should not be based upon whether or not an instrument is 
considered ``general use'' or ``device-specific''. These commenters 
also requested that FDA either revert back to ``previous longstanding 
practice and treat all manual surgical instruments provided with Class 
II or Class III orthopedic implant systems as Class I (510(k)/PMA 
[premarket approval application] exempt) devices, in accordance with 
their current classification designation'' or publish new 
classifications for instruments that carry a higher risk. One commenter 
further noted administrative challenges (e.g., tracking recalls, unique 
device identifier markings) for those instruments that have taken on 
the classification of the parent device and do not carry their own 
product code or regulation.
    (Response) This policy clarification does not impose new regulatory 
requirements upon devices that had previously been cleared or approved, 
but rather provides transparency for the Agency's existing policy 
concerning classification of certain orthopedic accessories. We agree 
that the classification of existing accessories should and must be 
based upon the risk 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 the parent device, and that the provisions in 
section 513(f)(6) of the FD&C Act may be appropriate to distinctly 
classify certain orthopedic accessory types. By clarifying how we have 
regulated different types of instruments for orthopedic surgery, we 
aimed to explain the limited scope of accessories that would be 
appropriate for distinct classification through mechanisms outlined in 
section 513(f)(6) of the FD&C Act and provide clarity regarding 
accessories that fit within existing class I classification 
regulations. If an accessory is distinctly classified, a separate 
classification regulation will be created. We believe this will support 
separate identification of the accessory distinct from the parent 
device.
    After reviewing the comments, we continue to believe that the 
existing policy concerning classification of certain accessories used 
in orthopedic surgery should not be changed. Namely, such accessories 
are appropriately classified as orthopedic manual surgical instruments 
(Sec.  888.4540 (21 CFR 888.4540)) provided they do not meet the 
definition of a device-specific orthopedic accessory as outlined in 
FDA's proposal and their risk profile and regulatory controls are 
commensurate with that of orthopedic manual surgical instruments. 
Further, we continue to believe that certain device-specific orthopedic 
instruments have new or different risks to health compared to 
orthopedic manual surgical instruments, and general controls alone will 
not provide reasonable assurance of safety and effectiveness. These 
``device-specific'' accessories are specifically designed for 
appropriate implantation or placement of the parent device and have 
unique dimensions, geometry, or deployment mechanisms. These 
accessories are critical for precise and proper placement of the parent 
device, and therefore, FDA considers design controls to be an important 
element in the regulation of such accessories to ensure appropriate 
compatibility between the accessory and the parent device (see Sec.  
820.30).
    (Comment 5) Two commenters noted that additional guidance should be 
provided for manufacturers who wish to seek distinct classification of 
orthopedic accessories, namely ``considerations for reclassification of 
instruments that have been previously classified through a premarket 
submission based on their association with a particular implant 
system'' and ``the specific information that FDA would expect to see in 
the requests for instrument reclassification, preferably in a 
standardized submission format.''
    (Response) Although the question pertains to a different provision 
than this final classification action, we believe that clarification in 
this case may assist manufacturers and FDA staff for future accessory 
classification actions. Any manufacturer or importer may submit a 
request for appropriate classification of an existing accessory per 
section 513(f)(6)(D)(ii) of the FD&C Act. According to FDA's guidance 
``Medical Device Accessories: Describing Accessories and Classification 
Pathways'' (available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429672.pdf), such a 
request should include ``[t]he proposed classification of the accessory 
(i.e., class I or class II), as well as the current classification, 
should also be clearly identified in the cover letter and/or the 
request. An Existing Accessory Request should include the necessary 
information, based on Least Burdensome principles, to establish the 
risk profile of the accessory when used as intended with the identified 
parent device. . . . Note that requests for classification of an 
accessory in class II must include an initial draft proposal for 
special controls, if special controls would be required pursuant to 
subsection 513(a)(1)(B) of the FD&C Act.'' Additional information 
regarding reclassification processes are described in sections 513(e) 
and (f)(3) of the FD&C Act. FDA recommends manufacturers submit a Pre-
Submission if they have specific questions regarding such a request. 
More information regarding the Pre-Submission Program can be found in 
FDA's guidance entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' (available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf).
    (Comment 6) One commenter included several comments regarding the 
definition of ``device-specific instrument'' that we provided in 
section III of the proposal (the ``Policy Clarification for 
Classification of Certain Accessories Used in Orthopedic Surgery''). 
The commenter noted the definition was vague and sought clarity on what 
is meant by ``unique dimensions, geometry, and/or deployment.''
    (Response) To provide further clarity regarding how we interpret 
``unique dimensions, geometry, and/or

[[Page 14867]]

deployment'' in the definition for device-specific orthopedic 
instrument outlined in FDA's proposal, we provide the following 
examples to illustrate the types of instruments that we would consider 
to be ``device-specific'' and types that are not:
    Examples of instruments that would be considered ``device-
specific'':
    (1) A screwdriver that mates through a unique geometry or 
connection to a specially designed screw, which could not be inserted 
by a standard, generally available screwdriver. Such an instrument 
would possess a unique geometry that could not be utilized with screws 
of industry standard dimensions (such as cortical (HA) and cancellous 
(HB) bone screws per ASTM F543 \1\). In contrast, a general use 
screwdriver could be used across screws ``from multiple 
manufacturers''.
---------------------------------------------------------------------------

    \1\ ASTM F543, Standard Specification and Test Methods for 
Metallic Medical Bone Screws. For the current edition of the FDA 
recognized standard referenced in this document, see the FDA 
Recognized Consensus Standards Database, available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
---------------------------------------------------------------------------

    (2) An inserter instrument that is designed to specifically 
interface with features of the parent device to allow for insertion of 
the device. Such an instrument would possess unique dimensions or 
geometry to mate specifically with the parent device. In contrast, 
impactors are used to place an implant and do not require a specific 
interface with the parent device. These are general use instruments 
that could be used across multiple device types and are not based on 
unique dimensions, geometry, or deployment of a parent device.
    Examples of instruments that would not be considered ``device-
specific'':
    (1) Bone taps solely to create a preliminary hole to help guide 
subsequent placement of a screw and can be used across multiple screw 
types/sizes. These are not based upon unique dimensions, geometry, or 
deployment of a parent device.
    (2) Reamers are not based upon unique dimensions, geometry, or 
deployment of a parent device and can be used across multiple device 
types to prepare a site for implantation.
    In all such examples, a general use version of the instrument may 
still be designed based upon certain dimensions of the parent device 
(e.g., according to industry standard screw dimensions). However, 
device-specific instruments are designed specifically for use with a 
particular parent device based upon ``unique dimensions, geometry, or 
deployment'' of the parent device (e.g., sizes that would not be 
compatible with industry standard dimensions, or specific features that 
are only present on the parent device).
    (Comment 7) One commenter proposed an alternative definition for 
``device-specific instrument'' as follows: ``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 when 
the instrument has an intended use or fundamental scientific technology 
that differs from those of the generic types of instruments either 
listed in the regulation or previously accepted as being contained 
within the regulation.''
    The commenter notes that these revisions are necessary to avoid the 
definition applying to instruments that clearly fall within an existing 
class I classification regulation (e.g., Sec.  888.4540), citing a 
screwdriver as being an example of such an instrument that could be 
interpreted, based upon the definition, to be ``device-specific.''
    (Response) FDA does not agree with the proposed additional text 
(i.e., ``. . . when the instrument has an intended use or fundamental 
scientific technology that differs from those of the generic types of 
instruments either listed in the regulation or previously accepted as 
being contained within the regulation''). This text suggests that such 
instruments could fit under existing class I regulations (i.e., would 
exceed the limitation of exemption under 21 CFR 888.9(a) and (b)) but 
would subsequently be appropriately regulated under such regulation 
following submission of a 510(k)). However, this does not address the 
Agency's position that general controls alone are insufficient to 
mitigate risks to health. Furthermore, the phrase ``previously accepted 
as being contained within the regulation'' is unclear.
    We also disagree with the commenter's statement that the definition 
as written would result in such a screwdriver being deemed device-
specific, as such an instrument would not be ``based upon unique 
dimensions, geometry, and/or deployment'' of the parent device, unless 
the parent device (screw) was somehow unique in design (e.g., a screw 
head which would not fit a standard screwdriver).
    (Comment 8) One commenter posed several specific scenarios to 
better understand circumstances under which an accessory would be 
deemed ``device-specific,'' such as whether branding makes an accessory 
device-specific, whether an accessory remains ``device-specific'' if 
used with another device made by a manufacturer, or whether accessories 
to be used ``across systems'' applies to systems from the same 
manufacturer. Similarly, they asked if a combination of two general 
accessories from two different systems could still be considered a 
general use accessory.
    (Response) In response to the comments, we are clarifying that the 
sole presence of a branding statement would not render an accessory 
``device-specific'' according to this definition. An accessory for use 
with other devices made by a manufacturer may or may not be determined 
to be ``device-specific,'' depending on the design of the accessory. 
For example, an accessory designed for use for a specific system, i.e., 
across multiple-device sizes within the same family of devices, would 
be device-specific if it is designed specifically for appropriate 
implantation or placement of the parent device, based upon unique 
dimensions, geometry, and/or deployment.
    In some cases, an accessory may also be designed for use across 
multiple systems from the same manufacturer. Accessories that can be 
used across systems from the same manufacturer may or may not be 
considered device-specific, depending on technology, design, and 
configuration. For example, one manufacturer may have several systems 
of intervertebral body fusion devices, with inserter instruments that 
are specifically designed to mate with a unique feature on all devices 
in the systems and would therefore be considered device-specific. Such 
an instrument would possess unique dimensions or geometry to mate 
specifically with the parent device.
    In contrast, the combination of two general use accessories would 
result in a general use accessory. This is because neither accessory 
has a design, geometry, and/or deployment suited to a particular device 
or device family.
    (Comment 9) One commenter sought clarity on how the device-specific 
definition should be applied retroactively to previously cleared/
approved orthopedic accessories.
    (Response) The definition of ``device-specific'' was intended to 
clarify existing policy regarding regulation of orthopedic accessories, 
not to establish new policy. If a device was cleared within a 510(k) as 
an accessory but appropriately fits into an existing class I 
classification regulation based on the policy clarification, this 
determination can be documented to file by the manufacturer along with 
updating the listing accordingly.
    (Comment 10) One commenter provided several comments regarding

[[Page 14868]]

sizing templates, noting that they would meet the definition of 
``device-specific'' but are otherwise distinctly classified in a class 
I classification regulation (Sec.  888.4800 (21 CFR 888.4800)). This 
commenter also included several examples of other devices (e.g., 
sizers, cutting guides, and trials) that would fall under this 
classification regulation.
    (Response) In recent history, Sec.  888.4800 has been interpreted 
to apply to imaging templates used to estimate proper device size prior 
to surgery rather than physical trials/sizers to be used in a surgical 
procedure. The initial classification panel identified the following 
risks to health associated with devices under this classification 
regulation: Tissue damage and adverse tissue reaction. Fracture of the 
device could injure surrounding tissue and, if device fragments remain 
in the tissue, could cause an adverse tissue reaction.
    Further review in response to this comment has led FDA to 
reconsider the instruments that were to be subject to this 
classification regulation. We agree that trials or templates that are 
basic sizing devices for proper implant selection may be appropriately 
regulated under Sec.  888.4800, despite the recent practice of 
regulating these trials with the parent device.
    The Agency does not, however, consider cutting guides to fall 
within this classification regulation, as Sec.  888.4800 specifically 
calls out devices that are used for ``guiding the marking of tissue 
before cutting'' but does not expressly include a physical guide to 
direct the orientation of a cut. These devices carry a higher risk than 
devices simply intended to mark tissues, as in addition to the risk 
associated with this classification regulation (i.e., tissue damage and 
adverse tissue reaction), an improper physical cut in the tissue leads 
to improper placement of the parent device and potential for resulting 
device malfunction or failure.
    (Comment 11) One commenter sought clarity on the application of 
design controls to class I instruments that interface with higher-
classification parent devices. The commenter notes that ``any interface 
with a mating instrument (regardless of instrument classification) 
would be subject to design controls via requirements for the parent 
device.''
    (Response) As FDA stated in the proposal, 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).
    (Comment 12) One commenter sought clarity as to whether a risk-
based justification could be utilized in determining if a device is an 
accessory to a parent device. While an instrument may have device-
specific features, the risk may be commensurate with that of orthopedic 
manual surgical instruments.
    (Response) The determination of whether a device meets the 
definition of an accessory is not a risk-based decision. We have 
outlined in FDA's proposal why we consider devices with features 
specific to a parent device to pose additional risk beyond those of 
general use orthopedic manual surgical instruments.
    (Comment 13) One commenter stated that the definition of ``device-
specific'' instrument is not consistent with FDA's definition of an 
accessory as outlined in the guidance document entitled ``Medical 
Device Accessories: Describing Accessories and Classification 
Pathways.''
    (Response) We do not consider the proposed definition for device-
specific instrument to be inconsistent with FDA's definition of an 
accessory, as device-specific orthopedic instruments are those designed 
specifically for appropriate implantation or placement of the parent 
device, based upon unique dimensions, geometry, and/or deployment. 
Furthermore, the device-specific orthopedic instrument definition is 
derived from the definition of accessories (i.e., in that ``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.'').
    (Comment 14) One commenter notes that FDA stated in its proposal 
that ``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 
they are not designed appropriately could cause implant malpositioning 
or migration,'' and, thus, ``are ineligible for reclassification in 
class I.'' The commenter sought clarity as to why other class I exempt 
devices would not also ``require precise technical specifications or 
design characteristics.''
    (Response) We expect that any device would have certain technical 
specifications or design characteristics that dictate their 
manufacture. However, for some devices, including device-specific 
orthopedic instruments, the safety, performance, and dependability of 
the device are critical for precise and proper placement of the parent 
device. Design controls, among other benefits, increase the likelihood 
that the design transferred to production will translate into a device 
that is appropriate for its intended use, including precise and proper 
placement of the parent.\2\ Therefore, device-specific orthopedic 
instruments require the application of design controls for reasonable 
assurance of safety and effectiveness.
---------------------------------------------------------------------------

    \2\ For more information about design controls, refer to FDA's 
guidance document entitled ``Design Control Guidance for Medical 
Device Manufacturers,'' available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf.
---------------------------------------------------------------------------

    (Comment 15) One commenter asked for examples of what ``other 
regulatory controls'' beyond design controls may be necessary to ensure 
compatibility, as stated in the proposal.
    (Response) Another regulatory control could be, for example, 
premarket notification. For these devices for which verification of 
compatibility would be necessary, this may be evaluated through 
information (e.g., device description, performance testing) provided in 
a premarket submission.
    (Comment 16) One commenter sought guidance on the type of 
information needed to describe a device-specific orthopedic instrument 
in premarket submissions, as well as guidance for manufacturers whose 
accessories have been reclassified under section 513(f)(6)(D)(ii) of 
the FD&C Act. This commenter also suggested that FDA consider 
classification of the orthopedic instruments as class I with design 
controls.
    (Response) The commenter's requests are outside the scope of this 
final classification action.
    (Comment 17) One commenter noted that one of the proposed 
accessories for classification into class I is a handle to an inserter 
device for a class III product. They sought further clarity to 
determine whether handles for modular orthopedic instruments could be 
distinctly classified from their working end.
    (Response) The referenced corneal inlay implant device is class 
III, and we proposed distinct classification of the associated handles 
into class I. Similarly, other such instrument handles associated with 
orthopedic devices cleared through 510(k) or PMA could be distinctly 
classified from the parent device using mechanisms outlined in section 
513(f)(6)(D)(ii) of the FD&C Act.
    (Comment 18) One commenter noted that some instruments provided in 
sets used during a surgery may not be considered ``accessories'' but 
are provided within these sets for ease of processing and access for 
the surgeon. Furthermore, some of these instruments may fall under 
existing class I classification regulations.

[[Page 14869]]

    (Response) We agree with the commenter. Many instruments in 
instrument sets would not be considered accessories to the device, and 
some accessories may already be distinctly classified in existing class 
I classification regulations.

III. Policy Clarification for Classification of Certain Accessories 
Used in Orthopedic Surgery

    In the proposal, FDA provided a policy clarification for the 
regulatory approach for certain accessories used in orthopedic surgery 
to distinguish which accessories may be candidates for classification 
under section 513(f)(6)(D)(i) of the FD&C Act. This policy 
clarification acknowledged that instruments used in orthopedic surgery 
span a wide range of complexity, with many ``general use'' instruments 
falling within existing class I classification regulations (e.g., Sec.  
888.4540), while other ``device-specific'' instruments 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 are considered ``device-specific,'' thereby not 
falling within an existing class I classification regulation, and which 
may be candidates for classification under section 513(f)(6)(D)(i) of 
the FD&C Act, we provided 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. 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. This excludes general use orthopedic 
instruments that are provided as a part of a system.
    Based upon comments in response to this section of the proposal, 
FDA has not altered the policy clarification or definition of device-
specific orthopedic instruments as previously described but has 
provided additional clarification and examples in the responses 
discussed in section II above. FDA intends to engage with industry 
stakeholders on the topic to resolve additional questions regarding the 
existing policy or future proposals for distinct classification of 
accessories under section 513(f)(6)(D)(ii) of the FD&C Act.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this final 
classification 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.

V. Paperwork Reduction Act of 1995

    This final classification action 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 regulations and 
guidance have been approved by OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                                                                                                   OMB  control
            21 CFR part; guidance; or FDA form                             Topic                        No.
----------------------------------------------------------------------------------------------------------------
807, subpart E...........................................  Premarket notification...............       0910-0120
814, subparts A through E................................  Premarket approval...................       0910-0231
``De Novo Classification Process (Evaluation of Automatic  De Novo classification process.......       0910-0844
 Class III Designation)''.
800, 801, and 809........................................  Medical Device Labeling Regulations..       0910-0485
820......................................................  Current Good Manufacturing Practice         0910-0073
                                                            (CGMP); Quality System (QS)
                                                            Regulation.
``Medical Device Accessories: Describing Accessories and   Medical Device Accessories...........       0910-0823
 Classification Pathways for New Accessory Types.''.
``Requests for Feedback on Medical Device Submissions:     Q-submissions........................       0910-0756
 The Pre-Submission Program and Meetings with Food and
 Drug Administration Staff''.
----------------------------------------------------------------------------------------------------------------

List of Subjects

21 CFR Part 876

    Medical devices.

21 CFR Part 878

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
876, 878, and 886 are amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.1080 to subpart B to read as follows:


Sec.  876.1080   Gastroenterology-urology accessories to a biopsy 
instrument.

    (a) Identification. A gastroenterology-urology accessory to a 
biopsy instrument is an accessory 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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
3. Add Sec.  876.3500 to subpart D to read as follows:


Sec.  876.3500   Penile implant surgical accessories.

    (a) Identification. Penile implant surgical accessories are 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

[[Page 14870]]

and needle, device placement tool, connector assembly tool, incision 
closing tool, corporeal dilator, tubing passer, measurement tool or 
tape, tubing plug, blunt needle, and hemostat shod tubing.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
4. Add Sec.  876.4630 to subpart E to read as follows:


Sec.  876.4630  Ureteral stent accessories.

    (a) Identification. Ureteral stent accessories 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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
5. Add Sec.  876.5012 to subpart F to read as follows:


Sec.  876.5012  Biliary stent, drain, and dilator accessories.

    (a) Identification. Biliary stent, drain, and dilator accessories 
are 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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
6. Add Sec.  876.5100 to subpart F to read as follows:


Sec.  876.5100  Suprapubic catheter accessories.

    (a) Identification. Suprapubic catheter accessories are 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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

0
7. Add Sec.  876.5290 to subpart F to read as follows:


Sec.  876.5290   Implanted mechanical/hydraulic urinary continence 
device surgical accessories.

    (a) Identification. Implanted mechanical/hydraulic urinary 
continence device surgical accessories are 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, tubing plug, incision closing tool, tubing passer, blunt 
needle, and hemostat shod tubing.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
8. The authority citation for part 878 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
9. Add Sec.  878.5080 to subpart F to read as follows:


Sec.  878.5080   Air-handling apparatus accessory.

    (a) Identification. An air-handling apparatus accessory is a 
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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  878.9.

PART 886--OPHTHALMIC DEVICES

0
10. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
11. Add Sec.  886.4355 to subpart F to read as follows:


Sec.  886.4355   Corneal inlay inserter handle.

    (a) Identification. The corneal inlay inserter handle is a 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.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  886.9.

    Dated: April 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07290 Filed 4-11-19; 8:45 am]
 BILLING CODE 4164-01-P


