Medical Devices; Orthopedic Devices; Classification of the In Vivo Cured Intramedullary Fixation Rod, 26577-26580 [2018-12339]
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; and
the collections of information in 21 CFR
part 801, regarding labeling, have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 878.4430 to subpart E to read
as follows:
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■
§ 878.4430 Microneedling device for
aesthetic use.
(a) Identification. A microneedling
device for aesthetic use is a device using
one or more needles to mechanically
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puncture and injure skin tissue for
aesthetic use. This classification does
not include devices intended for
transdermal delivery of topical products
such as cosmetics, drugs, or biologics.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The technical specifications and
needle characteristics must be
identified, including needle length,
geometry, maximum penetration depth,
and puncture rate.
(2) Non-clinical performance data
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Accuracy of needle penetration
depth and puncture rate;
(ii) Safety features built into the
device to protect against crosscontamination, including fluid ingress
protection; and
(iii) Identification of the maximum
safe needle penetration depth for the
device for the labeled indications for
use.
(3) Performance data must
demonstrate the sterility of the patientcontacting components of the device.
(4) Performance data must support the
shelf life of the device by demonstrating
continued sterility, package integrity,
and device functionality over the
intended shelf life.
(5) Performance data must
demonstrate the electrical safety and
electromagnetic compatibility (EMC) of
all electrical components of the device.
(6) Software verification, validation,
and hazard analysis must be performed
for all software components of the
device.
(7) The patient-contacting
components of the device must be
demonstrated to be biocompatible.
(8) Performance data must validate
the cleaning and disinfection
instructions for reusable components of
the device.
(9) Labeling must include the
following:
(i) Information on how to operate the
device and its components and the
typical course of treatment;
(ii) A summary of the device technical
parameters, including needle length,
needle geometry, maximum penetration
depth, and puncture rate;
(iii) Validated methods and
instructions for reprocessing of any
reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided
and must include:
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26577
(i) Information on how the device
operates and the typical course of
treatment;
(ii) The probable risks and benefits
associated with use of the device; and
(iii) Postoperative care instructions.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12335 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2018–N–1863]
Medical Devices; Orthopedic Devices;
Classification of the In Vivo Cured
Intramedullary Fixation Rod
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the in vivo cured
intramedullary fixation rod into class II
(special controls). The special controls
that apply to the device type are
identified in this order and will be part
of the codified language for the in vivo
cured intramedullary fixation rod’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective June 8,
2018. The classification was applicable
on December 19, 2017.
FOR FURTHER INFORMATION CONTACT:
Peter Allen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1512, Silver Spring,
MD 20993–0002, 301–796–6402,
Peter.Allen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
in vivo cured intramedullary fixation
rod as class II (special controls), which
we have determined will provide a
reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation, in part by
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations
reducing regulatory burdens by placing
the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically placed within class III,
the De Novo classification is considered
to be the initial classification of the
device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application in order to market
a substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On December 28, 2016, IlluminOss
Medical, Inc. submitted a request for De
Novo classification of the IlluminOss
Photodynamic Bone Stabilization
System. FDA reviewed the request in
order to classify the device under the
criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
We classify devices into class II if
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness,
but there is sufficient information to
establish special controls that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on December 19, 2017,
FDA issued an order to the requester
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 888.3023. We
have named the generic type of device
in vivo cured intramedullary fixation
rod, and it is identified as a prescription
implanted device consisting of a balloon
that is inserted into the medullary canal
of long bones for the fixation of
fractures. The balloon is infused with,
and completely encapsulates, a liquid
monomer that is exposed to a curing
agent that polymerizes the monomer
within the balloon creating a hardened
rigid structure.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in table
1.
TABLE 1—IN VIVO CURED INTRAMEDULLARY FIXATION ROD RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
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Adverse tissue reaction resulting from: ....................................................
• Balloon leakage.
• Device materials.
Infection, including wound complications .................................................
Bone fracture resulting from: ....................................................................
• Device bending, cracking, or fracture.
• Device migration or instability, including initial inadequate fixation.
• Inability to properly deploy or remove device.
Soft tissue damage including transection or laceration of neural, vascular, or muscular structures.
Pain and/or loss of function resulting from: .............................................
• Balloon leakage.
• Device bending, cracking, or fracture.
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Biocompatibility evaluation and Labeling.
Sterilization validation, Reprocessing validation, Shelf life testing,
Pyrogenicity testing, and Labeling.
Non-clinical performance testing and Labeling.
Non-clinical performance testing and Labeling.
Non-clinical performance testing and Labeling.
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations
26579
TABLE 1—IN VIVO CURED INTRAMEDULLARY FIXATION ROD RISKS AND MITIGATION MEASURES—Continued
Identified risks
Mitigation measures
• Device migration or instability, including initial inadequate fixation.
• Inability to properly deploy or remove device.
Revision ....................................................................................................
Electric shock or interference with other electrical devices .....................
Exothermic reaction leading to tissue injury ............................................
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. For a device
to fall within this classification, and
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
At the time of classification, in vivo
cured intramedullary fixation rods are
for prescription use only. Prescription
devices are exempt from the
requirement for adequate directions for
use for the layperson under section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as
the conditions of 21 CFR 801.109 are
met (referring to 21 U.S.C. 352(f)(1)).
III. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
amozie on DSK3GDR082PROD with RULES
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
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Non-clinical performance testing and Labeling.
Electrical safety testing, Electromagnetic compatibility testing, and Labeling.
Non-clinical performance testing.
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; and
the collections of information in 21 CFR
part 801, regarding labeling, have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 888 is
amended as follows:
PART 888—ORTHOPEDIC DEVICES
1. The authority citation for part 888
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 888.3023 to subpart D to read
as follows:
■
§ 888.3023 In vivo cured intramedullary
fixation rod.
(a) Identification. An in vivo cured
intramedullary fixation rod is a
prescription implanted device
consisting of a balloon that is inserted
into the medullary canal of long bones
for the fixation of fractures. The balloon
is infused with, and completely
encapsulates, a liquid monomer that is
exposed to a curing agent which
polymerizes the monomer within the
balloon creating a hardened rigid
structure.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Mechanical testing must be
conducted on the final device to assess
burst, abrasion, bending, and torsion in
static and dynamic conditions.
(ii) Mechanical testing must
demonstrate the integrity of the balloon
including testing for leaks, ruptures, and
release of cured/uncured material.
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(iii) Performance testing must
demonstrate that the device can be
inserted and removed.
(iv) Performance testing must
demonstrate the ability, in the event of
a leak, to remove the uncured material
from its in vivo location.
(v) Performance testing must
demonstrate the reliability and accuracy
of the curing method used.
(vi) Thermal safety testing must be
conducted to evaluate the temperature
rise during curing.
(2) Electrical safety, electromagnetic
compatibility (EMC) testing, and
electromagnetic interference (EMI)
testing must be conducted for all
electrical components.
(3) All patient-contacting components
must be demonstrated to be
biocompatible.
(4) Performance data must
demonstrate the sterility and
pyrogenicity of patient contacting
components of the device that are
provided sterile.
(5) Performance data must validate
the reprocessing instructions for any
reusable components or instruments.
(6) Performance data must support the
shelf life of the system by demonstrating
continued sterility, package integrity,
and system functionality over the
established shelf life.
(7) Technological characterization of
the device must include materials,
curing agents, and a description of the
operating principles of the device,
including the delivery system and
devices which initiate the curing
process.
(8) Labeling must include the
following:
(i) A detailed summary of the device
technical parameters.
(ii) Information describing all
materials of the device.
(iii) Information describing how to
perform the procedure and use the
device, including the delivery system
and devices which initiate the curing
process, as well as how to remove the
device and any uncured materials.
(iv) A shelf life.
(v) Validated methods and
instructions for reprocessing any
reusable components or instruments.
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Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12339 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9833]
RIN 1545–BO43
Partnership Transactions Involving
Equity Interests of a Partner
Internal Revenue Service (IRS),
Treasury.
ACTION: Final rule.
AGENCY:
This document contains final
regulations that prevent a corporate
partner from avoiding corporate-level
gain through transactions with a
partnership involving equity interests of
the partner or certain related entities.
This document also contains final
regulations that allow consolidated
group members that are partners in the
same partnership to aggregate their
bases in stock distributed by the
partnership for the purpose of limiting
the application of rules that might
otherwise cause basis reduction or gain
recognition. This document also
contains final regulations that may also
require certain corporations that engage
in gain elimination transactions to
reduce the basis of corporate assets or to
recognize gain. These final regulations
affect partnerships and their partners.
DATES:
Effective Date: These final regulations
are effective on June 8, 2018.
Applicability Date: These final
regulations are applicable on or after
June 12, 2015.
FOR FURTHER INFORMATION CONTACT:
Concerning the final regulations, Kevin
I. Babitz, (202) 317–6852.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Background
1. Overview
On June 12, 2015, the Department of
the Treasury (and the IRS published
final and temporary regulations (TD
9722) under section 337(d) of the
Internal Revenue Code (Code) in the
Federal Register (80 FR 33402). On July
8, 2015, corrections to TD 9722 were
published in the Federal Register (80
FR 38940–38941) (together with TD
9722, the temporary regulations). The
temporary regulations expire on June
11, 2018.
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A notice of proposed rulemaking
(REG–149518–03) withdrawing
proposed regulations under section
337(d) published in 1992, and
proposing new proposed regulations by
cross-reference to the temporary
regulations, was published in the
Federal Register (80 FR 33451) on the
same date as TD 9722. Additionally, on
June 12, 2015, the Treasury Department
and the IRS published proposed
regulations (REG–138759–14) under
section 732(f) in the Federal Register
(80 FR 33452) (together with the 2015
proposed regulations under section
337(d), the 2015 regulations).
The Treasury Department and the IRS
received one comment letter in response
to the 2015 regulations. Except as
described below, the commenter largely
supported the 2015 regulations while
recommending some minor
modifications and clarifications to the
2015 regulations under both section
337(d) and section 732(f). The comment
letter is discussed in detail in the
Explanation of Provisions section of this
preamble.
After considering this comment letter,
this Treasury decision adopts as final
regulations the rules set forth in the
2015 regulations under section 337(d)
(with only minor, nonsubstantive
clarifications in response to the
commenter’s request for additional
certainty regarding certain collateral
effects) and section 732(f) (without any
change). However, the Treasury
Department and the IRS are considering
publishing a new notice of proposed
rulemaking to propose more substantive
amendments to the final regulations
under section 337(d) and to allow for
additional public comment with respect
to these more substantive proposals in
response to the comment letter, further
reflection by the Treasury Department
and the IRS, and concerns raised by
practitioners.
2. Regulations Under Section 337(d)
A. Background
In General Utilities & Operating Co. v.
Helvering, 296 U.S. 200 (1935), the
Supreme Court held that corporations
generally could distribute appreciated
property to their shareholders without
the recognition of any corporate level
gain (the General Utilities doctrine).
Beginning with legislation in 1969 and
culminating in the Tax Reform Act of
1986, Public Law 99–514 (100 Stat.
2085) (the Act), Congress repealed the
General Utilities doctrine by enacting
section 336(a) to apply gain and loss
recognition to liquidating distributions.
Under current law, sections 311(b)
and 336(a) require a corporation that
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Sfmt 4700
distributes appreciated property to its
shareholders to recognize gain
determined as if the property were sold
to the shareholders for its fair market
value. Additionally, section 631 of the
Act added section 337(d) to permit the
Secretary to prescribe regulations that
are necessary or appropriate to carry out
the purposes of the General Utilities
repeal, ‘‘including regulations to ensure
that [the repeal of the General Utilities
doctrine] may not be circumvented
through the use of any provision of law
or regulations.’’
After the enactment of sections 311(b)
and 337(d), the Treasury Department
and the IRS became aware of
transactions in which taxpayers used a
partnership to postpone or avoid
completely gain generally required to be
recognized under section 311(b). In one
example of this transaction, a
corporation entered into a partnership
and contributed appreciated property.
The partnership then acquired stock of
that corporate partner, and later made a
liquidating distribution of this stock to
the corporate partner. Under section
731(a), the corporate partner did not
recognize gain on the partnership’s
distribution of its stock. By means of
this transaction, the corporation had
disposed of the appreciated property it
formerly held and had acquired its own
stock, permanently avoiding its gain in
the appreciated property. If the
corporation had directly exchanged the
appreciated property for its own stock,
section 311(b) would have required the
corporation to recognize gain upon the
exchange.
In response to these types of abusive
transactions, the Treasury Department
and the IRS issued Notice 89–37, 1989–
1 CB 679, on March 9, 1989. Notice 89–
37 announced that future regulations
under section 337(d) would address the
use of partnerships to avoid the repeal
of the General Utilities doctrine.
On December 15, 1992, the Treasury
Department and the IRS published a
notice of proposed rulemaking under
section 337(d) (PS–91–90, REG–208989–
90, 1993–1 CB 919) in the Federal
Register (57 FR 59324) addressing
abusive partnership transactions
involving stock of a corporate partner
(the 1992 proposed regulations). The
1992 proposed regulations set forth a
deemed redemption rule and a separate
distribution rule to prevent a corporate
partner from avoiding corporate-level
gain through transactions with a
partnership involving stock of the
corporate partner, stock of the partner’s
affiliate, and other equity interests in
the corporate partner or affiliate. The
1992 proposed regulations treated a
corporation as an affiliate of a partner at
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]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26577-26580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2018-N-1863]
Medical Devices; Orthopedic Devices; Classification of the In
Vivo Cured Intramedullary Fixation Rod
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the in vivo cured intramedullary fixation rod into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the in vivo cured intramedullary fixation rod's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
DATES: This order is effective June 8, 2018. The classification was
applicable on December 19, 2017.
FOR FURTHER INFORMATION CONTACT: Peter Allen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1512, Silver Spring, MD 20993-0002, 301-796-6402,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the in vivo cured intramedullary
fixation rod as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by
[[Page 26578]]
reducing regulatory burdens by placing the device into a lower device
class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less burdensome 510(k)
process, when necessary, to market their device.
II. De Novo Classification
On December 28, 2016, IlluminOss Medical, Inc. submitted a request
for De Novo classification of the IlluminOss Photodynamic Bone
Stabilization System. FDA reviewed the request in order to classify the
device under the criteria for classification set forth in section
513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on December 19, 2017, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 888.3023. We have named
the generic type of device in vivo cured intramedullary fixation rod,
and it is identified as a prescription implanted device consisting of a
balloon that is inserted into the medullary canal of long bones for the
fixation of fractures. The balloon is infused with, and completely
encapsulates, a liquid monomer that is exposed to a curing agent that
polymerizes the monomer within the balloon creating a hardened rigid
structure.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--In Vivo Cured Intramedullary Fixation Rod Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction resulting from: Biocompatibility evaluation and
Labeling.
Balloon leakage...........
Device materials..........
Infection, including wound Sterilization validation,
complications. Reprocessing validation, Shelf
life testing, Pyrogenicity
testing, and Labeling.
Bone fracture resulting from:.......... Non-clinical performance
testing and Labeling.
Device bending, cracking,
or fracture.
Device migration or
instability, including initial
inadequate fixation.
Inability to properly
deploy or remove device.
Soft tissue damage including Non-clinical performance
transection or laceration of neural, testing and Labeling.
vascular, or muscular structures.
Pain and/or loss of function resulting Non-clinical performance
from:. testing and Labeling.
Balloon leakage...........
Device bending, cracking,
or fracture.
[[Page 26579]]
Device migration or
instability, including initial
inadequate fixation.
Inability to properly
deploy or remove device.
Revision............................... Non-clinical performance
testing and Labeling.
Electric shock or interference with Electrical safety testing,
other electrical devices. Electromagnetic compatibility
testing, and Labeling.
Exothermic reaction leading to tissue Non-clinical performance
injury. testing.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
At the time of classification, in vivo cured intramedullary
fixation rods are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:
PART 888--ORTHOPEDIC DEVICES
0
1. The authority citation for part 888 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 888.3023 to subpart D to read as follows:
Sec. 888.3023 In vivo cured intramedullary fixation rod.
(a) Identification. An in vivo cured intramedullary fixation rod is
a prescription implanted device consisting of a balloon that is
inserted into the medullary canal of long bones for the fixation of
fractures. The balloon is infused with, and completely encapsulates, a
liquid monomer that is exposed to a curing agent which polymerizes the
monomer within the balloon creating a hardened rigid structure.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Mechanical testing must be conducted on the final device to
assess burst, abrasion, bending, and torsion in static and dynamic
conditions.
(ii) Mechanical testing must demonstrate the integrity of the
balloon including testing for leaks, ruptures, and release of cured/
uncured material.
(iii) Performance testing must demonstrate that the device can be
inserted and removed.
(iv) Performance testing must demonstrate the ability, in the event
of a leak, to remove the uncured material from its in vivo location.
(v) Performance testing must demonstrate the reliability and
accuracy of the curing method used.
(vi) Thermal safety testing must be conducted to evaluate the
temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing,
and electromagnetic interference (EMI) testing must be conducted for
all electrical components.
(3) All patient-contacting components must be demonstrated to be
biocompatible.
(4) Performance data must demonstrate the sterility and
pyrogenicity of patient contacting components of the device that are
provided sterile.
(5) Performance data must validate the reprocessing instructions
for any reusable components or instruments.
(6) Performance data must support the shelf life of the system by
demonstrating continued sterility, package integrity, and system
functionality over the established shelf life.
(7) Technological characterization of the device must include
materials, curing agents, and a description of the operating principles
of the device, including the delivery system and devices which initiate
the curing process.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how to perform the procedure and use
the device, including the delivery system and devices which initiate
the curing process, as well as how to remove the device and any uncured
materials.
(iv) A shelf life.
(v) Validated methods and instructions for reprocessing any
reusable components or instruments.
[[Page 26580]]
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12339 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
