83 FR 26577 - Medical Devices; Orthopedic Devices; Classification of the In Vivo Cured Intramedullary Fixation Rod
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26577-26580 | |
| FR Document | 2018-12339 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Rules and Regulations] [Pages 26577-26580] From the Federal Register Online [www.thefederalregister.org] [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, Peter.Allen@fda.hhs.gov. 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
![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations 26577
order. The necessary special controls puncture and injure skin tissue for (i) Information on how the device
appear in the regulation codified by this aesthetic use. This classification does operates and the typical course of
order. This device is subject to not include devices intended for treatment;
premarket notification requirements transdermal delivery of topical products (ii) The probable risks and benefits
under section 510(k) of the FD&C Act. such as cosmetics, drugs, or biologics. associated with use of the device; and
(b) Classification. Class II (special (iii) Postoperative care instructions.
III. Analysis of Environmental Impact
controls). The special controls for this Dated: June 4, 2018.
The Agency has determined under 21 device are: Leslie Kux,
CFR 25.34(b) that this action is of a type (1) The technical specifications and Associate Commissioner for Policy.
that does not individually or needle characteristics must be
cumulatively have a significant effect on [FR Doc. 2018–12335 Filed 6–7–18; 8:45 am]
identified, including needle length,
the human environment. Therefore, geometry, maximum penetration depth, BILLING CODE 4164–01–P
neither an environmental assessment and puncture rate.
nor an environmental impact statement (2) Non-clinical performance data
is required. DEPARTMENT OF HEALTH AND
must demonstrate that the device HUMAN SERVICES
IV. Paperwork Reduction Act of 1995 performs as intended under anticipated
conditions of use. The following Food and Drug Administration
This final order establishes special performance characteristics must be
controls that refer to previously tested:
approved collections of information 21 CFR Part 888
(i) Accuracy of needle penetration
found in other FDA regulations and depth and puncture rate; [Docket No. FDA–2018–N–1863]
guidance. These collections of (ii) Safety features built into the
information are subject to review by the Medical Devices; Orthopedic Devices;
device to protect against cross- Classification of the In Vivo Cured
Office of Management and Budget contamination, including fluid ingress
(OMB) under the Paperwork Reduction Intramedullary Fixation Rod
protection; and
Act of 1995 (44 U.S.C. 3501–3520). The (iii) Identification of the maximum AGENCY: Food and Drug Administration,
collections of information in the safe needle penetration depth for the HHS.
guidance document ‘‘De Novo device for the labeled indications for
Classification Process (Evaluation of ACTION: Final order.
use.
Automatic Class III Designation)’’ have SUMMARY: The Food and Drug
(3) Performance data must
been approved under OMB control Administration (FDA or we) is
demonstrate the sterility of the patient-
number 0910–0844; the collections of classifying the in vivo cured
contacting components of the device.
information in 21 CFR part 814, intramedullary fixation rod into class II
(4) Performance data must support the
subparts A through E, regarding (special controls). The special controls
shelf life of the device by demonstrating
premarket approval, have been that apply to the device type are
continued sterility, package integrity,
approved under OMB control number identified in this order and will be part
and device functionality over the
0910–0231; the collections of of the codified language for the in vivo
intended shelf life.
information in part 807, subpart E, cured intramedullary fixation rod’s
(5) Performance data must
regarding premarket notification classification. We are taking this action
demonstrate the electrical safety and
submissions, have been approved under because we have determined that
electromagnetic compatibility (EMC) of
OMB control number 0910–0120; and classifying the device into class II
all electrical components of the device.
the collections of information in 21 CFR (special controls) will provide a
(6) Software verification, validation,
part 801, regarding labeling, have been reasonable assurance of safety and
and hazard analysis must be performed
approved under OMB control number effectiveness of the device. We believe
for all software components of the
0910–0485. this action will also enhance patients’
device.
List of Subjects in 21 CFR Part 878 (7) The patient-contacting access to beneficial innovative devices,
components of the device must be in part by reducing regulatory burdens.
Medical devices.
demonstrated to be biocompatible. DATES: This order is effective June 8,
Therefore, under the Federal Food,
(8) Performance data must validate 2018. The classification was applicable
Drug, and Cosmetic Act and under
the cleaning and disinfection on December 19, 2017.
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is instructions for reusable components of FOR FURTHER INFORMATION CONTACT:
amended as follows: the device. Peter Allen, Center for Devices and
(9) Labeling must include the Radiological Health, Food and Drug
PART 878—GENERAL AND PLASTIC following: Administration, 10903 New Hampshire
SURGERY DEVICES (i) Information on how to operate the Ave., Bldg. 66, Rm. 1512, Silver Spring,
device and its components and the MD 20993–0002, 301–796–6402,
■ 1. The authority citation for part 878 typical course of treatment; Peter.Allen@fda.hhs.gov.
continues to read as follows: (ii) A summary of the device technical SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 351, 360, 360c, 360e, parameters, including needle length,
360j, 360l, 371. needle geometry, maximum penetration I. Background
■ 2. Add § 878.4430 to subpart E to read depth, and puncture rate; Upon request, FDA has classified the
(iii) Validated methods and in vivo cured intramedullary fixation
amozie on DSK3GDR082PROD with RULES
as follows:
instructions for reprocessing of any rod as class II (special controls), which
§ 878.4430 Microneedling device for reusable components; we have determined will provide a
aesthetic use. (iv) Disposal instructions; and reasonable assurance of safety and
(a) Identification. A microneedling (v) A shelf life. effectiveness. In addition, we believe
device for aesthetic use is a device using (10) Patient labeling must be provided this action will enhance patients’ access
one or more needles to mechanically and must include: to beneficial innovation, in part by
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![26580 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Rules and Regulations
Dated: June 4, 2018. A notice of proposed rulemaking distributes appreciated property to its
Leslie Kux, (REG–149518–03) withdrawing shareholders to recognize gain
Associate Commissioner for Policy. proposed regulations under section determined as if the property were sold
[FR Doc. 2018–12339 Filed 6–7–18; 8:45 am] 337(d) published in 1992, and to the shareholders for its fair market
BILLING CODE 4164–01–P proposing new proposed regulations by value. Additionally, section 631 of the
cross-reference to the temporary Act added section 337(d) to permit the
regulations, was published in the Secretary to prescribe regulations that
DEPARTMENT OF THE TREASURY Federal Register (80 FR 33451) on the are necessary or appropriate to carry out
same date as TD 9722. Additionally, on the purposes of the General Utilities
Internal Revenue Service June 12, 2015, the Treasury Department repeal, ‘‘including regulations to ensure
and the IRS published proposed that [the repeal of the General Utilities
26 CFR Part 1 regulations (REG–138759–14) under doctrine] may not be circumvented
section 732(f) in the Federal Register through the use of any provision of law
[TD 9833] or regulations.’’
(80 FR 33452) (together with the 2015
RIN 1545–BO43 proposed regulations under section After the enactment of sections 311(b)
337(d), the 2015 regulations). and 337(d), the Treasury Department
Partnership Transactions Involving The Treasury Department and the IRS and the IRS became aware of
Equity Interests of a Partner received one comment letter in response transactions in which taxpayers used a
to the 2015 regulations. Except as partnership to postpone or avoid
AGENCY: Internal Revenue Service (IRS),
described below, the commenter largely completely gain generally required to be
Treasury.
supported the 2015 regulations while recognized under section 311(b). In one
ACTION: Final rule. example of this transaction, a
recommending some minor
SUMMARY: This document contains final modifications and clarifications to the corporation entered into a partnership
regulations that prevent a corporate 2015 regulations under both section and contributed appreciated property.
partner from avoiding corporate-level 337(d) and section 732(f). The comment The partnership then acquired stock of
gain through transactions with a letter is discussed in detail in the that corporate partner, and later made a
partnership involving equity interests of Explanation of Provisions section of this liquidating distribution of this stock to
the partner or certain related entities. preamble. the corporate partner. Under section
This document also contains final After considering this comment letter, 731(a), the corporate partner did not
regulations that allow consolidated this Treasury decision adopts as final recognize gain on the partnership’s
group members that are partners in the regulations the rules set forth in the distribution of its stock. By means of
same partnership to aggregate their 2015 regulations under section 337(d) this transaction, the corporation had
bases in stock distributed by the (with only minor, nonsubstantive disposed of the appreciated property it
partnership for the purpose of limiting clarifications in response to the formerly held and had acquired its own
the application of rules that might commenter’s request for additional stock, permanently avoiding its gain in
otherwise cause basis reduction or gain certainty regarding certain collateral the appreciated property. If the
recognition. This document also effects) and section 732(f) (without any corporation had directly exchanged the
contains final regulations that may also change). However, the Treasury appreciated property for its own stock,
require certain corporations that engage Department and the IRS are considering section 311(b) would have required the
in gain elimination transactions to publishing a new notice of proposed corporation to recognize gain upon the
reduce the basis of corporate assets or to rulemaking to propose more substantive exchange.
recognize gain. These final regulations In response to these types of abusive
amendments to the final regulations
affect partnerships and their partners. transactions, the Treasury Department
under section 337(d) and to allow for
and the IRS issued Notice 89–37, 1989–
DATES: additional public comment with respect
Effective Date: These final regulations 1 CB 679, on March 9, 1989. Notice 89–
to these more substantive proposals in
are effective on June 8, 2018. 37 announced that future regulations
response to the comment letter, further
Applicability Date: These final under section 337(d) would address the
reflection by the Treasury Department
regulations are applicable on or after use of partnerships to avoid the repeal
and the IRS, and concerns raised by
June 12, 2015. of the General Utilities doctrine.
practitioners. On December 15, 1992, the Treasury
FOR FURTHER INFORMATION CONTACT:
2. Regulations Under Section 337(d) Department and the IRS published a
Concerning the final regulations, Kevin
notice of proposed rulemaking under
I. Babitz, (202) 317–6852. A. Background section 337(d) (PS–91–90, REG–208989–
SUPPLEMENTARY INFORMATION: In General Utilities & Operating Co. v. 90, 1993–1 CB 919) in the Federal
Background Helvering, 296 U.S. 200 (1935), the Register (57 FR 59324) addressing
Supreme Court held that corporations abusive partnership transactions
1. Overview generally could distribute appreciated involving stock of a corporate partner
On June 12, 2015, the Department of property to their shareholders without (the 1992 proposed regulations). The
the Treasury (and the IRS published the recognition of any corporate level 1992 proposed regulations set forth a
final and temporary regulations (TD gain (the General Utilities doctrine). deemed redemption rule and a separate
9722) under section 337(d) of the Beginning with legislation in 1969 and distribution rule to prevent a corporate
Internal Revenue Code (Code) in the culminating in the Tax Reform Act of partner from avoiding corporate-level
Federal Register (80 FR 33402). On July 1986, Public Law 99–514 (100 Stat. gain through transactions with a
amozie on DSK3GDR082PROD with RULES
8, 2015, corrections to TD 9722 were 2085) (the Act), Congress repealed the partnership involving stock of the
published in the Federal Register (80 General Utilities doctrine by enacting corporate partner, stock of the partner’s
FR 38940–38941) (together with TD section 336(a) to apply gain and loss affiliate, and other equity interests in
9722, the temporary regulations). The recognition to liquidating distributions. the corporate partner or affiliate. The
temporary regulations expire on June Under current law, sections 311(b) 1992 proposed regulations treated a
11, 2018. and 336(a) require a corporation that corporation as an affiliate of a partner at
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Document Created: 2018-06-08 01:22:54
Document Modified: 2018-06-08 01:22:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective June 8, 2018. The classification was applicable on December 19, 2017. | |
| 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] | |
| FR Citation | 83 FR 26577 |
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