[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12088-12093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2015-N-3785]
RIN 0910-AI00
Medical Devices; Orthopedic Devices; Classification of Posterior
Cervical Screw Systems
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to classify posterior cervical screw systems into
class II (special controls) and to continue to require a premarket
notification (510(k)) to provide a reasonable assurance of safety and
effectiveness of the device. A posterior cervical screw system is a
device used to provide immobilization and stabilization in the cervical
spine as an adjunct to spinal fusion surgery. The term ``posterior
cervical screw systems'' is used to distinguish these devices from
currently classified thoracolumbosacral pedicle screw systems for use
in other spinal regions.
DATES: This rule is effective May 1, 2019.
ADDRESSES: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule 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: Genevieve McRae, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1457, Silver Spring, MD 20993-0002, 301-
796-6423, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. History of This Rulemaking
B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
C. Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference
I. Executive Summary
A. Purpose of the Final Rule
Through this final rule, FDA is classifying posterior cervical
screw systems (product code NKG) into class II (special controls). This
decision was based upon the recommendation of the Orthopaedic and
Rehabilitation Devices Panel (the Panel) and our consideration and
analysis of the public comments received following the publication of
the proposed rule. FDA believes that the special controls established
and imposed by this final rule, together with
[[Page 12089]]
the general controls, will provide a reasonable assurance of safety and
effectiveness of the device.
B. Summary of the Major Provisions of the Final Rule
This final rule revises the identification language for posterior
cervical screw systems, classifies posterior cervical screw systems
into class II (special controls), and establishes the following special
controls for posterior cervical screw systems with which manufacturers
must comply: (1) The design characteristics of the device ensure that
the geometry and material composition are consistent with the intended
use of the device; (2) nonclinical performance testing must demonstrate
mechanical function and durability of the implant; (3) device
components must be demonstrated to be biocompatible; (4) validation
testing must demonstrate the cleanliness and sterility of, or the
ability to clean and sterilize, the device components and device-
specific instruments; and (5) device labeling must include a clear
description of the technological features of the device, the intended
use and indications for use, and certain specified device-specific
warnings, precautions, and contraindications.
C. Legal Authority
FDA is issuing this rule under the authority of the provisions of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to
medical devices (21 U.S.C. 301 et seq.), including section 513(a)
regarding device classes (21 U.S.C. 360c(a)), section 513(b) and (c)
regarding device classification panels, and section 513(d) regarding
device classification.
D. Costs and Benefits
We estimate that the final rule will affect 32 manufacturers of 38
products. Manufacturers of these affected products will incur one-time
costs of $78.69 each to read and understand the rule, and will incur
one-time labeling costs of $13,189 for each product. The present value
of the total costs is estimated at $503,700. The annualized cost of
this rule over 10 years is estimated to be $62,777 at a 7 percent
discount rate and $52,853 at a 3 percent discount rate. We did not
estimate quantifiable benefits of the final rule.
II. Background
A. History of This Rulemaking
In the Federal Register of March 10, 2016 (81 FR 12607), FDA issued
a proposed rule to classify posterior cervical screw systems as class
II with special controls, and proposed special controls for these
devices, and invited interested persons to comment on the proposed
regulation by June 8, 2016. These recommendations were based upon
feedback received from the Panel on September 21, 2012.
B. Summary of Comments to the Proposed Rule
FDA received four sets of comments on the proposed rule from trade
organizations, professional societies, and an individual. The comments
within the scope of FDA's proposal to classify posterior cervical screw
systems into class II (special controls) were supportive and included a
few suggested clarifications and/or changes to the language of the
proposed rule. We considered all comments in the development of this
final rule and accepted several suggested changes, as discussed in
section IV below.
III. Legal Authority
The FD&C Act (21 U.S.C. 301 et seq.), as amended, established a
comprehensive system for the regulation of medical devices intended for
human use. The FD&C Act establishes three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness (section 513(a)
of the FD&C Act). The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Class I devices are those devices for which the general controls of
the FD&C Act (controls authorized by or under the general controls
sections of the FD&C Act (sections 501, 502, 510, 516, 518, 519, or
520) (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j), or any
combination of such sections) are sufficient to provide a reasonable
assurance of the safety and effectiveness of the device; or those
devices for which insufficient information exists to determine that
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device or to establish special controls
to provide such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act).
Class II devices are those devices for which general controls by
themselves are insufficient to provide reasonable assurance of the
safety and effectiveness, and for which there is sufficient information
to establish special controls to provide such assurance, including the
promulgation of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions as the Agency deems
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C
Act).
Class III devices are those devices for which insufficient
information exists to determine that general controls and special
controls would provide a reasonable assurance of safety and
effectiveness, and are purported or represented for a use in supporting
or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health, or present a
potential unreasonable risk of illness or injury (section 513(a)(1)(C)
of the FD&C Act).
FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the Medical Device Amendments of
1976), as ``preamendments devices.'' Pursuant to section 513(d)(1) of
the FD&C Act, FDA classifies these devices after FDA: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device (section 513(d)(1) of the FD&C
Act). FDA has classified most preamendments devices under these
procedures and has followed these procedures to classify posterior
cervical screw systems.
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
FDA received four sets of comments on the proposed rule by the
close of the comment period. One of the comments received was regarding
a different device type that is not associated with posterior cervical
screw systems and is thus outside the scope of the rule. We describe
and respond to the applicable comments in section IV.B and C. We have
grouped certain comments under the same number because the subject
matter of the comments is similar; conversely, in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments, with separate numbers. The number assigned
to each comment or comment topic is purely for organizational purposes
and does not signify the comment's value or
[[Page 12090]]
importance or the order in which it was received.
B. Description of General Comments and FDA Response
All comments within the scope of the rulemaking support FDA's
proposed classification of posterior cervical screw systems into class
II (special controls). One commenter notes that it supports the
proposed classification of the device because ``the use of posterior
cervical screw systems has been the standard of care for surgical
management of cervical spine disorders arising from tumor, trauma,
degerative [sic] disease and deformity for approximately 20 years.''
FDA agrees that the device type is well understood, which enables the
establishment of special controls that provide a reasonable assurance
of safety and effectiveness for these devices.
C. Specific Comments and FDA Response
(Comment 1) A commenter suggests removing the phrase ``utilizing
pedicle and lateral mass screws'' when identifying and referring to
posterior cervical screw systems as there are additional screw types
that fall within these systems.
(Response 1) FDA agrees with this comment and has revised each
relevant instance of this language within the regulation accordingly
(i.e., the recommended Precaution statement in Sec.
888.3075(b)(5)(iii)(A) (21 CFR 888.3075(b)(5)(iii)(A)).
(Comment 2) A commenter recommends revising the proposed
identification of ``posterior cervical screw systems'' to remove the
specification of spinal levels for specific screw types listed in the
identification and replacing it with a range of spinal levels
applicable to all screw types utilized in the device.
(Response 2) FDA disagrees with the proposed edits to the
identification language. Evidence in the scientific literature is not
adequate to support the use of pars screws, translaminar screws, and
transarticular screws outside of the specified level (C2) based upon
anatomic differences between C2 and other levels. Therefore, this
change is not accepted.
(Comment 3) A commenter notes that, while the preamble to the
proposed rule specified that posterior cervical screw systems do not
include dynamic features, the examples of dynamic features listed in
the proposed identification language included ``non-uniform'' elements,
which could be interpreted to include dual-diameter rods that may be a
component of current posterior cervical screw systems. A dual-diameter
rod is a rigid rod that transitions between two different diameters
along its length.
(Response 3) FDA agrees that dual-diameter rods are often part of
rigid posterior cervical screw systems and that the proposed
identification language should be revised to clarify that dual diameter
rods or plate/rod combinations are examples of ``longitudinal
members,'' which may be included in posterior cervical screw systems.
We have also revised the identification to specify that posterior
cervical screw systems are rigidly fixed devices that do not contain
dynamic features, including but not limited to, non-uniform
longitudinal elements or features that allow more motion or flexibility
compared to rigid systems.
(Comment 4) A commenter notes inconsistencies or errors in the
indications for use in the proposed rule.
(Response 4) FDA agrees with this comment and has revised the
indications for use within Sec. 888.3075 to correct the noted errors.
FDA has also clarified the language specifying the indications for use
by replacing ``degenerative disease'' with ``degeneration'' to more
appropriately reference the state to be treated and replacing
``radiographic studies'' with ``imaging studies (radiographs, computed
tomography, magnetic resonance imaging)'' to account for the various
imaging modalities that may be used in preoperative planning prior to
implantation of a posterior cervical screw system.
(Comment 5) A commenter suggests that ``wear'' be removed from the
list of potential means by which a device could fail.
(Response 5) FDA disagrees with this comment. Posterior cervical
screw systems are comprised of multiple interconnecting components that
have the potential to generate wear during spinal motion. Therefore,
the definition of device failure has not been modified.
(Comment 6) A commenter recommends removing ``design
characteristics'' as a special control because this item should be a
requirement of all premarket notifications.
(Response 6) FDA disagrees with this comment. FDA considers the
``design characteristics'' special control necessary to help
differentiate technological features for rigid posterior cervical screw
systems, included within the scope of this regulation, from features
considered to be dynamic.
(Comment 7) A commenter recommends revising the biocompatibility
special control to be ``compliance with biocompatibility standards''
rather than ``[d]evice components must be demonstrated to be
biocompatible'' because the majority of posterior cervical screw
systems are made of materials that have a long history of safe use and,
as such, are compatible with standards. Testing for compliance with
biocompatibility standards would be relevant only for alternative or
new materials.
(Response 7) FDA disagrees with this comment. The FD&C Act and
FDA's regulations allow for flexibility in the methods for addressing
certain regulatory requirements. Specifically, the substantial
equivalence section of the FD&C Act (section 513(i)(1)(D)) states
whenever the Secretary of Health and Human Services (the Secretary)
requests information to demonstrate that devices with differing
technological characteristics are substantially equivalent, the
Secretary shall only request information that is necessary to making
substantial equivalence determinations. In making such a request, the
Secretary shall consider the least burdensome means of demonstrating
substantial equivalence and request information accordingly. Hence,
there may be alternatives to FDA-recognized consensus standards to
satisfy the special control related to the biocompatibility of devices
within this device type.
(Comment 8) A commenter suggests modifying the first precaution
within the labeling special control (Sec. 888.3075(b)(5)(iii)(a)) to
include ``nerve roots'' as an anatomical structure to consider during
preoperative planning.
(Response 8) FDA agrees with this comment. This precaution has been
revised to include a reference to ``neurologic structures.''
(Comment 9) A commenter suggests that, within the Economic Analysis
section of the proposed rule, it is unclear whether or not the required
addition of precautions to the device labeling would require
manufacturers to submit a new 510(k) for devices already on the market
and recommends that we explicitly state that such a submission would
not be required to revise the labeling for devices already on the
market to add the precautions.
(Response 9) FDA disagrees with this comment. As in the proposed
rule, the language in the Economic Analysis of the final rule (see Ref.
1) states, ``It is not expected that manufacturers of devices already
on the market would need to submit new 510(k) notifications, 510(k)
amendments, or add-to-files to demonstrate conformance with the special
controls,'' which includes the
[[Page 12091]]
addition of the specified precaution statement.
(Comment 10) A commenter recommends minor editorial revisions to
the risks and descriptive text associated with risks as outlined in the
proposed rule.
(Response 10) FDA disagrees with this comment. The recommended
edits were minor and would not substantively change the meaning of the
risks and associated mitigations for the device; therefore, we do not
accept these suggested edits in this final rule.
V. Effective Date
This final rule will become effective 30 days after its publication
in the Federal Register.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We have identified 16 manufacturers that could be considered
small entities. Two of these manufacturers each produce two devices
covered by this rule. Because our final regulatory impact analysis
finds that more small entities will incur relatively low costs to
comply with the final rule than estimated in our preliminary regulatory
impact analysis, we have decided not to certify the final rule and find
that the final rule will not have a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $150
million, using the most current (2017) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This final rule classifies posterior cervical screw systems as
class II devices with special controls. Although these devices are
currently unclassified, manufacturers are subject to premarket
requirements similar to class II devices, with manufacturers receiving
clearance to market via a 510(k) submission without a PMA requirement.
We have concluded that special controls in addition to general controls
are sufficient to reasonably ensure the safety and effectiveness of
these devices and that these devices may be classified as class II
(special controls).
Table 1 provides the Regulatory Information Service Center and
Office of Information and Regulatory Affairs Combined Information
System accounting information for this analysis.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
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Units
Primary ------------------------------------------------
Category estimate Low estimate High estimate Discount rate Period covered Notes
Year dollars (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized .............. .............. .............. 2016 7 10 .......................
$millions/year. 2016 3 10
Annualized Quantified...... .............. .............. .............. 2016 7 10 .......................
2016 3 10
Qualitative
Costs:
Annualized Monetized 0.063 .............. .............. 2016 7 10 .......................
$millions/year. 0.053 2016 3 10
Annualized Quantified...... .............. .............. .............. 2016 7 10 .......................
2016 3 10
Qualitative
Transfers:
Federal Annualized .............. .............. .............. 2016 7 10 .......................
Monetized $millions/year. 2016 3 10
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From:
To: ..............
------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .............. .............. .............. 2016 7 10 .......................
$millions/year. 2016 3 10
------------------------------------------------------------------------------------------------------------------------
From:
To: ..............
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Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business:.....................................................................................................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
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In line with Executive Order 13771, in table 2, we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these costs, we consider this final rule a regulatory
action under Executive Order 13771.
[[Page 12092]]
Table 2--E.O. 13771 Summary Table
[In $ millions 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Upper bound Lower bound Upper bound
Primary (7%) (7%) (7%) Primary (3%) (3%) (3%)
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Present Value of Costs.................................. 0.5 .............. .............. 0.5 .............. ..............
Present Value of Cost Savings........................... .............. .............. .............. .............. .............. ..............
Present Value of Net Costs.............................. 0.5 .............. .............. 0.5 .............. ..............
Annualized Costs........................................ 0.033 .............. .............. 0.015 .............. ..............
Annualized Cost Savings................................. .............. .............. .............. .............. .............. ..............
Annualized Net Costs.................................... 0.033 .............. .............. 0.015 .............. ..............
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We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VII. Analysis of Environmental Impact
We have 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.
VIII. Paperwork Reduction Act of 1995
This final rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information
in 21 CFR part 807, subpart E, have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485; and the
collections of information in 21 CFR part 807 have been approved under
OMB control number 0910-0625. The precaution labeling provisions in
Sec. 888.3075(b)(5) are not subject to review by OMB because they do
not constitute a ``collection of information'' under the PRA. Rather,
the following labeling in Sec. 888.3075(b)(5)(iii)(A) and
(b)(5)(iii)(B) is a public disclosure of information originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public (5 CFR 1320.3(c)(2)).
IX. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.
X. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
1. The full analysis of economic impacts is available in Docket
No. FDA-2015-N-3785 for this final rule at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
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 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 888.3075 to subpart D to read as follows:
Sec. 888.3075 Posterior cervical screw system.
(a) Identification. Posterior cervical screw systems are comprised
of multiple, interconnecting components, made from a variety of
materials that allow an implant system to be built from the occiput to
the upper thoracic spine to fit the patient's anatomical and
physiological requirements, as determined by preoperative cross-
sectional imaging. Such a spinal assembly consists of a combination of
bone anchors via screws (i.e., occipital screws, cervical lateral mass
screws, cervical pedicle screws, C2 pars screws, C2 translaminar
screws, C2 transarticular screws), longitudinal members (e.g., plates,
rods, including dual diameter rods, plate/rod combinations), transverse
or cross connectors, interconnection mechanisms (e.g., rod-to-rod
connectors, offset connectors), and closure mechanisms (e.g., set
screws, nuts). Posterior cervical screw systems are rigidly fixed
devices that do not contain dynamic features, including but not limited
to: non-uniform longitudinal elements or features that allow more
motion or flexibility compared to rigid systems.
Posterior cervical screw systems are intended to provide
immobilization and stabilization of spinal segments in patients as an
adjunct to fusion for acute and chronic instabilities of the cervical
spine and/or craniocervical junction and/or cervicothoracic junction
such as: (1) Traumatic spinal fractures and/or traumatic dislocations;
(2) deformities; (3) instabilities; (4) failed previous fusions (e.g.,
pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal
degeneration, including neck and/or arm pain of discogenic origin as
confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration
of the facets with instability; and (9) reconstruction following
decompression to treat radiculopathy and/or myelopathy. These systems
are also intended to restore the integrity of the spinal column even in
the absence of fusion for a limited time period in patients with
advanced stage tumors involving the cervical spine in whom life
expectancy is of insufficient duration to permit achievement of fusion.
[[Page 12093]]
(b) Classification. Class II (special controls). The special
controls for posterior cervical screw systems are:
(1) The design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical
function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device
including identification of device materials and the principles of
device operation;
(ii) Intended use and indications for use including levels of
fixation;
(iii) Device specific warnings, precautions, and contraindications
that include the following statements:
(A) ``Precaution: Preoperative planning prior to implantation of
posterior cervical screw systems should include review of cross-
sectional imaging studies (e.g., CT and/or MRI) to evaluate the
patient's cervical anatomy including the transverse foramen, neurologic
structures, and the course of the vertebral arteries. If any findings
would compromise the placement of these screws, other surgical methods
should be considered. In addition, use of intraoperative imaging should
be considered to guide and/or verify device placement, as necessary.''
(B) ``Precaution: Use of posterior cervical pedicle screw fixation
at the C3 through C6 spinal levels requires careful consideration and
planning beyond that required for lateral mass screws placed at these
spinal levels, given the proximity of the vertebral arteries and
neurologic structures in relation to the cervical pedicles at these
levels.''
(iv) Identification of magnetic resonance (MR) compatibility
status;
(v) Cleaning and sterilization instructions for devices and
instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device
removal.
Dated: March 22, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06024 Filed 3-29-19; 8:45 am]
BILLING CODE 4164-01-P