[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Proposed Rules]
[Pages 67105-67115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2014-N-1205]


Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid 
Pedicle Screw Systems; Classification and Effective Date of Requirement 
for Premarket Approval for Dynamic Stabilization Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing in this 
administrative order to reclassify rigid pedicle screw systems, a

[[Page 67106]]

preamendments class III device, into class II (special controls); 
require the filing of a premarket approval application (PMA) or a 
notice of completion of a product development protocol (PDP) for the 
dynamic stabilization systems, currently a subtype of pedicle screws, 
regardless of the indication for use; and clarify the device 
identification of pedicle screw spinal systems, to more clearly 
delineate between rigid pedicle screw systems and dynamic stabilization 
systems. FDA is proposing this action based on new information 
pertaining to the device type. This proposed action implements certain 
statutory requirements.

DATES: Submit either electronic or written comments on this proposed 
order by February 10, 2015. FDA intends that, if a final order based on 
this proposed order is issued, anyone who wishes to continue to market 
dynamic stabilization systems for the specified intended uses listed in 
section IX will need to file a PMA or a notice of completion of a PDP 
within 90 days of the effective date of the final order. See section 
XVII for the proposed effective date of any final order based on this 
proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-1205, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> Mail/Hand delivery/Courier (For paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1205 for this order. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: 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 document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sergio M. de del Castillo, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-
796-6419, <a href="/cdn-cgi/l/email-protection#c4b7a1b6a3adabeaa0a1a0a1a8a7a5b7b0ada8a8ab84a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="1063756277797f3e747574757c73716364797c7c7f507674713e7878633e777f66">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub. 
L. 107-250), the Medical Devices Technical Corrections Act of 2004 
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive 
system for the regulation of medical devices intended for human use. 
Section 513 of the FD&C Act (21 U.S.C. 360c) established three 
categories (classes) of devices, reflecting the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments devices), are classified after 
FDA has: (1) Received a recommendation from a device classification 
panel (an FDA advisory committee); (2) published the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices) are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification (510(k)) procedures to such a preamendments device or to a 
device within that type may be marketed by means of premarket 
notification procedures (510(k) process) without submission of a PMA 
until FDA issues a final order under section 515(b) of the FD&C Act (21 
U.S.C. 360e(b)) requiring premarket approval.
    Although, under the FD&C Act, the manufacturer of a class III 
preamendments device may respond to the call for PMAs by filing a PMA 
or a notice of completion of a PDP, in practice, the option of filing a 
notice of completion of a PDP has not been used. For simplicity, 
although corresponding requirements for PDPs remain available to 
manufacturers in response to a final order under section 515(b) of the 
FD&C Act, this document will refer only to the requirement for the 
filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended the device reclassification procedures under section 513(e) of 
the FD&C Act, changing the process for reclassifying a device from 
rulemaking to an administrative order. Section 608(b) of FDASIA amended 
section 515(b) of the FD&C Act, changing the process for requiring 
premarket approval for a preamendments class III device from rulemaking 
to an administrative order.

A. Reclassification

    Pedicle screw spinal systems comprise multiple different device 
types:
    Pedicle screw spinal systems (i.e., rigid pedicle screw systems) 
when intended to provide immobilization and stabilization of spinal 
segments in the thoracic, lumbar, and sacral spine as an adjunct to 
fusion in the treatment of degenerative disc disease (DDD) and 
spondylolisthesis (other than either severe spondylolisthesis (grades 3 
and 4) at L5-S1 or degenerative spondylolisthesis with objective 
evidence of neurologic impairment) are class III preamendment devices.
    Dynamic stabilization systems (DSSs), when intended to provide

[[Page 67107]]

immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
DDD and spondylolisthesis (other than either severe spondylolisthesis 
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with 
objective evidence of neurologic impairment), are also class III 
preamendment devices.
    DSSs, when intended to provide immobilization and stabilization of 
spinal segments in the thoracic, lumbar, and sacral spine as an adjunct 
to fusion in the treatment of any of the following acute and chronic 
instabilities or deformities of the thoracic, lumbar, and sacral spine: 
Severe spondylolisthesis (grades 3 and 4) at L5-S1; degenerative 
spondylolisthesis with objective evidence of neurologic impairment; 
fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed 
previous fusion (pseudarthrosis), are class II devices.
    FDA is proposing the reclassification of pedicle screw systems 
(i.e., rigid pedicle screw systems) when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
DDD and spondylolisthesis (other than either severe spondylolisthesis 
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with 
objective evidence of neurologic impairment) from class III to class 
II.
    When intended to provide immobilization and stabilization of spinal 
segments in the thoracic, lumbar, and sacral spine as an adjunct to 
fusion in the treatment of DDD and spondylolisthesis (other than either 
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment), 
the Agency proposes maintaining DSSs in class III. The Agency also 
proposes that DSSs be reclassified from class II to class III when 
intended to provide immobilization and stabilization of spinal segments 
in the thoracic, lumbar, and sacral spine as an adjunct to fusion in 
the treatment of any of the following acute and chronic instabilities 
or deformities of the thoracic, lumbar, and sacral spine: Severe 
spondylolisthesis (grades 3 and 4) at L5-S1; degenerative 
spondylolisthesis with objective evidence of neurologic impairment; 
fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed 
previous fusion (pseudarthrosis). As a result, FDA is proposing that 
all currently marketed DSSs be class III and now require a submission 
of a PMA.
    Section 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section provides that FDA may, 
by administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
of the FD&C Act or an interested person may petition FDA to reclassify 
a preamendments device. The term ``new information,'' as used in 
section 513(e) of the FD&C Act, includes information developed as a 
result of a reevaluation of the data before the Agency when the device 
was originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland Rantos v. 
United States Department of Health, Education, and Welfare, 587 F.2d 
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th 
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available authority (see Bell v. Goddard, supra 366 
F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 
1991)), or in light of changes in ``medical science'' (Upjohn, 422 F.2d 
at 951). Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., 
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens 
Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 
1062 (1985).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register; (2) a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
(3) consideration of comments from all affected stakeholders, including 
patients, payors, and providers. In addition, the proposed order must 
set forth the proposed reclassification, and a substantive summary of 
the valid scientific evidence concerning the proposed reclassification, 
including the public health benefits of the use of the device, and the 
nature and incidence (if known) of the risk of the device. (See section 
513(e)(1)(A)(i) of the FD&C Act.)
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act, if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. FDA has considered rigid pedicle screw systems and decided 
that the device requires premarket notification (510(k) of the FD&C 
Act). Therefore, the Agency does not intend to exempt this proposed 
class II device from premarket notification (510(k)) submission as 
provided under section 510(m) of the FD&C Act.

B. Requirement for Premarket Approval Application

    FDA is proposing to require PMAs for DSSs when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
any of the following indications for use: DDD; spondylolisthesis; 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; 
and failed previous fusion (pseudarthrosis). Section 515(b)(1) of the 
FD&C Act sets forth the process for issuing a final order. 
Specifically, prior to the issuance of a final order requiring 
premarket approval for a preamendments class III device, the following 
must occur: (1) Publication of a proposed order in the Federal 
Register; (2) a meeting of a device classification panel described in 
section 513(b) of the FD&C Act; and (3) consideration of comments from 
all affected stakeholders, including patients, payors, and providers. 
FDA has held a meeting of a device classification panel described in 
section 513(b) of the FD&C Act with respect to DSSs, and therefore, has 
met this requirement under section 515(b)(1) of the FD&C Act. As 
explained further in section X, a meeting of the device classification 
panel described in section 513(b) of the FD&C Act took place in 2013 
(Ref. 1) to discuss whether DSSs should be reclassified or remain in 
class III. The panel recommended that DSSs should be classified as 
class III when intended to provide immobilization and stabilization of 
spinal segments in the thoracic, lumbar, and sacral spine as an

[[Page 67108]]

adjunct to fusion in the treatment of any of the following indications 
for use: DDD; spondylolisthesis; degenerative spondylolisthesis with 
objective evidence of neurologic impairment; fracture; dislocation; 
scoliosis; kyphosis; spinal tumor; and failed previous fusion 
(pseudarthrosis). Section 515(b)(2) of the FD&C Act provides that a 
proposed order to require premarket approval shall contain: (1) The 
proposed order, (2) proposed findings with respect to the degree of 
risk of illness or injury designed to be eliminated or reduced by 
requiring the device to have an approved PMA or a declared completed 
PDP and the benefit to the public from the use of the device, (3) an 
opportunity for the submission of comments on the proposed order and 
the proposed findings, and (4) an opportunity to request a change in 
the classification of the device based on new information relevant to 
the classification of the device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after 
the close of the comment period on the proposed order, consideration of 
any comments received, and a meeting of a device classification panel 
described in section 513(b) of the FD&C Act, issue a final order to 
require premarket approval or publish a document terminating the 
proceeding together with the reasons for such termination. If FDA 
terminates the proceeding, FDA is required to initiate reclassification 
of the device under section 513(e) of the FD&C Act, unless the reason 
for termination is that the device is a banned device under section 516 
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed 
without a PMA until 90 days after FDA issues a final order (a final 
rule issued under section 515(b) of the FD&C Act prior to the enactment 
of FDASIA is considered to be a final order for purposes of section 
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval 
for the device, or 30 months after final classification of the device 
under section 513 of the FD&C Act, whichever is later. For DSSs, the 
preamendments class III devices that are the subject of this proposal, 
the later of these two time periods is the 90-day period. Because these 
devices were classified in 1998, the 30-month period has expired (63 FR 
40025, July 27, 1998). Therefore, if the proposal to require premarket 
approval for DSSs for the uses described above is finalized, section 
501(f)(2)(B) of the FD&C Act requires that a PMA for such device be 
filed within 90 days of the date of issuance of the final order. If a 
PMA is not filed for such device within 90 days after the issuance of a 
final order, the device would be deemed adulterated under section 
501(f) of the FD&C Act.
    DSSs are currently cleared in either one of two classifications--
class II or class III--depending on the indications for use. Therefore, 
two separate actions are proposed in this proposed order. For those 
DSSs that are currently class II, the Agency is proposing to reclassify 
these devices to class III and to require submission of a PMA. For 
those DSSs that are preamendments class III, the Agency is proposing to 
maintain these devices in class III and to require submission of a PMA. 
As stated in the preceding paragraph, for those DSSs that are 
preamendments class III devices, if the proposal to require premarket 
approval for DSSs is finalized, section 501(f)(2)(B) of the FD&C Act 
requires that a PMA for such a device be filed within 90 days of the 
date of issuance of the final order. However, for reasons discussed 
below, FDA does not intend to ensure compliance with the 90-day 
deadline for PMA submission, for those DSSs that are currently in class 
III (for further discussion see sections IX and XII). Also, a 
preamendments device subject to the order process under section 515(b) 
of the FD&C Act is not required to have an approved investigational 
device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous 
with its interstate distribution until the date identified by FDA in 
the final order requiring the filing of a PMA for the device. At that 
time, an IDE is required only if a PMA has not been filed. If the 
manufacturer, importer, or other sponsor of the device submits an IDE 
application and FDA approves it, the device may be distributed for 
investigational use. If a PMA is not filed by the later of the two 
dates, and the device is not distributed for investigational use under 
an IDE, the device is deemed to be adulterated within the meaning of 
section 501(f)(1)(A) of the FD&C Act, and subject to seizure and 
condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its 
distribution continues. Other enforcement actions include, but are not 
limited to, the following: shipment of devices in interstate commerce 
may be subject to injunction under section 302 of the FD&C Act (21 
U.S.C. 332), and the individuals responsible for such shipment may be 
subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 
333). In the past, FDA has requested that manufacturers take action to 
prevent the further use of devices for which no PMA has been filed and 
may determine that such a request is appropriate for the class III 
devices that are the subject of this proposed order, if finalized.
    In accordance with section 515(b)(2) of the FD&C Act, interested 
persons are being offered the opportunity to request reclassification 
of DSS for the uses described previously.

II. Regulatory History of the Device

    In 1998, FDA issued a final rule classifying pedicle screw spinal 
systems as class II devices, when intended to provide immobilization 
and stabilization of spinal segments in the thoracic, lumbar, and 
sacral spine as an adjunct to fusion in the treatment of degenerative 
spondylolisthesis with objective evidence of neurologic impairment, 
fracture, dislocation, scoliosis, kyphosis, tumor, and failed previous 
fusion (63 FR 40025). For all other indications for use, pedicle screw 
spinal systems were deemed class III, for which a PMA is required. 
Classification of these devices followed the recommendations of the 
August 20, 1993, and July 22, 1994, meetings of the Orthopedic and 
Rehabilitation Devices Panel (the Panel). The Panel considered the 
reclassification of pedicle screw spinal systems for all indications, 
and recommended that FDA reclassify only certain indications into class 
II, leaving the other indications, including those of the devices that 
are the subject of this order, as class III devices (60 FR 51946, 
October 4, 1995).
    In 2001, a technical amendment was published in the Federal 
Register to correct several errors and omissions in the July 27, 1998, 
final rule (66 FR 28051, May 22, 2001).
    <bullet> The Agency identified the omission of one indication for 
use within the list of class III uses for pedicle screw spinal 
systems--the treatment of severe spondylolisthesis (grades 3 and 4) at 
the L5-S1 level as an adjunct to fusion. This indication was found to 
fall under preamendments status because devices were marketed for this 
indication prior to 1976.
    <bullet> DDD and spondylolisthesis other than severe 
spondylolisthesis (grades 3 and 4) at L5-S1 were erroneously identified 
as postamendment uses, when in fact these are preamendment uses. While 
this error did not affect the final classification of the device for 
these uses (i.e., class III), it did affect the type of premarket 
submission required. Because these are preamendment uses, a PMA is not 
required until the Agency issues a final order under section 515(b) of 
the FD&C Act (21 U.S.C. 360e(b)) requiring submission of PMAs. Until 
that time, the devices may enter the

[[Page 67109]]

market after clearance of a premarket notification (510(k)) submission.
    <bullet> DDD and spondylolisthesis (other than either severe 
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment) 
were the only class III uses specifically discussed by the panel during 
the August 20, 1993, and July 22, 1994, panel meetings. Therefore, the 
classification regulation was amended to state that pedicle screw 
spinal systems are deemed class III only for these specific uses.
    In 2009, FDA published an order under section 515(i) of the FD&C 
Act (21 U.S.C. 360i) to call for information on the remaining class III 
510(k) preadmendment device, including pedicle screw spinal systems 
when intended to provide immobilization and stabilization of spinal 
segments in the thoracic, lumbar, and sacral spine as an adjunct to 
fusion in the treatment of DDD and spondylolisthesis (other than either 
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment) (74 
FR 16214, April 9, 2009). In response to that order, FDA received 
information from several device manufacturers who all recommended that 
pedicle screw spinal systems described in the preceding sentence should 
be reclassified to class II. The manufacturers stated that safety and 
effectiveness of these devices may be assured via special controls, 
including labeling, biocompatibility, sterility, and mechanical 
testing.
    A meeting of the Orthopedic and Rehabilitation Devices Panel was 
convened on May 22, 2013 (2013 Panel). The 2013 Panel recommended that 
rigid pedicle screw systems should be classified as class II when 
intended to provide immobilization and stabilization of spinal segments 
in the thoracic, lumbar, and sacral spine as an adjunct to fusion in 
the treatment of DDD and spondylolisthesis (other than either severe 
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment). 
The special controls discussed by the 2013 Panel included those 
proposed by device manufacturers in response to the 2009 order; as well 
as an additional control proposed in this order of design 
characteristics. The 2013 Panel also recommended that DSSs, a subset of 
pedicle screw spinal systems, be classified as class III when intended 
to provide immobilization and stabilization of spinal segments in the 
thoracic, lumbar, and sacral spine as an adjunct to fusion, regardless 
of the indications for use, requiring submission of a PMA. FDA is not 
aware of new information that would provide a basis for a different 
recommendation or finding.

III. Device Description

    Pedicle screw spinal systems (i.e., rigid pedicle screw systems) 
are multiple component devices made from a variety of materials that 
allow the surgeon to build an implant system to fit the patient's 
anatomical and physiological requirements. Such a spinal implant 
assembly may consist of a combination of hooks, screws, longitudinal 
members (e.g., plates, rods, plate/rod combinations), transverse or 
cross connectors, and interconnection mechanisms (e.g., rod-to-rod 
connectors, offset connectors). Rigid pedicle screw systems provide 
immediate rigid fixation to the spinal column as an adjunct to spinal 
fusion procedures.
    Since the 1998 final classification, changes in technological 
characteristics have occurred, leading to the emergence of a new type 
of pedicle screw spinal system, known as DSSs. DSSs are a subset of the 
pedicle screw spinal systems regulated under Sec.  888.3070 (21 CFR 
888.3070). DSSs are defined as systems that contain one or more non-
uniform and/or non-metallic longitudinal elements (e.g., polymer cords, 
moveable screw heads, springs) that allow more motion or flexibility 
(e.g., bending, rotation, translation) compared to rigid systems and do 
not provide immediate rigid fixation to the spinal column as an adjunct 
to spinal fusion procedures.
    FDA is proposing to modify the identification language from the way 
it is presently written in Sec.  888.3070(a) to include this technology 
and is also seeking comments on alternative means of providing further 
distinction between rigid pedicle screw systems and DSSs.

IV. Proposed Reclassification

    FDA is proposing that rigid pedicle screw systems subject to this 
order be reclassified from class III to class II. In this proposed 
order, the Agency has identified special controls under section 
513(a)(1)(B) of the FD&C Act that, together with general controls 
(including prescription use), would provide reasonable assurance of 
their safety and effectiveness. Absent the special controls identified 
in this proposed order, general controls applicable to the device are 
insufficient to provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, in accordance with sections 513(e) and 515(i) of the 
FD&C Act and Sec.  860.130, based on new information with respect to 
the devices and taking into account the public health benefit of the 
use of the device and the nature and known incidence of the risk of the 
device, FDA, on its own initiative, is proposing to reclassify this 
preamendments class III device into class II when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
DDD and spondylolisthesis (other than either severe spondylolisthesis 
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with 
objective evidence of neurologic impairment). FDA believes that this 
new information is sufficient to demonstrate that the proposed special 
controls can effectively mitigate the risks to health identified in the 
next section, and that these special controls, together with the 
general controls, will provide a reasonable assurance of safety and 
effectiveness for rigid pedicle screw systems intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
degenerative disc disease and spondylolisthesis other than either 
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt 
class II devices from premarket notification (510(k)) submission. FDA 
has considered rigid pedicle screw systems and decided that the device 
requires premarket notification (510(k) of the FD&C Act). Therefore, 
the Agency does not intend to exempt this proposed class II device from 
premarket notification (510(k)) submission as provided under section 
510(m) of the FD&C Act.
    The Agency is also taking this opportunity to revise the 
identification for pedicle screw spinal systems to distinguish between 
rigid pedicle screw systems currently in class II and DSSs currently in 
class III. The proposal calling for a PMA requirement for DSS is 
discussed in section X.
    In addition, the Agency is taking the opportunity to add the 
following indications for use to Sec.  888.3070--spinal stenosis and 
lordosis (a subset of spinal curvatures and deformities). Spinal 
stenosis and lordosis are conditions that can be treated with fusion 
surgery, which can include the use of rigid pedicle screw systems, and 
the Agency believes that the inclusion of spinal stenosis and lordosis 
in the regulation is appropriate. It is believed

[[Page 67110]]

that the risks to health listed in this document encompass the risks 
associated with treating patients with both spinal stenosis and 
lordosis using rigid pedicle screw systems as part of the procedure. It 
is expected that the special controls identified are appropriate to 
provide reasonable assurance of the safety and effectiveness for rigid 
pedicle screw systems when used as an adjunct to fusion to treat spinal 
stenosis and lordosis. In addition, since the 1998 final 
classification, the Agency has found pedicle screw spinal systems for 
the indications of spinal stenosis and lordosis substantially 
equivalent to devices previously cleared under Sec.  888.3070.

V. Risks to Health

    After considering available information, including the 
recommendations of the advisory committee (panels) for the 
classification of these devices, FDA has evaluated the risks to health 
associated with the use of pedicle screw spinal systems (i.e., rigid 
pedicle screw systems), when intended to provide immobilization and 
stabilization of spinal segments in the thoracic, lumbar, and sacral 
spine as an adjunct to fusion in the treatment of DDD and 
spondylolisthesis (other than either severe spondylolisthesis (grades 3 
and 4) at L5-S1 or degenerative spondylolisthesis with objective 
evidence of neurologic impairment). FDA determined that the following 
risks to health are associated with its use:
    <bullet> Device failure--Components may deform, fracture, wear, 
loosen, or disassemble, resulting in a mechanical or functional 
failure; this may result in back/leg pain, neurological deficit/injury, 
or loss of correction.
    <bullet> Failure at the bone/implant interface--Components may 
loosen, migrate, or disengage from the bone; this may result in back/
leg pain, neurological deficit/injury, or loss of correction.
    <bullet> Tissue injury--Intraoperative and post-operative risks of 
tissue injury include: Bone fracture, injury to blood vessels or 
viscera, neurologic injury, dural tear or cerebrospinal fluid leak and 
skin penetration or irritation, post-operative wound problems including 
infection, and hematoma/seroma.
    <bullet> Adverse tissue reactions--Device material(s) may elicit 
adverse tissue reactions, such as foreign body response, metal allergy, 
and metal toxicity.
    <bullet> Device malposition--Risks of device malposition may 
include difficulty or inability to implant the device components or 
incorrect placement of the device.
    <bullet> Pseudarthrosis--The risk of nonunion, or pseudarthrosis, 
signifies failure of bony fusion and potential instability or pain.
    The risks to health presented to the 2013 Panel such as cardiac, 
respiratory, gastrointestinal, and death are considered general 
surgical risks associated with the surgical procedure to implant rigid 
pedicle screw systems (Ref. 1); these risks are not directly associated 
with rigid pedicle screw systems and therefore are not included in the 
above list of risks. Failure of the rigid pedicle screw system as a 
result of the risks to health listed previously may result in the need 
for reoperation, revision, or removal.
    While presented to the 2013 Panel as a potential risk, graft 
settling would not be considered a device-specific risk. Rather, it 
represents a potential mechanism for the development of pseudarthrosis, 
instability, or lack of correction. Further, graft settling is expected 
in patients undergoing fusion surgery and does not necessarily result 
in adverse clinical sequelae. Thus, this item does not appear in the 
above list.
    The 2013 Panel stated that the risks to health for DSSs appear 
similar to those identified for rigid pedicle screw systems; however, 
as discussed in section X, few data exist to confirm the risk profile 
for these devices. Therefore, the risks to health cannot be fully 
characterized for this device type. FDA is also seeking comments on 
further characterizing the risks to health for DSSs.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used, FDA believes that pedicle screw 
spinal systems (i.e., rigid pedicle screw systems), when intended to 
provide immobilization and stabilization of spinal segments in the 
thoracic, lumbar, and sacral spine as an adjunct to fusion in the 
treatment of degenerative disc disease and spondylolisthesis (other 
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment), should be reclassified into class II because special 
controls, in addition to general controls, can be established to 
provide reasonable assurance of the safety and effectiveness of the 
device, and because general controls themselves are insufficient to 
provide reasonable assurance of its safety and effectiveness. In 
addition, there is now adequate effectiveness information sufficient to 
establish special controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of rigid pedicle screw systems. Therefore, in 
accordance with sections 513(e) and 515(i) of the FD&C Act and Sec.  
860.130, based on new information with respect to the device and taking 
into account the public health benefit of the use of the device and the 
nature and known incidence of the risk of the device, FDA, on its own 
initiative, is proposing to reclassify this preamendments class III 
device into class II. The Agency has identified special controls that 
would provide reasonable assurance of their safety and effectiveness. 
Rigid pedicle screw systems are prescription devices restricted to 
patient use only upon the authorization of a practitioner licensed by 
law to administer or use the device.
    Since the 1998 final classification, when FDA classified pedicle 
screw spinal systems into class III, sufficient evidence has been 
developed to support a reclassification of rigid pedicle screw systems 
to class II with special controls, when such devices are intended to 
provide immobilization and stabilization of spinal segments in the 
thoracic, lumbar, and sacral spine as an adjunct to fusion in the 
treatment of degenerative disc disease and spondylolisthesis (other 
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment). FDA has been reviewing these devices for many years and 
their risks are well known. The risks to health are identified in 
section V, and FDA believes these risks can be adequately mitigated by 
special controls.
    FDA's presentation to the 2013 Panel included a summary of the 
available safety and effectiveness information for rigid pedicle screw 
systems for treatment of the previously described uses, including 
comprehensive reviews of the available literature and adverse event 
reports from the Manufacturer and User Facility Device Experience 
(MAUDE) database. Based on the available safety and effectiveness 
information that supports that rigid pedicle screw systems may be 
beneficial for patients undergoing fusion treatment of the previously 
described conditions, FDA recommended that rigid pedicle screw systems 
be reclassified to class II (special controls) when such devices are 
intended to provide immobilization and stabilization of spinal segments 
in the

[[Page 67111]]

thoracic, lumbar, and sacral spine as an adjunct to fusion in the 
treatment of degenerative disc disease and spondylolisthesis (other 
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment). The 2013 Panel discussed and made recommendations 
regarding the regulatory classification of rigid pedicle screw systems 
to either reconfirm to class III (subject to premarket approval 
application) or reclassify to class II (subject to special controls) as 
directed by section 515(i) of the FD&C Act. The 2013 Panel agreed with 
FDA's conclusion that the available scientific evidence is adequate to 
support the safety and effectiveness of rigid pedicle screw systems for 
these uses.
    The 2013 Panel also agreed with the identified risks to health 
outlined in section V. The 2013 Panel also recommended that allergic 
reaction to the device and its materials should be included as a risk 
to health. FDA agrees with the 2013 Panel's recommendation and has 
included this risk. The 2013 Panel agreed with FDA's proposed special 
controls outlined in section VIII.
    The 2013 Panel transcript and other meeting materials are available 
on FDA's Web site (Ref. 1).

VIII. Proposed Special Controls

    FDA believes that the following special controls, in addition to 
general controls (including applicable prescription-use restrictions 
and continuing 510(k) notification requirements), are sufficient to 
mitigate the risks to health described in section V for rigid pedicle 
screw systems:
    <bullet> The design characteristics of the device, including 
engineering schematics, must ensure that the geometry and material 
composition are consistent with the intended use.
    <bullet> Non-clinical performance testing must demonstrate the 
mechanical function and durability of the implant.
    <bullet> Device components must be demonstrated to be 
biocompatible.
    <bullet> Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
    <bullet> Labeling must specifically include the following:
    [cir] A clear description of the technological features of the 
device including identification of device materials and the principles 
of device operation;
    [cir] intended use and indications for use including levels of 
fixation;
    [cir] identification of magnetic resonance compatibility status;
    [cir] cleaning and sterilization instructions for devices and 
instruments that are provided non-sterile to the end user; and
    [cir] detailed instructions of each surgical step, including device 
removal.
    Table 1 summarizes how FDA believes the risks to health identified 
in section V can be mitigated by the proposed special controls.

                Table 1--Risks to Health and Mitigation Measures for Rigid Pedicle Screw Systems
----------------------------------------------------------------------------------------------------------------
         Identified risks to health                                    Mitigation method
----------------------------------------------------------------------------------------------------------------
Device Failure..............................  Design characteristics.
                                              Non-clinical performance testing.
                                              Labeling.
Failure of Bone Implant Interface...........  Design characteristics.
                                              Biocompatibility.
                                              Non-clinical performance testing.
                                              Labeling.
Tissue Injury...............................  Labeling.
Adverse Tissue Reaction.....................  Design characteristics.
                                              Biocompatibility.
                                              Sterility.
                                              Labeling.
Device Malposition..........................  Labeling.
Pseudoarthrosis.............................  Non-clinical performance testing.
                                              Biocompatibility.
                                              Labeling.
----------------------------------------------------------------------------------------------------------------

    In addition, under 21 CFR 801.109, the sale, distribution and use 
of rigid pedicle screw systems are restricted to prescription use. 
Prescription-use restrictions are a type of general control under 
section 513(a)(1)(A)(i) of the FD&C Act. Under Sec.  807.81, the device 
would continue to be subject to 510(k) notification requirements.
    While the 2013 Panel recommended that training be a special 
control, we believe that the general control of prescription use is an 
adequate substitute. Furthermore, these devices are for prescription 
use only, which makes adequate surgeon training implicit.

IX. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing 
to require that a PMA be filed with the Agency for DSSs that are 
preamendments class III devices within 90 days after issuance of any 
final order based on this proposal. In addition, in accordance with 
section 513(e) of the FD&C Act, FDA is proposing to require that a PMA 
be filed with the Agency for DSSs that will be reclassified from class 
II to class III. An applicant whose device was legally in commercial 
distribution before May 28, 1976, or whose device has been found to be 
substantially equivalent to such a device, will be permitted to 
continue marketing such class III device during FDA's review of the 
PMA, provided that the PMA is timely filed. FDA intends to review any 
PMA for the device within 180 days of the date of filing. FDA cautions 
that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not 
enter into an agreement to extend the review period for a PMA beyond 
180 days unless the Agency finds that ``the continued availability of 
the device is necessary for the public health.''
    Under the FD&C Act, preamendments class III DSSs currently in 
distribution for which no PMA is submitted within 90 days of a final 
order calling for DSS, or for which a denial is rendered on its filed 
PMA, will be considered adulterated under section 501(f)(1) of the FD&C 
Act. Nonetheless, for reasons discussed below, FDA does not intend to 
ensure compliance with the 90-day

[[Page 67112]]

deadline for PMA submissions, for those manufacturers of currently 
marketed class III preamendment DSSs (see further discussion in section 
XII). Instead, FDA is proposing to consider allowing continued 
distribution for manufacturers of currently marketed DSSs who notify 
FDA of their intent to file a PMA within 90 days from the issuance of 
the final order based on this proposal. The notification of the intent 
to file a PMA submission should include a list of all part numbers for 
which a manufacturer plans to seek marketing approval through its PMA. 
FDA proposes further to allow continued distribution for DSS devices 
lawfully distributed for 30 months from the issuance of a final order 
requiring the filing of a PMA for such devices. Manufacturers should be 
able to collect additional scientific evidence, to the extent any is 
necessary, and prepare PMA submissions, in this time. No new devices 
will be allowed into interstate commerce without approval of a PMA. We 
request comment on whether it is appropriate to allow continued 
distribution and, if so, whether the 30 month period proposed is 
reasonable.
    FDA intends that under Sec.  812.2(d), the publication in the 
Federal Register of any final order based on this proposal will include 
a statement that, as of the date on which a PMA is required to be 
filed, the exemptions from the requirements of the IDE regulations for 
preamendments class III devices in Sec.  812.2(c)(1) and (c)(2) will 
cease to apply to any device that is: (1) Not legally on the market on 
or before that date or (2) legally on the market on or before that date 
but for which a PMA is not filed by that date, or for which PMA 
approval has been denied or withdrawn.
    If a PMA for a class III device is not filed with FDA within 90 
days after the date of issuance of any final order requiring premarket 
approval for the device, the device would be deemed adulterated under 
section 501(f) of the FD&C Act. The device may be distributed for 
investigational use only if the requirements of the IDE regulations are 
met. The requirements for significant risk devices include submitting 
an IDE application to FDA for review and approval. An approved IDE is 
required to be in effect before an investigation of the device may be 
initiated or continued under Sec.  812.30. FDA usually recommends that 
IDE applications be submitted to FDA at least 30 days before the end of 
the 90-day period after the issuance of the final order to avoid 
interrupting any ongoing investigations.
    However, FDA does not intend to enforce compliance with IDE and PMA 
requirements for manufacturers of DSSs who notify FDA of their intent 
to file a PMA for such devices within 90 days and file a PMA within 30 
months after the date of issuance of any final order requiring 
premarket approval for these devices. As stated previously in Section 
I.B, because DSSs are currently cleared in either one of two 
classifications--class II or class III--if the proposal to require a 
PMA is finalized, two different requirements would exist for submission 
of a PMA for the same device type (90 days and 30 months, 
respectively). Similarly, if the proposal to require a PMA is 
finalized, two different requirements would exist for an approved IDE 
to be in effect. The Agency believes that all DSS manufacturers should 
be provided the same amount of time to comply with the IDE 
requirements. Therefore, to avoid an imbalance in IDE requirements for 
the same device type, we propose that an approved IDE need not be in 
effect until 30 months after the date of issuance of any final order 
requiring premarket approval for DSSs. FDA recommends that 
manufacturers file a pre-submission to discuss data requirements that 
may be necessary to support their individual PMA submission.
    Unlike DSSs, rigid pedicle screw systems, when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
DDD and spondylolisthesis (other than either severe spondylolisthesis 
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with 
objective evidence of neurologic impairment) can currently be marketed 
after receiving clearance of a 510(k) submission. Because FDA is 
proposing to reclassify these devices as class II requiring clearance 
of a 510(k) submission, this order, if finalized, will not impose any 
new requirements on rigid pedicle screw systems when intended for these 
uses.

X. Device Subject to the Proposal to Require a PMA--DSSs (Proposed 
Sec.  888.3070(a)(2))

A. Identification

    DSSs are a subset of the pedicle screw spinal systems regulated 
under Sec.  888.3070. These systems are defined as systems that contain 
one or more of the following features (including but not limited to): 
Non-uniform or non-metallic longitudinal elements, features that allow 
more motion or flexibility compared to rigid systems, or features that 
do not provide the system immediate rigid fixation. DSSs encompass a 
large variety of designs and may perform differently as compared to 
rigid pedicle screw systems.

B. Summary of Data

    As described and summarized in section X.C, FDA concludes that 
there is very limited valid scientific evidence available for DSSs when 
used as an adjunct to fusion in the treatment of any spinal condition. 
Because of the limited data available, FDA believes that safety and 
effectiveness have not been established, the risks to health cannot be 
fully characterized, special controls cannot be developed, and the 
benefits of DSSs cannot be evaluated. The 2013 Panel agreed that the 
risks appeared similar to those identified for rigid pedicle screw 
systems; however, few data exist to confirm this. The 2013 Panel 
recommended that DSSs should remain in class III (subject to premarket 
approval application) because insufficient information currently exists 
to determine that general controls are sufficient to provide reasonable 
assurance of its safety and effectiveness or that application of 
special controls would provide such assurance.

C. Risks to Health

    As required by section 515(b) of the FD&C Act, FDA is publishing 
its proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that DSSs have 
an approved PMA and (2) the benefits to the public from the use of 
DSSs.
    These findings are based on the reports and recommendations of the 
2013 Panel for the classification of these devices and any additional 
information that FDA has obtained.
    Very limited data currently exist regarding the safety and 
effectiveness of DSSs when used as an adjunct to fusion in the 
treatment of any of the following indications for use: DDD; 
spondylolisthesis; degenerative spondylolisthesis with objective 
evidence of neurologic impairment; fracture; dislocation; scoliosis; 
kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). 
FDA's presentation to the 2013 Panel included a summary of the 
available safety and effectiveness information for DSSs for treatment 
of the above described uses, including identification of the limited 
literature and adverse event reports from the MAUDE database (Ref. 1). 
The limited information from the available published literature, as 
well as confounding factors (e.g., lack of identification of the 
indications for use, data from devices that are not legally marketed in 
the United States), did not

[[Page 67113]]

permit any meaningful conclusions to be drawn. The MAUDE search 
described in section 7.4 of FDA's presentation to the 2013 Panel 
suggests a potentially higher rate of incidence of serious adverse 
events (e.g., device breakage, pain, and reoperation) compared to rigid 
pedicle screw systems; however, the overall number of adverse event 
reports are very low, due to the limited use and distribution of these 
devices. (Ref. 1, FDA Executive Summary, pages 31-33). Given the lack 
of data available for these devices, FDA believes that the safety and 
effectiveness profile for DSSs is not well established, the risks to 
health are not fully characterized for this device subtype, and special 
controls cannot be developed at this time to mitigate the risks to 
health. The 2013 Panel agreed that the DSSs risks appeared similar to 
those listed for rigid pedicle screw systems; however, few data exist 
to confirm the risk profile for these devices. The 2013 Panel 
recommended that DSSs should remain in class III (subject to premarket 
approval application) because insufficient information currently exists 
to determine that general controls are sufficient to provide reasonable 
assurance of its safety and effectiveness or that application of 
special controls would provide such assurance.
    Because the benefits of DSSs for the above described uses are 
unknown, it is not currently possible to truly estimate the direct 
effect of the DSSs on patient outcomes. However, claims for the devices 
state the devices have the potential to benefit the public in the 
following ways: Reduced risk for screw fracture and reduced stress-
shielding at the treated level.

XI. PMA Requirements

    A PMA for a DSS, when used as an adjunct to fusion in the treatment 
of any spinal condition, must include the information required by 
section 515(c)(1) of the FD&C Act. Such a PMA should also include a 
detailed discussion of the risks to health, as well as a discussion of 
the effectiveness of the device for which premarket approval is sought. 
In addition, a PMA must include all data and information on: (1) Any 
risks known, or that should be reasonably known, to the applicant that 
have not been identified in this document; (2) the effectiveness of the 
device that is the subject of the application; and (3) full reports of 
all preclinical and clinical information from investigations on the 
safety and effectiveness of the device for which premarket approval is 
sought. A PMA must include valid scientific evidence to demonstrate 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see Sec.  860.7(c)(1)). Valid scientific evidence is 
``evidence from well-controlled investigations, partially controlled 
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports 
of significant human experience with a marketed device, from which it 
can fairly and responsibly be concluded by qualified experts that there 
is reasonable assurance of the safety and effectiveness of a device 
under its conditions of use . . . Isolated case reports, random 
experience, reports lacking sufficient details to permit scientific 
evaluation, and unsubstantiated opinions are not regarded as valid 
scientific evidence to show safety or effectiveness.'' (See Sec.  
860.7(c)(2).)

XII. Implementation Strategy for Currently Marketed DSSs

    For clarification, if this proposed order is finalized, and under 
section 501(f)(2)(B), PMAs for currently marketed DSSs are required to 
be filed on or before 90 days after the date of issuance of a final 
order in the Federal Register. However, for currently marketed DSSs, 
FDA does not intend to ensure compliance with this 90-day deadline 
until 30 months after that deadline (i.e., 33 months after the issuance 
of the final order) for class III preamendments DSSs, as long as notice 
of intent to file a PMA is submitted within 90 days of issuance of the 
final order. The notification of the intent to file a PMA submission 
must include a list of all part numbers for which a manufacturer plans 
to seek marketing approval through its PMA. Manufacturers should be 
able to collect additional scientific evidence, to the extent any is 
necessary, and prepare PMA submissions, in this time. No new devices 
will be allowed into interstate commerce without approval of a PMA.
    In conducting any clinical studies, DSSs may be distributed for 
investigational use if the requirements of the IDE regulations (part 
812) are met. There will be neither extended period for filing an IDE 
nor exemption from IDE requirements, and studies may not be initiated 
without appropriate IDE approvals, where necessary.

XIII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA for a device, FDA is required 
by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for 
interested persons to request a change in the classification of the 
device based on new information relevant to the classification. Any 
proceeding to reclassify the device will be under the authority of 
section 513(e) of the FD&C Act.
    A request for a change in the classification of DSSs, when used as 
an adjunct to fusion in the treatment of any spinal condition, is to be 
in the form of a reclassification petition containing the information 
required by Sec.  860.123, including new information relevant to the 
classification of the device.

XIV. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices and section 
515(b) of the FD&C Act provided for FDA to issue regulations to require 
approval of an application for PMA for preamendments devices or devices 
found to be substantially equivalent to preamendments devices. Because 
sections 513(e) and 515(b) of the FD&C Act, as amended by FDASIA, 
require FDA to issue final orders rather than regulations, FDA will 
continue to codify reclassifications and requirements for approval of a 
PMA, resulting from changes issued in final orders, in the CFR.
    Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as 
amended by FDASIA, in this proposed order, we are proposing to revoke 
the requirements in Sec.  888.3070 related to the classification of 
rigid pedicle screw systems when used for immobilization and 
stabilization as an adjunct to fusion in the treatment of DDD and 
spondylolisthesis (other than either severe spondylolisthesis (grades 3 
and 4) at L5-S1 or degenerative spondylolisthesis with objective 
evidence of neurologic impairment) as class III devices and to codify 
the reclassification of rigid pedicle screw systems when used for 
immobilization and stabilization as an adjunct to fusion in the 
treatment of DDD and spondylolisthesis (other than either severe 
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment) 
into class II.

XV. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

[[Page 67114]]

XVI. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that 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 21 CFR part 814 have been approved under 
OMB control number 0910-0231. The collections of information in part 
807, subpart E, have been approved under OMB control number 0910-0120.
    The effect of this order, if finalized, is to shift DSSs devices 
from the 510(k) premarket notification process to the PMA process. To 
account for this change, FDA intends to transfer some of the burden 
from OMB control number 0910-0120, which is the control number for the 
510(k) premarket notification process, to OMB control number 0910-0231, 
which is the control number for the PMA process. FDA estimates that it 
will receive 16 new PMAs for DSS as a result of this order, if 
finalized. Based on FDA's most recent estimates, this will result in 
16,601 hours burden increase to OMB control number 0910-0231. FDA also 
estimates that there will be 16 fewer 510(k) submissions as a result of 
this order, if finalized. Based on FDA's most recent estimates, this 
will result in 2,179 hours decrease to OMB control number 0910-0120. 
Therefore, on net, FDA expects a burden hour increase of 14,422 hours 
due to this proposed regulatory change.
    The collections of information in part 812 have been approved under 
OMB control number 0910-0078.

XVII. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become 
effective on the date of its publication in the Federal Register or at 
a later date if stated in the final order.

XVIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIX. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. FDA, the May 22, 2013 Panel transcript and other meeting 
materials (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm352525.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, it is 
proposed that 21 CFR part 888 be amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for 21 CFR part 888 continues to read as 
follows:

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

0
2. Section 888.3070 is amended by revising paragraphs (a) and (b)(2), 
adding paragraph (b)(3), and revising paragrpah (c) to read as follows:


Sec.  888.3070  Pedicle screw spinal system.

    (a) Identification. (1) Rigid pedicle screw systems are 
prescription devices comprised of multiple components, made from a 
variety of materials that allow the surgeon to build an implant system 
to fit the patient's anatomical and physiological requirements. Such a 
spinal implant assembly consists of a combination of hooks, screws, 
longitudinal members (e.g., plates, rods, plate/rod combinations), 
transverse or cross connectors, and interconnection mechanisms (e.g., 
rod-to-rod connectors, offset connectors). These systems are intended 
for immediate rigid fixation as an adjunct to fusion.
    (2) Dynamic stabilization systems are defined as systems that 
contain one or more non-uniform and/or non-metallic longitudinal 
elements (e.g., polymer cords, moveable screw heads, springs) that 
allow more motion or flexibility (e.g., bending, rotation, translation) 
compared to rigid pedicle screw systems and do not provide immediate 
rigid fixation to the spinal column as an adjunct fusion.
    (b) * * *
    (2) Class II (special controls), when a rigid pedicle screw system 
is intended to provide immobilization and stabilization of spinal 
segments in the thoracic, lumbar, and sacral spine as an adjunct to 
fusion in the treatment of degenerative disc disease and 
spondylolisthesis other than either severe spondylolisthesis (grades 3 
and 4) at L5-S1 or degenerative spondylolisthesis with objective 
evidence of neurologic impairment. These pedicle screw spinal systems 
must comply with the following special controls:
    (i) The design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (ii) Non-clinical performance testing must demonstrate the 
mechanical function and durability of the implant.
    (iii) Device components must be demonstrated to be biocompatible.
    (iv) Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
    (v) Labeling must bear all information required for the safe and 
effective use of the device, specifically including the following:
    (A) A clear description of the technological features of the device 
including identification of device materials and the principles of 
device operation;
    (B) Intended use and indications for use including levels of 
fixation;
    (C) Identification of magnetic resonance compatibility status;
    (D) Cleaning and sterilization instructions for devices and 
instruments that are provided nonsterile to the end user; and
    (E) Detailed instructions of each surgical step, including device 
removal.
    (3) Class III (premarket approval) when a dynamic stabilization 
system is intended to provide stabilization of spinal segments in the 
thoracic, lumbar, and sacral spine as an adjunct to fusion for any 
indication.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before [DATE 90 DAYS AFTER DATE OF 
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER] for any 
dynamic stabilization system that was in commercial distribution before 
May 28, 1976, or that has, on or before [DATE 90 DAYS AFTER DATE OF 
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER] been found 
to be substantially equivalent to a pedicle

[[Page 67115]]

screw spinal system that was in commercial distribution before May 28, 
1976. Any other dynamic stabilization system shall have an approved PMA 
or a declared completed PDP in effect before being placed in commercial 
distribution.

    Dated: November 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26726 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P


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