Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 67105 

providing an incentive for entities to 

remit their assessments in a timely 

manner, with the intent of creating a fair 

and equitable process among all 

assessed entities. 

Additionally, as previously 

mentioned, the Order provides for an 

exemption for entities that produce or 

import less than 20,000 pounds of 

processed raspberries annually. About 

140 producers of raspberries for 

processing and 80 importers of 

processed raspberries pay assessments 

under the Order. 

Regarding alternatives, one option to 

the proposed action would be to 

maintain the status quo and not 

prescribe late payment and interest 

charges for past due assessments. 

However, the Council determined that 

implementing such charges would help 

facilitate program administration by 

encouraging entities to pay their 

assessments in a timely manner. The 

Council reviewed rates of late payment 

and interest charges prescribed in other 

research and promotion programs and 

concluded that a 10 percent late 

payment charge and interest at a rate of 

1 percent per month on the outstanding 

balance would be appropriate. 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35), the information collection 

and recordkeeping requirements that are 

imposed by the Order have been 

approved under OMB control number 

0581–0093. This proposed rule would 

not result in a change to the information 

collection and recordkeeping 

requirements previously approved and 

would impose no additional reporting 

and recordkeeping burden on domestic 

producers, first handlers, and importers 

of processed raspberries. 

As with all Federal promotion 

programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. Finally, USDA has not 

identified any relevant Federal rules 

that duplicate, overlap, or conflict with 

this proposed rule. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

Regarding outreach efforts, the 

Council met on January 15, 2014, and 

unanimously made its recommendation. 

All of the Council’s meetings, including 

meetings held via teleconference, are 

open to the public and interested 

persons are invited to participate and 

express their views. 

We have performed this initial RFA 

regarding the impact of this proposed 

action on small entities and we invite 

comments concerning potential effects 

of this action on small businesses. 

While this proposed rule set forth 

below has not received the approval of 

USDA, it has been determined that it is 

consistent with and would effectuate 

the purposes of the 1996 Act. 

A 30-day comment period is provided 

to allow interested persons to respond 

to this proposal. Thirty-days is deemed 

appropriate because the Council would 

like to implement this incentive as soon 

as possible to facilitate the collection of 

assessments on a timely basis. All 

written comments received in response 

to this proposed rule by the date 

specified will be considered prior to 

finalizing this action. 

List of Subjects in 7 CFR Part 1208 

Administrative practice and 

procedure, Advertising, Consumer 

information, Marketing agreements, 

Raspberry promotion, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, 7 CFR part 1208 is proposed 

to be amended as follows: 

PART 1208—PROCESSED 

RASPBERRY PROMOTION, 

RESEARCH, AND INFORMATION 

ORDER 

■ 1. The authority citation for 7 CFR 

part 1208 continues to read as follows: 

Authority: 7 U.S.C. 7411–7425; 7 U.S.C. 

7401. 

■ 2. Section 1208.3 is revised to read as 

follows: 

§ 1208.3 Crop year. 

Crop year means the 12-month period 

from October 1 through September 30 or 

such other period approved by the 

Secretary. 

■ 3. Section 1208.7 is revised to read as 

follows: 

§ 1208.7 Fiscal period. 

Fiscal period means the 12-month 

period from October 1 through 

September 30 or such other period as 

approved by the Secretary. 

■ 4. Section 1208.78 is revised to read 

as follows: 

§ 1208.78 OMB control numbers. 

The control numbers assigned to the 

information collection requirements by 

the Office of Management and Budget 

pursuant to the Paperwork Reduction 

Act of 1995, 44 U.S.C. Chapter 35, are 

OMB control number 0505–0001, and 

OMB control number 0581–0093. 

■ 5. Section 1208.108 is revised to read 

as follows: 

§ 1208.108 OMB control number. 

The control number assigned to the 

information collection requirement in 

this subpart by the Office of 

Management and Budget pursuant to the 

Paperwork Reduction Act of 1995, 44 

U.S.C. Chapter 35, is OMB control 

number 0581–0093. 

■ 6. Subpart C—Rules and Regulations 

is added to read as follows: 

Subpart C—Rules and Regulations 

§ 1208.520 Late payment and interest 

charges for past due assessments. 

(1) A late payment charge shall be 

imposed on any handler or importer 

who fails to make timely remittance to 

the Council of the total assessments for 

which such handler or importer is 

liable. The late payment will be 

imposed on any assessments not 

received within 30 calendar days of the 

date they are due. This one-time late 

payment charge shall be 10 percent of 

the assessments due before interest 

charges have accrued. 

(2) In addition to the late payment 

charge, 1 percent per month interest on 

the outstanding balance, including any 

late payment and accrued interest, will 

be added to any accounts for which 

payment has not been received by the 

Council within 30 calendar days after 

the date the assessments are due. Such 

interest will continue to accrue monthly 

until the outstanding balance is paid to 

the Council. 

Dated: November 5, 2014. 

Rex A. Barnes, 

Associate Administrator. 

[FR Doc. 2014–26677 Filed 11–10–14; 8:45 am] 

BILLING CODE P 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing in 

this administrative order to reclassify 

rigid pedicle screw systems, a 


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67106 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 

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: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• 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, sergio.dedelcastillo@fda.hhs.gov. 

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 


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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 

§ 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 


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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). 

• 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. 

• 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 


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market after clearance of a premarket 

notification (510(k)) submission. 

• 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 § 888.3070 (21 

CFR 888.3070). DSSs are defined as 

systems that contain one or more nonuniform 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 § 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 § 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 § 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 


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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 § 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: 

• 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. 

• 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. 

• 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, postoperative wound problems including 

infection, and hematoma/seroma. 

• Adverse tissue reactions—Device 

material(s) may elicit adverse tissue 

reactions, such as foreign body 

response, metal allergy, and metal 

toxicity. 

• Device malposition—Risks of 

device malposition may include 

difficulty or inability to implant the 

device components or incorrect 

placement of the device. 

• 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 § 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 


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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: 

• The design characteristics of the 

device, including engineering 

schematics, must ensure that the 

geometry and material composition are 

consistent with the intended use. 

• Non-clinical performance testing 

must demonstrate the mechanical 

function and durability of the implant. 

• Device components must be 

demonstrated to be biocompatible. 

• Validation testing must demonstrate 

the cleanliness and sterility of, or the 

ability to clean and sterilize, the device 

components and device-specific 

instruments. 

• Labeling must specifically include 

the following: 

Æ A clear description of the 

technological features of the device 

including identification of device 

materials and the principles of device 

operation; 

Æ intended use and indications for 

use including levels of fixation; 

Æ identification of magnetic 

resonance compatibility status; 

Æ cleaning and sterilization 

instructions for devices and instruments 

that are provided non-sterile to the end 

user; and 

Æ 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 § 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 


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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 § 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 

§ 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 § 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 

§ 888.3070(a)(2)) 

A. Identification 

DSSs are a subset of the pedicle screw 

spinal systems regulated under 

§ 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 nonmetallic 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 


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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 

§ 860.7(c)(1)). Valid scientific evidence 

is ‘‘evidence from well-controlled 

investigations, partially controlled 

studies, studies and objective trials 

without matched controls, welldocumented 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 

§ 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 § 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 § 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. 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
67114 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 

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 

■ 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. 

■ 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: 

§ 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 devicespecific 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 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Proposed Rules 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 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 924 

[SATS No. MS–024–FOR; Docket No. 

OSMRE–2014–0005; S1D1SS S08011000 

SX066A00067F144S180110; S2D2SS 

S08011000SX066A00033F14XS501520] 

Mississippi Abandoned Mine Land 

Plan 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSMRE), are announcing receipt of a 

proposed amendment to the Mississippi 

Abandoned Mine Land Reclamation 

(AMLR) Plan (hereinafter, the 

Mississippi Plan) under the Surface 

Mining Control and Reclamation Act of 

1977 (SMCRA or the Act). Mississippi 

has requested concurrence from the 

Secretary of the Department of the 

Interior with its certification of 

completion of all coal-related 

reclamation objectives. If the Secretary 

concurs with the certification, 

Mississippi intends to request AMLR 

funds to pursue projects in accordance 

with section 411 of SMCRA. 

This document gives the times and 

locations that the Mississippi Plan and 

this proposed amendment to that plan 

are available for your inspection, the 

comment period during which you may 

submit written comments on the 

amendment, and the procedures that we 

will follow for the public hearing, if one 

is requested. 

DATES: We will accept written 

comments on this amendment until 4:00 

p.m., c.d.t., December 12, 2014. If 

requested, we will hold a public hearing 

on the amendment on December 8, 

2014. We will accept requests to speak 

at a hearing until 4:00 p.m., c.d.t. on 

November 28, 2014. 

ADDRESSES: You may submit comments, 

identified by SATS No. MS–024–FOR, 

by any of the following methods: 

• Mail/Hand Delivery: Sherry Wilson, 

Director, Birmingham Field Office, 

Office of Surface Mining Reclamation 

and Enforcement, 135 Gemini Circle, 

Suite 215, Homewood, Alabama 35209; 

Telephone: (205) 290–7282. 

• Fax: (205) 290–7280. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Comment Procedures’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

review copies of the Mississippi Plan, a 

listing of any scheduled public hearings, 

and all written comments received in 

response to this document, you must go 

to the address of our Birmingham Field 

Office listed above during normal 

business hours, Monday through Friday, 

excluding holidays. You may receive 

one free copy of the amendment by 

contacting OSMRE’s Birmingham Field 

Office or going to www.regulations.gov. 

Sherry Wilson, Director, Birmingham 

Field Office, Office of Surface Mining 

Reclamation and Enforcement, 135 

Gemini Circle, Suite 215, Homewood, 

Alabama 35209, Telephone: (205) 290– 

7282, Email: swilson@osmre.gov. 

In addition, you may review a copy of 

the amendment during regular business 

hours at the following location: 

Mississippi Office of Geology, 

Department of Environmental Quality, 

700 N. State Street Jackson, Mississippi 

39202, Telephone: (601) 961–5519. 

FOR FURTHER INFORMATION CONTACT: 

Sherry Wilson, Director, Birmingham 

Field Office. Telephone: (205) 290– 

7282. Email: swilson@osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on Mississippi Plan 

II. Description of the Proposed Amendment 

III. Public Comment Procedures 

IV. Procedural Determinations 

I. Background on the Mississippi Plan 

The Abandoned Mine Land 

Reclamation Program was established 

by Title IV of the Act, (30 U.S.C. 1201 

et seq.) in response to concerns over 

extensive environmental damage caused 

by past coal mining activities. The 

program is funded by a reclamation fee 

collected on each ton of coal that is 

produced. The money collected is used 

to finance the reclamation of abandoned 

coal mines and for other authorized 

activities. Section 405 of the Act allows 

States and Indian tribes to assume 

exclusive responsibility for reclamation 

activity within the State or on Indian 

lands if they develop and submit to the 

Secretary of the Interior for approval, a 

program (often referred to as a plan) for 

the reclamation of abandoned coal 

mines. On September 27, 2007, the 

Secretary of the Interior approved the 

Mississippi plan. You can find 

background information on the 

Mississippi Plan, including the 

Secretary’s findings, the disposition of 

comments, and the approval of the plan 

in the September 27, 2007, Federal 

Register (72 FR 54832). No amendments 

have previously been made to the 

Mississippi Plan. 

II. Description of the Proposed 

Mississippi Amendment 

By letter dated August 11, 2014 

(Administrative Record No. MS–0424), 

Mississippi indicated to OSMRE that it 

has instituted the necessary processes to 

reclaim the remaining coal related 

problems within the State. As such, 

Mississippi seeks certification of 

completion of all coal-related problems. 

If this request is approved by OSMRE, 

it will mark the addressing, for the 

present, of all known existing coalrelated problems within the State that 

are eligible for funding under 

Mississippi’s AMLR Program. 

If approved, the certificate of 

completion will be codified at 30 CFR 

924.25. In accordance with 30 CFR 

875.13(c), Mississippi may then 

implement a program under Section 411 

of SMCRA. 

OSMRE is seeking public comment on 

the adequacy of Mississippi’s 

certification that it has addressed all 

reclamation relating to abandoned coal 

mine lands. In addition, OSMRE is 

aware of the potential for problems to 

occur in the future related to pre-August 

3, 1977, coal mining. In accordance with 

30 CFR 875.13(a)(3), Mississippi agrees 

to acknowledge and give top priority to 

any coal-related problem(s) that may be 

found or occur after submission of the 

certificate of completion. 

The full text of the plan amendment 

is available for you to read at the 

locations listed above under ADDRESSES

or at www.regulations.gov. 

III. Public Comment Procedures 

Under the provisions of 30 CFR 

884.15(a), we are seeking your 

comments on whether Mississippi’s 

proposed amendment satisfies the 

applicable reclamation plan approval 

criteria of 30 CFR 884.14. If we approve 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS