Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 21237 

[FR Doc. 2011–8930 Filed 4–14–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 884 

[Docket No. FDA–2011–N–0118] 

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of the Hemorrhoid Prevention Pressure 

Wedge 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

hemorrhoid prevention pressure wedge 

into class II (special controls). The 

special controls will apply to the device 

in order to provide a reasonable 

assurance of safety and effectiveness of 

the device. A hemorrhoid prevention 

pressure wedge provides support to the 

perianal region during the labor and 

delivery process. 

DATES: This rule is effective May 16, 

2011. The classification was applicable 

on January 13, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Glenn Bell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. G112, Silver Spring, 

MD 20993–0002, 301–796–6531. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or 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 (21 

U.S.C.360c(i)), 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) of the regulations. 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

August 5, 2009, classifying the HemAvert Perianal Stabilizer into class III, 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

August 17, 2009, Plexus Biomedical, 

Inc., submitted a petition requesting 

classification of the Hem-Avert Perianal 

Stabilizer under section 513(f)(2) of the 

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II. (Ref. 1) 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name hemorrhoid prevention pressure 

wedge, and it is identified as a 

hemorrhoid prevention pressure wedge 

that provides mechanical support to the 

perianal region during the labor and 

delivery process. External mechanical 

support of the perianal region is 

intended to help prevent the occurrence 

of external hemorrhoids associated with 

vaginal childbirth. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the 

recommended measures to mitigate 

these risks. 

TABLE 1—HEALTH RISKS AND MITIGATIONS

Identified risk Mitigation measures 

Skin/tissue trauma (e.g., rectal and/or anal trauma, necrosis, thinning, abrasion, laceration to the perineum, vulvar hematoma, sloughing).Nonclinical Analysis and Testing. 

Clinical Information. 

Labeling. 

Device failure (e.g., material failure, slippage) ................................................................................................. Nonclinical Analysis and Testing. 

Labeling. 

Device failure—obstruction to the treatment area caused by inability to remove the instrument quickly ....... Device Description.

Labeling. 

Infection. ............................................................................................................................................................ Labeling. 

Adverse tissue reaction ..................................................................................................................................... Biocompatibility. 

Pain ................................................................................................................................................................... Nonclinical Analysis and Testing. 

Biocompatibility. 

FDA believes that the following 

special controls address the risks to 

health and provide reasonable assurance 

of the safety and effectiveness of the 

device: (1) The sale, distribution, and 

use of this device are restricted to 


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21238 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 

prescription use in accordance with 21 

CFR 801.109; (2) the labeling should 

include specific instructions regarding 

the proper placement and use of the 

device; (3) the device should be 

demonstrated to be biocompatible; (4) 

mechanical bench testing of material 

strength should demonstrate that the 

device will withstand forces 

encountered during use; and (5) safety 

and effectiveness data should 

demonstrate that the device prevents 

hemorrhoids in women undergoing 

spontaneous vaginal delivery, in 

addition to general controls. Therefore, 

on January 13, 2011 (corrected order 

sent to petitioner on February 1, 2011), 

FDA issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 884.5200. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for a hemorrhoid prevention 

pressure wedge will need to address the 

issues covered in the special controls. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the hemorrhoid prevention 

pressure wedge they intend to market. 

II. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of this 

device from class III to class II will 

relieve manufacturers of the device of 

the cost of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the Agency 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. (21 

U.S.C. 360k); See Medtronic v. Lohr, 518 

U.S. 470 (1996); Riegel v. Medtronic, 

Inc., 552 U.S. 312 (2008). The special 

controls established by this final rule 

create ‘‘requirements’’ to address each 

identified risk to health presented by 

these specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors may have flexibility in how 

they meet these requirements. Cf. 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–42 (9th Cir. 1997). 

V. Paperwork Reduction Act of 1995 

This final rule establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

32501–3520). The collections of 

information in part 807, regarding 

premarket notification submissions, 

have been approved under OMB control 

no. 0910–0120; the collections of 

information in 21 CFR part 801, 

regarding labeling, have been approved 

under OMB control no. 0910–0485. 

VI. References 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Plexus Biomedical, Inc., 

August 17, 2009. 

List of Subjects in 21 CFR Part 884 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 884 is 

amended as follows: 

PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 884 continues to read as follows: 

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

360j, 371. 

■ 2. Section 884.5200 is added to 

subpart F to read as follows: 

§ 884.5200 Hemorrhoid prevention 

pressure wedge. 

(a) Identification. A hemorrhoid 

prevention pressure wedge provides 

mechanical support to the perianal 

region during the labor and delivery 

process. External mechanical support of 

the perianal region is intended to help 

prevent the occurrence of external 

hemorrhoids associated with vaginal 

childbirth. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Rules and Regulations 21239 

(1) The sale, distribution, and use of 

this device are restricted to prescription 

use in accordance with § 801.109 of this 

chapter. 

(2) The labeling must include specific 

instructions regarding the proper 

placement and use of the device. 

(3) The device must be demonstrated 

to be biocompatible. 

(4) Mechanical bench testing of 

material strength must demonstrate that 

the device will withstand forces 

encountered during use. 

(5) Safety and effectiveness data must 

demonstrate that the device prevents 

hemorrhoids in women undergoing 

spontaneous vaginal delivery, in 

addition to general controls. 

Dated: April 11, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–9141 Filed 4–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

28 CFR Parts 0 and 51 

[CRT Docket No. 120; AG Order No. 3262– 

2011] 

Revision of Voting Rights Procedures 

AGENCY: Civil Rights Division, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Attorney General finds it 

necessary to revise the Department of 

Justice’s ‘‘Procedures for the 

Administration of section 5 of the 

Voting Rights Act of 1965.’’ The 

revisions are needed to clarify the scope 

of section 5 review based on recent 

amendments to section 5, make 

technical clarifications and updates, and 

provide better guidance to covered 

jurisdictions and interested members of 

the public concerning current 

Department practices. Proposed revised 

Procedures were published for comment 

on June 11, 2010, and a 60-day comment 

period was provided. 

DATES: The rule will be effective on 

April 15, 2011. 

FOR FURTHER INFORMATION CONTACT: T. 

Christian Herren, Jr., Chief, Voting 

Section, Civil Rights Division, United 

States Department of Justice, Room 

7254–NWB, 950 Pennsylvania Avenue, 

NW., Washington, DC 20530, or by 

telephone at (800) 253–3931. 

SUPPLEMENTARY INFORMATION: 

Discussion 

Section 5 of the Voting Rights Act of 

1965, as amended, 42 U.S.C. 1973c, 

requires certain jurisdictions (listed in 

the Appendix) to obtain ‘‘preclearance’’ 

from either the United States District 

Court for the District of Columbia or the 

United States Attorney General before 

implementing any new standard, 

practice, or procedure that affects 

voting. 

Procedures for the Attorney General’s 

Administration of section 5 were first 

published in 1971. Proposed Procedures 

were published for comment on May 28, 

1971 (36 FR 9781), and the final 

Procedures were published on 

September 10, 1971 (36 FR 18186). As 

a result of the Department’s experience 

under the 1971 Procedures, changes 

mandated by the 1975 Amendments to 

the Voting Rights Act, and 

interpretations of section 5 contained in 

judicial decisions, proposed revised 

Procedures were published for comment 

on March 21, 1980 (45 FR 18890), and 

final revised Procedures were published 

on January 5, 1981 (46 FR 870) 

(corrected at 46 FR 9571, Jan. 29, 1981). 

As a result of further experience under 

the 1981 Procedures, specifically with 

respect to redistricting plans adopted 

following the 1980 Census, changes 

mandated by the 1982 Amendments to 

the Voting Rights Act, and judicial 

decisions in cases involving section 5, 

revised Procedures were published for 

comment on May 6, 1985 (50 FR 19122), 

and final revised Procedures were 

published on January 6, 1987 (52 FR 

486). 

In the twenty-four years since the 

previous revisions became final, the 

Attorney General has had further 

experience in the consideration of 

voting changes; the courts have issued 

a number of important decisions in 

cases involving section 5, and Congress 

enacted the 2006 amendments to the 

Voting Rights Act. This new revision 

reflects these developments. 

Comments 

In response to the Notice of Proposed 

Rulemaking (‘‘Notice’’) published on 

June 11, 2010 (75 FR 33205), we 

received comments from or on behalf of 

two national public interest 

organizations, one research and 

educational institution, one national 

political organization composed of 

attorneys, and one individual. All 

comments received are available for 

inspection and copying at 

www.regulations.gov and at the Voting 

Section, Civil Rights Division, 

Department of Justice, Washington DC 

20530. 

The comments received expressed 

diverse views and were of great 

assistance in the preparation of these 

final revisions to the Procedures. The 

final revised Procedures reflect our 

consideration of the comments as well 

as further consideration of sections or 

topics that were not the subject of 

comments. 

Section 51.2 Definitions 

The purpose of the revision to the 

definition of ‘‘change affecting voting’’ or 

‘‘change’’ is to clarify the definition of 

the benchmark standard, practice, or 

procedure. One commenter 

recommended we revise this section to 

reflect that the benchmark is the 

standard, practice, or procedure in force 

or effect at the time of the submission 

or the last legally enforceable standard, 

practice, or procedure in force or effect 

in the jurisdiction. We have concluded 

that no further revision of this section 

is warranted. The Voting Section’s 

practice is to compare the proposed 

standard, practice, or procedure to the 

benchmark. Generally, the benchmark is 

the standard, practice, or procedure that 

has been: (1) Unchanged since the 

jurisdiction’s coverage date; or (2) if 

changed since that date, found to 

comply with section 5 and ‘‘in force or 

effect.’’ Riley v. Kennedy, 553 U.S. 406, 

421 (2008); Procedures for the 

Administration of Section 5 of the 

Voting Rights Act of 1965, 28 CFR 

51.54. Where there is an unsubmitted 

intervening change, the Attorney 

General will make no determination 

concerning the submitted change 

because of the prior unsubmitted 

change. In such instances, it is our 

practice to inform the jurisdiction there 

is a prior related change that has not 

been submitted and that simultaneous 

review is required. A standard, practice, 

or procedure that has been reviewed 

and determined to meet section 5 

standards is considered to be in force or 

effect, even if the jurisdiction never 

implements the change because the 

change is effective as a matter of federal 

law and was available for use. 

Section 51.3 Delegation of Authority 

The purpose of the revisions to the 

delegation of authority is to make 

technical corrections to the delegation 

of authority from the Attorney General 

to the Assistant Attorney General, and 

from the Chief of the Voting Section to 

supervisory attorneys within the Voting 

Section, and to conform the Procedures 

to other parts of Title 28. Two 

commenters objected to the revisions, 

expressing concern that the delegation 

of the functions of the Chief to 

supervisory attorneys in the Voting 

Section results in the delegation of 

section 5 legal review authority to nonpolitically appointed attorneys 

subordinate to the Section Chief. 


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