Document ID: FDA-2011-N-0118-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Obstetrical and Gynecological Devices: Classification of the Hemorrhoid Prevention Pressure Wedge
Posted Date: 2011-04-15T04:00Z

[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Rules and Regulations]
[Pages 21237-21239]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9141]

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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.

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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 Hem-Avert 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      Nonclinical Analysis and Testing.
 trauma, necrosis, thinning, abrasion,            Clinical Information.
 laceration to the perineum, vulvar hematoma,     Labeling.
 sloughing).
Device failure (e.g., material failure,           Nonclinical Analysis and Testing.
 slippage).                                       Labeling.
Device failure--obstruction to the treatment      Device Description.
 area caused by inability to remove the           Labeling.
 instrument quickly.
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

[[Page 21238]]

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 Sec.  
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

0
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.

0
2. Section 884.5200 is added to subpart F to read as follows:

Sec.  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:

[[Page 21239]]

    (1) The sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec.  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