[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Rules and Regulations]
[Pages 21237-21239]
From the Federal Register Online via the Government Publishing 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
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Identified risk Mitigation measures
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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.
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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