[Federal Register Volume 69, Number 248 (Tuesday, December 28, 2004)]
[Rules and Regulations]
[Pages 77621-77623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. 1998N-1111]
Gastroenterology-Urology Devices; Classification for External
Penile Rigidity Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying external
penile rigidity devices intended to create or maintain sufficient
penile rigidity for sexual intercourse into class II (special
controls). FDA also is exempting these devices from premarket
notification requirements. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the guidance document
that will serve as the special control for the device.
DATES: This rule is effective January 27, 2005.
FOR FURTHER INFORMATION CONTACT: Janine Morris, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.) as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(Public Law 101-629), the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Public Law 105-115), and the Medical Device User
Fee and Modernization Act of 2002 (Public Law 107-250), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on 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 act, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the agency takes the following steps: (1) Receives
a recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the act into
class III without any FDA rulemaking process. These devices remain in
class III and require premarket approval, unless and until FDA
initiates the following procedures: (1) FDA reclassifies the device
into class I or II; (2) FDA issues an order classifying the device into
class I or II in accordance with new section 513(f)(2) of the act, as
amended by FDAMA; or (3) FDA issues an order finding the device to be
substantially equivalent, under section 513(i) of the act, to a
predicate device that does not require premarket approval.
The agency determines whether new devices are substantially
equivalent to
[[Page 77622]]
predicate devices by means of the premarket notification procedures in
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
Consistent with the act and the regulations, FDA consulted with the
Gastroenterology and Urology Devices Panel (the panel), an FDA advisory
committee, regarding the classification of this device.
FDAMA added a new section 510(m) to the act (21 U.S.C. 360(m)). New
section 510(m) of the act provides that a class II device may be
exempted from the premarket notification requirements under section
510(k) of the act, if the agency determines that premarket notification
is not necessary to assure the safety and effectiveness of the device.
FDA has determined that premarket notification is not necessary to
assure the safety and effectiveness of external penile rigidity
devices.
FDA believes that for devices of a type generally exempt from
premarket notification, certain modifications to these devices may
change the intended use of these devices to an intended use that is of
substantial importance in preventing impairment of human health, or may
cause these devices to present unreasonable risks of illness or injury.
Accordingly, devices changed in this manner would require premarket
notification. For example, FDA considers a class II device to be
subject to premarket notification requirements if the device operates
using a different fundamental scientific technology than that used by a
legally marketed device in that generic type.
II. Regulatory History of the Device
In the Federal Register of March 17, 2004 (69 FR 12598), FDA
proposed to classify external penile rigidity devices intended to
create or maintain sufficient penile rigidity for sexual intercourse
into class II (special controls). FDA also proposed to exempt the
devices from premarket notification requirements. Also in the Federal
Register of March 17, 2004 (69 FR 26398), FDA announced the
availability of a draft guidance document that FDA intended to serve as
the special control for external penile rigidity devices. FDA invited
interested persons to comment on the draft guidance document and
invited comment on the proposed regulation by June 15, 2004. FDA
received no comments on the proposed rule or draft guidance.
III. Summary of Final Rule
In accordance with 21 CFR 860.84(g)(2), FDA is classifying external
penile rigidity devices into class II (special controls). FDA is
codifying the classification of external penile rigidity devices by
adding Sec. 876.5020. The agency is also exempting these devices from
premarket notification requirements. The guidance document entitled
``Class II Special Controls Guidance Document: External Penile Rigidity
Devices'' will serve as the special control for external penile
rigidity devices. Following the effective date of the final
classification rule, manufacturers will need to address the issues
covered in this special control guidance. However, the manufacturer
need only show that its device meets the recommendations of the
guidance or in some other way provides equivalent assurances of safety
and effectiveness. For the convenience of the reader, in part 876 (21
CFR part 876) FDA is also adding Sec. 876.1(e) to inform the reader
where to find guidance documents referenced in that part.
IV. Analysis of Comments and FDA's Response
FDA received no comments on the proposed rule. Therefore, under
section 513 of the act, FDA is adopting the summary of reasons for the
panel's recommendation and the summary of data upon which the panel's
recommendation is based. FDA is also adopting the assessment of the
risks to public health stated in the proposed rule published on March
17, 2004. FDA is issuing this final rule which classifies the generic
type of device, external penile rigidity devices, into class II
(special controls). In addition, FDA, on its own initiative, is
exempting external penile rigidity devices from premarket notification
requirements.
V. 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.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 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. This final rule will relieve a burden and simplify
marketing by exempting the devices from premarket notification
requirements. The guidance document is based on existing review
practices and will not impose new burdens on manufacturers of these
devices. The agency, therefore, certifies that this 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 million or more (adjusted annually for
inflation) in any 1 year. The current threshold after adjustment for
inflation is $110 million. FDA does not expect this final rule to
result in any 1-year expenditure that would meet or exceed this amount.
VII. Federalism
FDA has analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies conferring substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order. As a result, a
federalism summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
FDA concludes that this rule contains no collection of information
that is subject to review by the Office of Management and Budget under
the Paperwork Reduction Act of 1995.
IX. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may
be seen by
[[Page 77623]]
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Gastroenterology and Urology Devices Panel of the Medical
Devices Advisory Committee transcript, August 7, 1997.
2. Lewis J.H. et al., ``A Way to Help Your Patients Who Use
Vacuum Devices,'' Contemporary Urology, vol. 3, No. 12: 15-24, 1991.
3. Montague, D.K. et al., ``Clinical Guidelines Panel on
Erectile Dysfunction: Summary Report on the Treatment of Erectile
Dsyfunction,'' Journal of Urology, 156: 2007-2011, 1996.
4. NIH Consensus Statement, ``Impotence,'' National Institutes
of Health, vol. 10, No. 4, 1992.
List of Subjects in 21 CFR Part 876
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
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
1. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Section 876.1 is amended by adding paragraph (e) to read as
follows:
Sec. 876.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
3. Section 876.5020 is added to subpart F to read as follows:
Sec. 876.5020 External penile rigidity devices.
(a) Identification. External penile rigidity devices are devices
intended to create or maintain sufficient penile rigidity for sexual
intercourse. External penile rigidity devices include vacuum pumps,
constriction rings, and penile splints which are mechanical, powered,
or pneumatic devices.
(b) Classification. Class II (special controls). The devices are
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9. The
special control for these devices is the FDA guidance document entitled
``Class II Special Controls Guidance Document: External Penile Rigidity
Devices.'' See Sec. 876.1(e) for the availability of this guidance
document.
Dated: December 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28252 Filed 12-27-04; 8:45 am]
BILLING CODE 4160-01-S