[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