[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Rules and Regulations]
[Pages 4881-4882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2148]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 97N-0481]


Gastroenterology-Urology Devices: Reclassification of the Penile 
Rigidity Implant

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is reclassifying the 
penile rigidity implant from class III to class II when intended to 
provide penile rigidity in men diagnosed as having erectile 
dysfunction. The special control is the FDA guidance document entitled 
``Guidance for the Content of Premarket Notifications for Penile 
Rigidity Implants.'' This action is taken on FDA's own initiative based 
on new information. This action is being taken under the Federal Food, 
Drug, and Cosmetic Act (the act), as amended by the Medical Device 
Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA 
Modernization Act of 1997.

DATES:  This regulation is effective March 3, 2000.

FOR FURTHER INFORMATION CONTACT:  John H. Baxley, Center for Devices 
and Radiological Health (CDRH) (HFZ-470), Food and Drug Administration, 
9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 16, 1997 (62 FR 65770), FDA 
issued a proposed rule to reclassify the penile rigidity implant from 
class III to class II based on new information respecting such device. 
FDA identified the guidance document entitled ``Guidance for the 
Content of Premarket Notifications for Penile Rigidity Implants'' as 
the special control capable of providing reasonable assurance of safety 
and effectiveness for the device.
    Interested persons were given until March 16, 1998, to comment on 
the proposed rule. FDA received no comments on the proposed rule.

II. FDA's Conclusions

    Based on a review of a substantial number of published studies 
referenced in the preamble to the proposed rule and placed on file in 
FDA's Dockets Management Branch, FDA identified the following risks to 
health presented by the device: (1) Infection; (2) erosion, migration, 
and extrusion; (3) mechanical malfunction; (4) patient dissatisfaction; 
(5) adverse tissue reaction; (6) prolonged or intractable pain; (7) 
urinary obstruction; (8) silicone particle migration; and (9) other 
infrequently reported complications.
    In the preamble to the proposed rule, FDA also noted that there is 
reasonable knowledge of the benefits of the device. Specifically, 
placement of the penile rigidity implant in men with erectile 
dysfunction typically provides sufficient penile rigidity for sexual 
intercourse and satisfaction rates in excess of 90 percent have been 
reported among penile rigidity implant recipients.
    Based on its review of the cited studies, FDA determined that the 
guidance document would address adequately the risks to health 
discussed above by: (1) Labeling that would provide information to 
physicians and patients for the proper implantation and care of the 
device; (2) biocompatibility testing that would control the risk of 
adverse tissue reaction; (3) mechanical testing that would help control 
the risks of erosion, migration, extrusion, mechanical malfunction, and 
prolonged or intractable pain; (4) clinical data requirements for 
510(k)'s that would help determine whether the risks presented by the 
device are within the limits established by existing devices; and (5) 
sterilization procedures and labeling that would guard against the 
implantation of an unsterile device.
    FDA has concluded that special controls, in addition to general 
controls, would provide reasonable assurance of the safety and 
effectiveness of the device and that the FDA guidance document entitled 
``Guidance for the Content of Premarket Notifications for Penile 
Rigidity Implants'' is an adequate special control.

III. Electronic Access to Guidance Document

    In order to receive the guidance entitled ``Guidance for the 
Content of Premarket Notifications for Penile Rigidity Implants'' via 
your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. At the first 
voice prompt press 1 to access DSMA Facts, at second voice prompt press 
2, and then enter the document number (177) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes the draft guidance 
entitled ``Guidance for the Content of Premarket Notifications for 
Penile Rigidity Implants,'' device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or

[[Page 4882]]

cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

V. 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) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), 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 consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive Order and so is not 
subject to review 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. Reclassification of this device from class III to 
class II will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act (21 U.S.C. 360e). Because reclassification will reduce 
regulatory costs with respect to this device, it will impose no 
significant impact on any small entities and it may permit small 
potential competitors to enter the marketplace by lowering costs. The 
agency, therefore, certifies that the final rule will not have a 
significant economic impact on a substantial number of small entities. 
The rule also does not trigger the requirement for a written statement 
under section 202(a) of the Unfunded Mandates Reform Act because it 
does not impose a mandate that results in an expenditure of $100 
million or more by State, local, or tribal governments in the 
aggregate, or by the private sector, in any one year. Therefore, under 
the Regulatory Flexibility Act, no further analysis is required.

VI. Paperwork Reduction Act of 1995

    FDA has determined that this final rule does not contain any 
information collection requirements and, therefore, it is not subject 
to review by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995.

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 876.3630 is revised to read as follows:


Sec. 876.3630  Penile rigidity implant.

    (a) Identification. A penile rigidity implant is a device that 
consists of a pair of semi-rigid rods implanted in the corpora 
cavernosa of the penis to provide rigidity. It is intended to be used 
in men diagnosed as having erectile dysfunction.
    (b) Classification. Class II. The special control for this device 
is the FDA guidance entitled ``Guidance for the Content of Premarket 
Notifications for Penile Rigidity Implants.''

    Dated: January 16, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-2148 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F