[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32061]


[[Page Unknown]]

[Federal Register: December 29, 1994]


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


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 884

[Docket No. 89N-0507]

 

Obstetrical and Gynecological Devices; Classification of Glans 
Sheaths

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
classifying glans sheath devices (previously known as ``short condoms'' 
or ``glans condoms'') into class III (premarket approval). The agency 
is also responding to comments received on the proposed regulation to 
classify such devices into class III (57 FR 12908, September 17, 1992). 
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 
1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).

EFFECTIVE DATE: January 30, 1995.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION:

I. Background

    The act, as amended by the 1976 amendments (Pub. L. 94-295) and the 
SMDA (Pub. L. 101-629), requires FDA to classify all devices intended 
for human use into 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. The effect of classifying a device that was delivered for 
introduction into interstate commerce prior to May 28, 1976, the 
enactment date of the 1976 amendments (preamendments device), into 
class III is to require each manufacturer of the device to submit to 
FDA a premarket approval application (PMA) or a notice of completion of 
a product development protocol (PDP) that includes information 
concerning the device's safety and effectiveness, after the publication 
under section 515(b) of the act (21 U.S.C. 360e(b)) of a final rule 
specifying the date by which a PMA or completed PDP must be filed with 
FDA.
    In the Federal Register of April 3, 1979 (44 FR 19894), FDA 
published a proposed regulation to classify preamendments obstetrical 
and gynecological devices, including a proposal to classify the condom 
into class II (44 FR 19957). In the Federal Register of February 26, 
1980 (45 FR 12710), FDA published a final rule classifying the condom 
into class II as a part of its final classification regulations for 
obstetrical and gynecological devices. As codified in Sec. 884.5300 (21 
CFR 884.5300), the condom is identified as a ``sheath which completely 
covers the penis with a closely fitting membrane'' for contraceptive, 
prophylactic (preventing transmission of venereal disease), and semen 
collection (for infertility diagnosis) purposes.
    Subsequently, at the March 7, 1989, open meeting of FDA's advisory 
committee, the Obstetrics-Gynecology Devices Panel (the Panel) reviewed 
all available information concerning the classification of short 
condomlike preamendments devices known as ``short condoms'' or ``glans 
condoms.'' Because ``short condom'' or ``glans condom'' devices do not 
cover the entire shaft of the penis nor provide a barrier protecting 
the shaft or foreskin of the penis against infection, and because there 
is no safety or effectiveness data for their prophylactic use, the 
Panel recommended to FDA, and FDA concurred, that the ``short condom'' 
or ``glans condom'' is not included in the regulation classifying 
condom devices (Sec. 884.5300).
    Accordingly, in the Federal Register of September 17, 1992 (57 FR 
42908), FDA published a proposed rule describing and identifying the 
glans cap device, distinguishing it from the condom device, as the 
generic category of devices that includes preamendments devices known 
as ``short condoms'' or ``glans condoms,'' and proposing to classify 
glans cap devices into class III. In the preamble to the September 17, 
1992, proposal, FDA provides a thorough discussion of the Panel's 
classification recommendations for glans cap devices, the reasons and 
summary data that were the basis for the Panel's recommendations and 
FDA's position regarding the Panel's recommendations.
    In promulgating the final classification regulation set forth in 
this final rule, FDA is changing the generic description of the devices 
classified under the regulation, from glans cap device to glans sheath 
device. See comment 1 below in this document and FDA's response.

II. Comments

    1. The Mentor Corp., Santa Barbara, CA, requested that FDA use a 
term other than ``glans cap'' to describe the generic group of devices 
classified in proposed Sec. 884.5320 because Glans Cap is the 
registered trademark name of one of a number of ``preamendments 
urosheath-type male external catheters'' marketed by the firm for urine 
collection. In August 1985 the product was renamed and registered under 
the trademark Glans Cap. It falls within the type of device 
classified by FDA into class I under 21 CFR 876.5250 as a type of urine 
collector and accessories device and is not the type of device 
described under Sec. 884.5320. Mentor Corp. further commented that the 
concerns that FDA expressed in the proposed rule about pregnancy/
infection risks and the absence of safety and effectiveness data for 
barrier contraceptive devices of the type described as a ``glans cap'' 
device have been reported in unfavorable articles using Mentor's 
trademark, Glans Cap. Noting the potential adverse impact 
such unfavorable publicity could have on Mentor's Glans Cap 
sales, the firm also requested that FDA clarify that the firm's 
catheter device is not the subject of the device classification under 
Sec. 884.5320 or the safety and effectiveness concerns discussed in the 
preamble to Sec. 884.5320.
    FDA concurs with Mentor Corp.'s concerns, and is changing the 
generic description of the devices classified under Sec. 884.5320 from 
``glans cap'' device to ``glans sheath'' device. FDA acknowledges that 
the category of devices, previously proposed for classification under 
the generic description, ``glans cap'' device, and classified into 
class III in this final rule under the generic description, glans 
sheath device, does not include Mentor's Glans Cap external 
urinary catheter device. Furthermore, the agency concerns about 
pregnancy/ infection risks for glans sheath devices and the absence of 
test and clinical data regarding the safety and effectiveness of glans 
sheath devices are not applicable to Mentor's Glans Cap 
external urinary catheter device.
    2. One comment claimed the identification of the generic device in 
proposed Sec. 884.5320(a) is inaccurate because various designs and 
characteristics of different devices of this generic type are omitted. 
The comment maintained the identification section of the regulation 
would not include versions of glans sheath devices that only cover a 
portion of the glans penis, that do not cover the corona and frenulum, 
that employ medical grade adhesive material to facilitate adhesion, or 
that rely on pressure and constriction around the glans penis to avoid 
falling off. The comment suggested that Sec. 884.5320(a) be revised to 
read, ``* * * is a sheath which may be self-adhesive or non self-
adhesive, which covers only the glans, or portions thereof, and, may 
also cover,
 * * * the corona and frenulum * * *.'' (Additional language 
underscored.)
    FDA does not believe the identification section of the regulation, 
as worded in proposed Sec. 884.5320(a), excludes glans sheath devices 
that are held on in any specific manner or that only cover a portion of 
the glans penis. The agency has modified the wording to state that the 
device is a sheath that covers only the glans penis or part thereof and 
``may also cover the area in the immediate proximity thereof, the 
corona and frenulum,'' to clarify that the classification includes 
devices that cover only the glans penis as well as those that 
additionally cover the immediate proximity. FDA believes this 
definition is clearer. FDA notes, however, that in setting forth the 
scope of regulations classifying obstetrical and gynecological devices, 
including the regulation in this final rule, ``* * * The identification 
of a device in a (classification) regulation * * * is not a precise 
description of every device that is, or will be, subject to the 
regulation.'' See 21 CFR 884.1(b). Therefore, FDA notes that a device 
may fall within a particular classification, even if the device is not 
precisely described in a regulation.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this final 
classification 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.

IV. Analysis of Impacts

    An analysis of the economic effects of this regulation conducted 
under Executive Order 12291 was discussed in the proposed rule and the 
substance of that analysis has not changed. Executive Order 12291 has 
been superseded by Executive Order 12866.
    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the final rule would 
not impose any new requirements and 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. The agency believes that only a small number of 
firms will be affected by this rule. Therefore, the agency certifies 
that the final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.
    A copy of the threshold assessment supporting this determination 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.

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

    1. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. New Sec. 884.5320 is added to subpart F to read as follows:


Sec. 884.5320  Glans sheath.

    (a) Identification. A glans sheath device is a sheath which covers 
only the glans penis or part thereof and may also cover the area in the 
immediate proximity thereof, the corona and frenulum, but not the 
entire shaft of the penis. It is indicated only for the prevention of 
pregnancy and not for the prevention of sexually-transmitted diseases.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 884.3.

    Dated: December 15, 1994.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 94-32061 Filed 12-28-94; 8:45 am]
BILLING CODE 4160-01-F