[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37064-37066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93P-0355]


Gastroenterology-Urology Devices; Denial of Request for Change in 
Classification of the Ostomy Pouch and Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; denial of petition.

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SUMMARY: The Food and Drug Administration (FDA) is denying the petition 
submitted by Abraham L. Lastnik (hereinafter referred to as the 
petitioner) to reclassify the ostomy pouch and accessories from class I 
into class II. The agency is denying the petition because there is no 
new information, in the form of valid scientific evidence, that general 
controls currently used in the production of these devices are not 
sufficient to assure the safety and effectiveness of the devices. This 
notice also summarizes the basis for the agency's decision.

EFFECTIVE DATE: July 10, 1997.

FOR FURTHER INFORMATION CONTACT: Lillian L. Yin, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-5072.

SUPPLEMENTARY INFORMATION:

I. Classification and Reclassification of Devices Under the Medical 
Device Amendments of 1976

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c), as amended by the Medical Device Amendments of 
1976 (the amendments) (Pub. L. 94-295), FDA must classify devices into 
one of three regulatory classes: Class I, class II, or class III. FDA's 
classification of a device is determined by the amount of regulation 
necessary to provide reasonable assurance of the safety and 
effectiveness of a device. Except as provided in section 520(c) of the 
act (21 U.S.C. 360j(c)), FDA may not use confidential information 
concerning a device's safety and effectiveness as a basis for 
reclassification of the device from class III into class II or class I.
    Under the amendments, devices were classified into class I (general 
controls) if there was information showing that the general controls of 
the act were sufficient to provide reasonable assurance of safety and 
effectiveness; into class II (performance standards) if general 
controls were insufficient to provide reasonable assurance of safety 
and effectiveness, but there was sufficient information to establish a 
performance standard that would provide such assurance; and into class 
III (premarket approval) if there was insufficient information to 
support placing a device into class I or class II, and the device was a 
life-sustaining or life-supporting device or was for a use that is of 
substantial importance in preventing impairment of human health, or if 
the device presented a potential unreasonable risk of illness or 
injury.
    FDA has classified most generic types of devices that were on the 
market before the date of the amendments (May 28, 1976) (generally 
referred to as preamendments devices) under the procedures set forth in 
section 513(c) and (d) of the act through the issue of classification 
regulations into one of these three regulatory classes. Under section 
513(c) and (d) of the act, FDA secures expert Panel recommendations on 
initial device classifications for generic types of devices. FDA then 
considers the Panel's recommendations and, through notice and comment 
rulemaking, issues classification regulations.
    Devices introduced into interstate commerce for the first time 
after May 28, 1976, are by statute automatically classified into class 
III under section 513(f) of the act. These devices may be reclassified 
through the premarket notification process under section 510(k) of the 
act (21 U.S.C. 360(k)). Those devices that FDA finds to be 
substantially equivalent to a class I or II generic type of device are 
thereby classified in the same class as the predicate device.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. Section 513(e) of the act provides that FDA 
may, by rulemaking, reclassify a device (in a proceeding that parallels 
the initial classification proceeding) based on ``new information.'' 
The reclassification can be initiated by FDA or by the petition of an 
interested person.
    The term ``new information,'' as used in section 513(e) of the act, 
includes information developed as a result of a reevaluation of the 
data before the agency when a device was originally classified, as well 
as information not

[[Page 37065]]

presented, not available, or not developed at that time. (See, e.g., 
Holland Rantos v. United States Department of Health, Education, and 
Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 
F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 
1966).)
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of changes in ``medical science.'' (See 
Upjohn v. Finch, supra, 422 F.2d at 951.) However, regardless of 
whether data before the agency are old or new data, the ``new 
information'' on which any reclassification is based is required to 
consist of ``valid scientific evidence,'' as defined in section 
513(a)(3) of the act and 21 CFR 860.7(c)(2). FDA relies upon ``valid 
scientific evidence'' in the classification process to determine the 
level of regulation for devices. For the purpose of reclassification, 
the valid scientific evidence upon which the agency relies must be 
publicly available in accordance with section 520(c) of the act. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of premarket 
approval applications.

II. Reclassification Under the Safe Medical Devices Act of 1990

    The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) 
further amended the act to change the definition of a class II device. 
Under the SMDA, class II devices are those devices for which there is 
insufficient information to show that general controls themselves will 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide such 
assurance, including the issuance of a performance standard or other 
special controls, such as postmarket surveillance, patient registries, 
guidelines, and other appropriate actions necessary to provide such 
assurance of the device. Thus, the definition of a class II device was 
changed from ``performance standards'' to ``special controls.''

III. Background

    In the Federal Register of November 23, 1983 (48 FR 53012 at 
53023), FDA issued a final rule classifying the ostomy pouch and 
accessories into class I (Sec. 876.5900 (21 CFR 876.5900)). Section 
876.5900 describes the device as follows:
    An ostomy pouch and accessories is a device that consists of a 
bag that is attached to the patient's skin by an adhesive material 
and that is intended for use as a receptacle for collection of fecal 
material or urine following an ileostomy, colostomy, or ureterostomy 
(a surgically created opening of the small intestine, large 
intestine, or the ureter on the surface of the body). This generic 
type of device and its accessories includes the ostomy pouch, ostomy 
adhesive, the disposable colostomy appliance, ostomy collector, 
colostomy pouch, urinary ileostomy bag, urine collecting 
ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, 
ostomy protector, and the ostomy size selector, but excludes ostomy 
pouches which incorporate arsenic-containing compounds.
    In the Federal Register of January 23, 1981 (46 FR 7633), the 
agency had initially proposed that the devices be classified into class 
II. The proposal stated that the devices were reviewed by the 
Gastroenterological/Urological Device Classification Panel, the General 
Hospital and Personal Use Device Classification Panel, and the General 
and Plastic Surgery Device Classification Panel. Although the latter 
two Panels recommended classification of the ostomy pouch and 
accessories into class I, the agency agreed with the 
Gastroenterological/Urological Device Classification Panel 
recommendation to classify the devices into class II, and proposed 
classification accordingly. The Panels' recommendations, among other 
things, addressed the issues of allergenic materials, inadequate fit 
allowing liquid feces to contact skin, and malposition or slipping of 
the appliance with pressure against a protruding stoma. In addition, 
the Panels determined that the device is not an implant nor is it life 
sustaining or life supporting.
    The agency received one comment on the proposed classification of 
the ostomy pouch and accessories. The comment effectively refuted the 
arguments used by the Gastroenterological/Urological Device 
Classification Panel in recommending the devices be classified into 
class II, and the comment suggested that the devices be classified into 
class I, instead. In response to the comment, based upon the best 
information available at that time, and based upon the original 
recommendations of the General Hospital and Personal Use Device 
Classification Panel and the General and Plastic Surgery Device 
Classification Panel, the agency determined to place ostomy devices 
into class I.
    In the Federal Register of June 12, 1989 (54 FR 25042), the agency 
exempted the ostomy pouch and accessories from the requirements of 
premarket notification, determining that ``the manufacturer's 
submissions of premarket notifications are unnecessary for the 
protection of the public health and that review of such notifications 
by the agency will not advance FDA's public health mission.'' Though 
the ostomy pouch and accessories were exempted from premarket 
notification, they were not exempted from the requirements of the 
current good manufacturing practice regulations of 21 CFR part 820 or 
other general adulteration or misbranding petitions.
    Subsequently, the agency received a petition dated August 30, 1993, 
submitted by the petitioner requesting that the ostomy pouches and 
accessories be reclassified into class II.

IV. Agency Decision

    The petition stated that it was inappropriate for the agency to 
classify the devices into class I based, in part, on a single comment 
submitted by a manufacturer of ostomy accessories, because the 
manufacturer did not have sufficient information regarding the 
magnitude or frequency of device related problems. Furthermore, the 
petitioner states that, ``because ostomy prostheses are in constant 
contact with tissues that are normally retained within the body cavity, 
they would be expected to present the same risks * * * as [device] 
implants.'' These risks include adverse tissue reaction, problems with 
inadequate fit or improper size, and the potential for toxic systemic 
effects. The petitioner also claims that the issuance of voluntary and 
mandatory standards by certain foreign countries evidences the need for 
performance standards, and that there is sufficient information 
available to issue such performance standards. The petition asserts 
that classification into class II and performance standards would 
eliminate or reduce risks and shortcomings associated with these 
devices.
     FDA recognizes that section 513(e) of the act provides that for a 
preamendments device for which reclassification is sought, FDA may 
secure a recommendation concerning the reclassification from the Panel, 
which had made a recommendation on the initial classification of the 
device. FDA did not, however, refer this petition to the Panel because 
the petitioner did not present new information to warrant 
reconsideration of these devices by a Panel.
    Based on its review of the information contained in the petition, 
the agency finds that the petition raises the same issues previously 
evaluated by the device classification Panels and FDA when issuing the 
1989 final rule classifying ostomy pouches and accessories into class 
I. The petitioner

[[Page 37066]]

provided no new information that supports his assertion that the risks 
posed by these devices are of a magnitude or frequency that is 
different than those considered by FDA in 1989 in classifying these 
devices into class I. Moreover, the agency searched its Medical Device 
Reporting (MDR) data bases in order to ascertain the extent of reported 
problems or adverse incidents associated with these types of devices. 
The search for reported events during the period from 1985 to 1997 
revealed that not only are the rates of reported problems extremely 
low, but that the problems are the same type previously reported and 
considered by FDA and the Panels.
    Accordingly, FDA believes, on the basis of the same information 
considered and the same reasons stated in the 1989 classification 
regulation, as well as the examination of MDR reports for these devices 
from 1985 to 1997, that the risks to the public health posed by these 
devices are low and that class I provides a reasonable assurance of the 
safety and effectiveness of these devices.
    Furthermore, FDA does not agree with the petitioner's claim that 
the issuance of voluntary and mandatory standards by certain foreign 
countries evidences the need for a designation of class II with 
performance standards. The existence of performance standards in other 
countries for a certain device is not the statutory criterion under the 
act for the issuance of mandatory performance standards, or a 
designation of class II.
    Under section 513(a)(1)(B) of the act, a device is to be classified 
in class II if it is a device that cannot be classified as a class I 
device because the general controls by themselves are insufficient to 
provide reasonable assurance of the safety and effectiveness of the 
device, and for which there is sufficient information to establish 
special controls to provide such assurance. Therefore, the relevant 
inquiry to determine whether a device should be classified as class II 
and be subject to performance standards, is not whether there could be 
performance standards but whether class I controls are insufficient to 
provide reasonable assurance of the safety and effectiveness of the 
device.
    On the basis of information described above concerning the risks 
associated with ostomy pouches and accessories, FDA believes that these 
devices are appropriately in class I because general controls are 
sufficient to provide reasonable assurance of the safety and 
effectiveness of these devices.
    The petitioner presented insufficient new information, in the form 
of valid scientific evidence, to determine that special controls 
described in section 513(a)(1)(B) of the act, in addition to the 
general controls applicable to all devices, are necessary to provide 
reasonable assurance of the device's safety and effectiveness for its 
intended use. FDA, therefore, is denying the petition.

    Dated: June 27, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-17972 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F