[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Pages 59780-59782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28563]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99P-0895]


Gastroenterology-Urology Devices; Denial of Request for Change in 
Classification of Fiber Optic Light Sources

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 QED, Inc. (QED) to reclassify fiber optic light sources 
used as accessories to endoscopes from class II to class I. The agency 
is denying the petition because QED failed to provide any new 
information to establish that general controls would provide reasonable 
assurance of the safety and effectiveness of the device. This notice 
also summarizes the basis for the agency's decision. 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), the Safe Medical Devices Act of 1990 (the SMDA), and the 
FDA Modernization Act of 1997 (the FDAMA).

EFFECTIVE DATE: November 3, 1999.
FOR FURTHER INFORMATION CONTACT: Donald J. St. Pierre, Center for 
Devices and Radiological Health (HFZ-470), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2194.

SUPPLEMENTARY INFORMATION:

I. Classification and Reclassification of Devices Under the 1976 
Amendments

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), 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 control needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices under the 1976 amendments were class I (general 
controls), class II (performance standards), and class III (premarket 
approval). 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 section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendment devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act (21 U.S.C. 360c(f)) 
into class III without any FDA rulemaking process. Those devices remain 
in class III and require premarket approval, unless and until the 
device is reclassified into class I or II or FDA issues an order 
finding the device to be substantially equivalent, under section 513(i) 
of the act (21 U.S.C. 360c(i)), to a predicate device that does not 
require premarket approval. The agency determines whether new devices 
are substantially equivalent to previously marketed devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act (21 U.S.C. 360c(e)). This section 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 and 515(b)(2)(A)(iv) of the act (21 U.S.C. 
360e(b)(2)(A)(iv)), includes information developed as a result of a 
reevaluation of the data before the agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at the 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 newly available regulatory authority 
(see Bell v. Goddard, supra, 366F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382,389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Regardless of 
whether data before the agency are past or new data, the ``new 
information'' upon which reclassification under section 513(e) of the 
act is based must consist of ``valid scientific evidence,'' as defined 
in section 513(a)(3) of the act (21 U.S.C. 360c(a)(3)) 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. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application. (See section 520(c) of the act (21 
U.S.C. 360j(c)).

II. Reclassification Under the SMDA

    The SMDA (Public Law 101-629) further amended the act to change the 
definition of a class II device. Under the SMDA, class II devices are 
those devices which cannot be classified into class I because general 
controls by themselves are not sufficient to provide reasonable 
assurance of safety and effectiveness, but for which there is 
sufficient information to establish special controls to provide such 
assurance, including performance standards, postmarket surveillance, 
patient registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions the agency deems 
necessary (section 513(a)(1)(B) of the act (21 U.S.C. 360c(a)(1)(B)). 
Thus, the definition of the controls for a class II device was changed 
from ``performance standards'' to ``special controls.'' In order for a 
device to be reclassified from class II into class I, the agency must 
determine that special controls are not necessary to provide reasonable 
assurance of its safety and effectiveness.

III. Background

    In the Federal Register of November 23, 1983 (48 FR 53012 at 
53015), FDA issued a final rule classifying the endoscope and 
accessories, including fiber optic light sources, into class II (21 CFR 
876.1500). The preamble to the proposal (46 FR 7571, January 23, 1981) 
to classify the device included the recommendations of the 
Gastroenterology-Urology Device and the General and Plastic Surgery 
Device Classification Panels (the Panels). Both Panels' 
recommendations, among other things, identified certain risks to health 
(misdiagnosis and inappropriate

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therapy; infection; trauma, hemorrhage, or perforation; adverse tissue 
reaction; electrical injury because of improper design or construction; 
burns and rupture of body cavity, embolism and hypotensive shock) 
presented by the device. The agency agreed with both Panels' 
recommendations and proposed classification accordingly.
    The agency received one comment on the proposed classification of 
the endoscope and accessories. The comment suggested that the endoscope 
and its accessories be classified into class I rather than class II as 
proposed. The comment stated that the skill of the user is more 
essential to the safe use of the device than its design and 
construction. The agency partially agreed with the comment. The agency 
believed that the principal hazard associated with the use of the 
device may be due to unskilled users. However, the agency believed then 
and continues to believe that fiber optic light sources should be 
classified into class II because the electrical, optical, mechanical, 
biocompatibility, and lighting characteristics of the device must be 
controlled by special controls to prevent injury to the patient 
resulting from devices of improper design and construction.
    In the Federal Register of January 16, 1996 (61 FR 1117 at 1122), 
FDA issued a final rule reclassifying 111 generic types of class II 
devices into class I based on new information respecting such devices. 
FDA also exempted the 111 generic types of devices from the requirement 
of premarket notification, with limitations. Fourteen of the 111 
generic types of devices were endoscopes and accessories, but did not 
include fiber optic light sources.
    On December 11, 1998, the agency received a petition from QED, a 
consulting firm, requesting that the fiber optic light sources be 
reclassified from class II into class I.

IV. Device Description

     A fiber optic light source is an accessory device to an endoscope 
that provides illumination to allow observation of body cavities, 
hollow organs, and canals.

V. Agency Decision

    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 of the device 
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 this device by a Panel.
    The petition is requesting reclassification based, in part, on the 
European Union Medical Devices Directive 93/42 EEC (EU MDD), Annex IV, 
Classification III, Non-invasive Devices 1.1, Rule 1 and the FDA 
General Device Classification Questionnaire. According to the petition, 
the EU MDD would support down classifying these devices because it 
states that all noninvasive devices are class I unless particular 
exceptions apply and those exceptions are not relevant to the fiber 
optic light sources used as accessories for endoscopes. The petition 
also notes that the FDA questionnaire states that, ``if the device is 
not life supporting; is not a device for a use which is of substantial 
importance in preventing impairment of human health; does not present a 
potential unreasonable risk of illness or injury; and there is 
sufficient information to determine that general controls are 
sufficient to provide reasonable assurance of safety and effectiveness, 
then the device is class I.'' The petition implies that classification 
of the device into class I and the use of general controls are 
sufficient to provide reasonable assurance of safety and effectiveness.
    Based on its review of the information contained in the petition, 
the agency finds that the petition raises the same issues that were 
evaluated by the device classification Panels and by FDA when issuing 
the 1983 final rule classifying the endoscope and accessories, 
including fiber optic light sources, into class II. The petitioner 
provided no new information to supports its claim that the risks posed 
by this device are of the type for which general controls alone would 
provide reasonable assurance of the safety and effectiveness of the 
device. Nor did the petitioner provide new information justifying a 
change in the classification of fiber optic light sources.
    Furthermore, since the classification of this device, there have 
been technological advances in fiber optic light sources, i.e., many 
light sources are now software controlled. The petitioner provided no 
information as to how to control the risks associated with the software 
design. Additionally, at the time of the classification, 
electromagnetic compatibility (EMC) was not recognized as a risk to 
health. FDA now believes EMC should be considered a risk. Moreover, the 
agency searched its medical device reporting (MDR) data base in order 
to determine the extent of reported problems or adverse incidents 
associated with devices within this generic type. The search revealed 
several adverse events of the types considered by the Panels and FDA 
during and since the classification (Ref. 1). FDA believes that fiber 
optic light sources require special controls to eliminate or reduce the 
risks associated with them.
    Accordingly, FDA believes, on the basis of the information 
considered in the petition, and for the same reasons stated when the 
classification regulation issued, as well as on the basis of 
technological advances and the MDR reports, that the risks to public 
health posed by these devices continue and that class II is necessary 
to provide a reasonable assurance of the safety and effectiveness of 
this type of device. Assuming the petitioner has correctly interpreted 
the EU MDD, the classification of a device under the EU regulatory 
system does not describe or establish a similar level of control under 
the act.
    The petitioner's claim that ``light sources do not require special 
controls and are approved under the UL Safety Standards for Medical 
Devices, UL 2601'' does not support a reliance on general controls 
only; UL 2601 is the type of voluntary standard that would qualify as a 
special control. Similarly, the petitioner's claim that ``there is no 
potential hazard to the patient or the medical personnel'' because 
light sources conform to UL 2601 supports the agency's belief that 
electrical safety controls are needed for light sources.
    As stated previously, FDA's search of the MDR data base revealed 
adverse events relating to electrical safety, such as arcing resulting 
in a burn; unintentional shutdown of the light source, resulting in a 
procedural delay; and patient and drape burns related to light cable 
guides. These are the type of adverse events which special controls are 
intended to obviate.
    In further recognition of EMC and electrical safety risks, under 
the good guidance practices, FDA has developed a guidance document 
entitled ``510(k) Checklist for Endoscopic Light Sources Used in 
Gastroenterology and Urology,'' dated June 22, 1995. This checklist 
identifies the type of information a premarket notification should 
include to support a determination of substantial equivalence. The 
checklist also includes recommendations for EMC testing and electrical 
safety testing, including UL 2601 cited by the petitioner.
    Under section 513(a)(1)(A) of the act, a device is to be classified 
in class I if it is a device for which the general controls are 
sufficient to provide reasonable assurance of the safety and

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effectiveness of the device. Therefore, the relevant question is 
whether a device should be classified as class I and be subject only to 
general controls, or whether class II controls are necessary to provide 
reasonable assurance of the safety and effectiveness of the device. On 
the basis of information described previously concerning the risks 
associated with the fiber optic light sources, FDA believes that this 
device is appropriately in class II.
     The petitioner presented no new information, in the form of valid 
scientific evidence, on which FDA could rely to determine that general 
controls are sufficient to provide reasonable assurance of the safety 
and effectiveness of the device for its intended use. FDA, therefore, 
is denying the petition.

VI. Reference

    The following information has been placed on display in the Dockets 
Managements Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Food and Drug Administration, Center for Devices and 
Radiological Health, Medical Device Reporting Search Information, 5 
pp.

    Dated: September 9, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-28563 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F