[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Proposed Rules]
[Pages 42809-42813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 97P-0210]


Ear, Nose, and Throat Devices; Reclassification of Endolymphatic 
Shunt Tube With Valve

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the endolymphatic shunt tube with valve from class III to 
class II. The device is intended to be implanted in the inner ear to 
relieve the symptoms of vertigo and hearing loss due to endolymphatic 
hydrops (increase in endolymphatic fluid) of Meniere's disease. This 
reclassification is based upon new information regarding the device 
contained in a reclassification petition submitted by E. Benson Hood 
Laboratories, Inc. (Hood Laboratories). Elsewhere in this issue of the 
Federal Register, FDA is publishing a notice of availability of a draft 
guidance document that would serve as the special control if this 
proposal becomes final. FDA is taking this action 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 (SMDA), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA).

DATES: Submit written or electronic comments by November 13, 2001. See 
section XII for the proposed effective date of a final rule based on 
this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: James K. Kane, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory authorities)

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public 
Law 105-115), 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, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
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 preamendments 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: (1) The 
device is reclassified 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 (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 offered 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.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of classified preamendments devices is governed by 
section 513(e) of the act. This section provides that FDA may, by 
rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``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 the device was 
originally classified, as well as information not 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 newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.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'' to support reclassification under section 513(e) of 
the act 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). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. 
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. 
denied, 474 U.S. 1062 (1985)). 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., nonpublic information in a 
pending PMA. (See section 520c of the act (21 U.S.C. 360j(c).)

II. Regulatory History of the Device

    In the Federal Register of November 6, 1986 (51 FR40378), FDA 
issued a final rule classifying the endolymphatic shunt tube with valve 
into class III (21 CFR 874.3850). The preamble to the proposal to 
classify the device (47 FR 3280, January 22, 1982) included the

[[Page 42810]]

recommendation of the Ear, Nose, and Throat Devices Panel (the Panel) 
regarding the classification of the device, a summary of the reasons 
the device should be subject to premarket approval, and identification 
of certain risks to health presented by the device. The Panel also 
recommended under section 513(c)(2)(A) of the act that a high priority 
for the application of section 515 of the act be assigned to the 
endolymphatic shunt tube with valve.
    In the Federal Register of January 6, 1989 (54 FR 550), FDA 
published a notice of intent to initiate proceedings to require 
premarket approval of 31 preamendments class III devices assigned a 
high priority by FDA for application of premarket approval 
requirements. Among other things, the notice described the factors FDA 
takes into account in establishing priorities for initiating 
proceedings under section 515(b) of the act for issuing final rules 
requiring that preamendments class III devices have approved PMAs or 
declared completed product development protocol (PDPs). Using those 
factors, FDA determined that the endolymphatic shunt tube with valve, 
identified in Sec. 874.3850, had a high priority for initiating a 
proceeding to require premarket approval. Accordingly, FDA began a 
rulemaking to require that the endolymphatic shunt tube with valve have 
an approved PMA or a PDP that has been declared completed.
    In the Federal Register of May 4, 1990 (55 FR 18830), FDA issued a 
proposed rule to require the filing of a PMA or a notice of completion 
of a PDP for the endolymphatic shunt tube with valve. In accordance 
with section 515(b)(2)(A) of the act, the preamble to the proposal 
included the agency's proposed findings with respect to the degree of 
risk of illness or injury designed to be eliminated or reduced by 
requiring the device to meet the premarket approval requirements, and 
the benefits to the public from the use of the device. The proposal 
also provided an opportunity for interested persons to comment on the 
proposed rule and to request a change in the classification of the 
device based on new information relevant to its classification. The 
period for requesting a change in the classification of the device 
closed on May 21, 1990. The period for commenting on the proposed rule 
closed on July 3, 1990. FDA did not receive any comments on the 
proposed rule.
    On July 27, 1990, FDA received a petition from Hood Laboratories 
requesting a change in the classification of the endolymphatic shunt 
tube with valve from class III to class II. In response to requests 
from FDA for additional information, the Hood Laboratories petition was 
amended on April 8, 1991, and May 8, 1992, and filed on May 29, 1992. 
The Panel met on June 11, 1992, and recommended that the generic 
endolymphatic shunt tube with valve be reclassified from class III to 
class II. FDA disagreed with the Panel's recommendation. FDA found that 
the petition contained insufficient valid scientific evidence to 
determine that the controls described in section 513(a)(1)(B) of the 
act, in addition to the general controls applicable to all devices, 
would provide reasonable assurance of the device's safety and 
effectiveness for its intended use. In particular, FDA found that Hood 
Laboratories did not adequately address the issues of normal 
endolymphatic shunt pressure, the mode of action of the endolymphatic 
shunt tube with valve, flow characteristics, nor the risks associated 
with the use of the device. Accordingly, in the Federal Register of 
December 9, 1996 (61 FR 64909), FDA published a notice denying Hood 
Laboratories' petition to reclassify the endolymphatic shunt tube with 
valve from class III to class II.
    On May 27, 1997, Hood Laboratories submitted a second petition 
(Ref. 1) in accordance with section 513(e) of the act and Sec. 860.130 
(21 CFR 860.130(a)), based on new information. The petitioner again 
requested reclassification of the endolymphatic shunt tube with valve 
from class III to class II and provided new information that adequately 
addressed FDA's concerns. As discussed further below, the petitioner 
submitted additional information regarding the risks associated with 
the endolymphatic shunt tube with valve. The new information showed 
that risks such as incidences of infection and clogging have similar 
occurrences in the valved and nonvalved endolymphatic shunts. The 
nonvalved device was classified into class II in 1986.
    In accordance with section 513(e) of the act, Sec. 860.130, and 
based on new information submitted or otherwise available to the agency 
with respect to the device, FDA is proposing to reclassify this device 
from class III to class II when the device is intended to be implanted 
in the inner ear to relieve the symptoms of vertigo and hearing loss 
due to endolymphatic hydrops of Meniere's disease. Consistent with the 
act and the regulation, FDA did not refer the petition to the Panel for 
its recommendation on the requested change in classification.

III. Device Description

    The endolymphatic shunt tube with valve is a device that consists 
of a pressure-limiting valve associated with a tube intended to be 
implanted in the inner ear to relieve the symptoms of vertigo and 
hearing loss due to endolymphatic hydrops (increase in endolymphatic 
fluid) of Meniere's disease. The device directs excess endolymph (the 
fluid contained in the membranous labyrinth of the ear) from the 
distended (enlarged or swollen) end of the endolymphatic system into 
the mastoid cavity (area of the temporal bone behind the ear) where 
reabsorption of the fluid occurs. The function of the pressure-limiting 
inner ear valve is to maintain the physiologically normal endolymphatic 
pressure and to ensure a unidirectional flow of endolymph.
    Hood Laboratories' endolymphatic shunt tube with valve is the only 
device of its type in commercial distribution in the United States. It 
consists of a silicone catheter connected to a silicone tube that is 
inside a molded silicone body. The inside silicone tube has a slit 
valve at one end that allows the endolymph to exit. The silicone tube 
is inserted into the end of the endolymphatic sac to allow the 
endolymph to flow through the valve and into the mastoid cavity via the 
tail-like portion of the molded silicone body.

IV. Proposed Reclassification

    FDA is proposing to reclassify the endolymphatic shunt tube with 
valve intended to be implanted in the inner ear to relieve the symptoms 
of vertigo and hearing loss due to endolymphatic hydrops of Meniere's 
disease from class III to class II. FDA believes that class II with the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Endolymphatic Shunt Tube With Valve'' as the special control 
would provide reasonable assurance of safety and effectiveness of the 
device.

V. Risks to Health

    When the device was classified into class III (51 FR 40378), FDA 
identified the primary risk to health presented by the device as a 
build up of fluid pressure in the inner ear due to a clogged or 
inoperative valve. FDA also believed that any surgical procedure to 
correct a defective valve presented additional risks to health, 
including infection due to revision surgery.
    During the open public meeting (June 11, 1992) (Ref. 2) and review 
of the first Hood Laboratories reclassification petition, the Panel 
noted the similarities between the valved and nonvalved

[[Page 42811]]

shunts. Both the valved shunt device (class III) and the nonvalved 
shunt device (class II) drain excess endolymph from the distended end 
of the endolymphatic system into the mastoid cavity where resorption 
occurs. They further noted that both devices are intended to relieve 
the symptoms of Meniere's disease. The nonvalved shunt (class II 
device) permits the unrestricted flow of excess endolymph, while the 
valved shunt (class III device) is intended to control the flow of 
endolymph so that a normal endolymphatic pressure is maintained. During 
its review and discussion of the first petition (June 11, 1992), the 
Panel also acknowledged the difficulty in diagnosing, treating, and 
assessing the treatment plans for Meniere's disease and could not agree 
that the valved shunt is effective, but believed the device ``does 
something worthwhile'' in treating the symptoms. An invited guest 
speaker (Ref. 13) was concerned with the long-term functioning and 
integrity of the capillary tubing material, SupramidTM, that 
was used in Hood Laboratories' shunt.
    FDA noted that the benefits resulting from implantation of the 
endolymphatic shunt tube with valve, i.e., relief of vertigo, 
fluctuating hearing loss, tinnitus, and aural fullness which typifies 
Meniere's disease, appeared to be very similar to those resulting from 
implantation of the nonvalved shunt (Ref. 2). At the end of the 
meeting, FDA believed that there were potential benefits of the device 
in improving hearing, relief of vertigo, reduction of fullness in the 
ear, and mitigation of tinnitus. However, FDA believed that the 
petitioner had not adequately addressed the concerns about any buildup 
of fluid pressure in the inner ear due to a clogged or inoperative 
valved device, or the risk of infection from revision surgery. FDA 
believed that sufficient information existed regarding the risks 
associated with the device, but that the information needed to be 
assembled in such a way as to enable the agency to determine the safety 
and effectiveness of the device for its intended use.
    Since that time, the petitioner has assembled additional 
information regarding the risks associated with the endolymphatic shunt 
tube with valve. Huang and Lin (Ref. 3) and Arenberg (Ref. 4) report 
that risks such as incidence of infections and clogging have similar 
occurrences in the valved and nonvalved endolymphatic shunts. Both 
shunts have been used for more than 20 years without reportable events 
of major or frequent safety or effectiveness problems. A search of 
FDA's medical device reporting (MDR) database reveals no deaths, 
serious injuries, or malfunctions. Although the claim of maintaining 
normal endolymphatic pressure by the valved shunt has not been 
established during its use over the past 20 years, FDA now believes 
that the risks previously identified with the valved shunt are not 
substantially different from those associated with the nonvalved shunt, 
and that special controls would provide reasonable assurance of the 
safety and effectiveness of the device.

VI. Summary of Reasons for Reclassification

    After considering the new information contained in the petitioner's 
second petition, reevaluation of the data contained in the first 
petition, and more than 20 years of safe use of the device, FDA 
believes that special controls would provide reasonable assurance of 
the safety and effectiveness of the endolymphatic shunt tube with valve 
for its intended use. Observational data (Refs. 4 through 12) suggest 
that the shunt tube with valve may preserve hearing and reduce or 
eliminate symptoms in some persons with Meniere's disease who require 
surgical intervention. FDA believes that the endolymphatic shunt tube 
with valve intended to be implanted in the inner ear to relieve the 
symptoms of vertigo and hearing loss due to endolymphatic hydrops of 
Meniere's disease should be reclassified into class II because special 
controls, in addition to general controls, would provide reasonable 
assurance of the safety and effectiveness of the device, and there is 
now sufficient information to establish special controls to provide 
such assurance.

VII. Summary of Data Upon Which the Reclassification is Based

    In addition to the potential risks identified above, there are 
potential benefits of the device in improving hearing: (1) Relief of 
vertigo, (2) reduction of the fullness in the ear, and (3) mitigation 
of tinnitus. Observational data, including case reports submitted by 
Hood Laboratories, suggest that the valved shunt may preserve hearing 
and reduce or eliminate symptoms in persons with Meniere's disease who 
require surgical intervention (Refs. 4 through 12).
    Wright (Ref. 9) maintains that the valved implant is superior to 
other methods of endolymphatic sac surgery after 7 years of experience 
and followup. Stahle (Ref. 7) reports that his results suggest that the 
pressure-sensitive, unidirectional inner ear valve is safe for long-
term human implantation. He also reports that severely incapacitated 
patients can be relieved of vertigo without a destructive 
labyrinthectomy and can have significant sustained sensory hearing 
improvements as well. Other data suggest improved hearing in patients 
with the valved shunt as compared to patients implanted with the 
nonvalved shunt (Refs. 8 through 9). The determination of the lack of 
injury to the inner ear is based upon indirect evidence such as 
audiological testing and the evaluation of vertigo.
    Based on the available information, FDA believes that the special 
control discussed below is capable of providing reasonable assurance of 
the safety and effectiveness of the endolymphatic shunt tube with valve 
with regard to the identified risks to health of this device.

VIII. Special Control

    In addition to general controls, FDA believes that the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Endolymphatic Shunt Tube With Valve,'' is an adequate special control 
to address the potential risks to health described for this device. 
Technical areas noted in the guidance to address the potential risks to 
health for this device include:

A. Labeling

    Based on the scientific data available, FDA believes labeling that 
restricts the use of the device to patients considered appropriate by 
the attending physician will lessen the need for revision surgery.

B. Valve Performance

    One hundred percent sample testing, prior to implantation, would 
demonstrate valve performance equivalency to any currently marketed 
device.

C. Materials Specification

    Adherence to a bio-material with chemical stability in a 
physiological environment will address the concern of long-term 
functioning and integrity of the device.

D. Biocompatibility Testing

    Adherence to biocompatibility testing procedures presented in FDA, 
Center for Devices and Radiological Health, Office of Device 
Evaluation, Blue Book Memorandum G95-1, ``Use of International Standard 
ISO-10993-1, Biological Evaluation of Medical Devices Part-1: 
Evaluation and Testing,'' (Ref. 14) can control the risk of adverse 
tissue reaction.

[[Page 42812]]

E. Sterility Testing

    Adherence to the sterility testing procedures presented in the 
guidance document entitled ``510(k) Sterility Review Guidance,'' 
January 2, 1990 (K90-1) (Ref. 15) can help control the risk of 
infection by guarding against the implantation of an unsterile device.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed 
reclassification 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 Enforcement 
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 
proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the proposed 
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. Because reclassification will reduce regulatory costs with 
respect to this device, it will impose no significant economic impact 
on any small entities, and it may permit small potential competitors to 
enter the marketplace by lowering their costs. The agency therefore 
certifies that this reclassification action, if finalized, will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this reclassification action will not impose 
costs of $100 million or more on either the private sector or State, 
local, and tribal governments in the aggregate, and therefore a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

XI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
information that is subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995. The special control 
does not require the respondent to submit additional information.

XII. Submission of Comments and Proposed Dates

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this proposal 
by November 13, 2001. Two copies of any comments are to be submitted 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments are available for review in the office 
above between 9 a.m. and 4 p.m., Monday through Friday. FDA proposes 
that any final regulation based on this proposal become effective 30 
days after its date of publication in the Federal Register.

XIII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. E. Benson Hood Laboratories, Inc., Reclassification Petition, 
May 27, 1997.
    2. Transcript of 36th Meeting of the Ear, Nose, and Throat 
Devices Panel, Washington DC, June 11, 1992.
    3. Huang, T. S. and C. C. Lin, ``Endolymphatic Sac Surgery for 
Meniere's Disease: A Composite Study of 339 Cases,'' Laryngoscope, 
vol. 95, pp. 1082-1086, 1985.
    4. Letter from I. Kaufman Arenberg, Ear Center, P.C. to Lew 
Martin, Hood Laboratories, April 1, 1991.
    5. Letter from J. William Wright III, Ear Institute of Indiana 
to Lew Martin, Hood Laboratories, January 15, 1991.
    6. Letter from Tsun-Sheng Huang, Chang Gung Memorial Hospital to 
Lew Martin, March 14, 1991.
    7. Stahle, J. and I. K. Arenberg, ``Ten Year Follow-up on the 
First Five Inner Ear Valve Implants for Intractable Vertigo in 
Sweden,'' American Journal of Otology, vol. 8, pp. 287-293, 1987.
    8. Huang, T. S., ``Valve Implants Compared to Other Surgical 
Methods,'' American Journal of Otology, vol. 8, pp. 301-306, 1987.
    9. Wright, J. W. and G. W. Hicks, ``Valved Implants in 
Endolymphatic Sac Surgery,'' American Journal of Otology, vol. 8, 
pp. 307-312, 1987.
    10. Arenberg, I. K. and T. J. Balkany, ``Revision Endolymphatic 
Sac and Duct Surgery for Recurrent Meniere's Disease and Hydrops: 
Failure Analysis and Technical Aspects,'' Laryngoscope, p. 92, 
November 1982.
    11. Arenberg, I. K., ``The Fine Points of Valve Implant Surgery 
for Hydrops: An Update,'' American Journal of Otology, vol. 3, No. 
4, April 1982.
    12. Arenberg, I. K. and W. P. R. Gibson, ``Nondestructive 
Surgery for Vertigo,'' Operative Challenges in Otolaryngology Head 
and Neck Surgery, edited by H. C. Pillsbury and M. M. Goldsmith, 
Mosby Yearbook Publishing, 1990.
    13. Presentation by Mattox, D. E., Johns Hopkins University, 
``Histology and Ultrastructure of Explanted Shunts with Valves,'' at 
the 36th Meeting of the Ear, Nose, and Throat Devices Panel, 
Washington DC, June 11, 1992.
    14. FDA, Center for Devices and Radiological Health, Office of 
Device Evaluation, Blue Book Memorandum G95-1, ``Use of 
International Standard ISO-10993-1, Biological Evaluation of Medical 
Devices Part-1: Evaluation and Testing.''
    15. FDA, Center for Devices and Radiological Health, Office of 
Device Evaluation, Guidance Document ``510(k) Sterility Review 
Guidance,'' February 12, 1990 (K90-1).

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend part 874 as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

    1. The authority citation for 21 CFR part 874 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 874.3850 is revised to read as follows:


Sec. 874.3850  Endolymphatic shunt tube with valve.

    (a) Identification. An endolymphatic shunt tube with valve is a 
device that consists of a pressure-limiting valve associated with a 
tube intended to be implanted in the inner ear to relieve symptoms of 
vertigo and hearing loss due to endolymphatic hydrops (increase in 
endolymphatic fluid) of Meniere's disease.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Endolymphatic Shunt Tube With 
Valve.''


[[Page 42813]]


    Dated: August 2, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-20571 Filed 8-14-01; 8:45 am]
BILLING CODE 4160-01-S