[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Rules and Regulations]
[Pages 17138-17148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7779]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 870, 872, 874, 876, 878, 884, 886, and 888

[Docket No. 99N-0035]


Medical Devices; Reclassification of 28 Preamendments Class III 
Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is reclassifying 28 
preamendments devices from class III (premarket approval) into class II 
(special controls). FDA is also identifying the special controls that 
the agency believes will reasonably ensure the safety and effectiveness 
of the devices. This reclassification is being undertaken on the 
agency's own initiative based on new information under the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical 
Devices Act of 1990 and the FDA Modernization Act of 1997. The agency 
is also revising the identification of six of the devices subject to 
this rule to more accurately reflect the characteristics of devices 
actually being marketed. FDA is withholding action on 11 devices, which 
the agency proposed to reclassify, pending further action.

DATES: This rule is effective May 1, 2000.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 15, 1999 (64 FR 12774), FDA 
published a proposed rule to reclassify 38 preamendments class III 
devices into class II and to establish special controls for these 
devices. FDA invited interested persons to comment on the proposed rule 
by June 14, 1999.
    FDA received one request to reopen the comment period for six 
devices. The request noted that FDA had not made the guidance documents 
that were proposed as special controls for these six devices available 
for comment through FDA's Good Guidance Practices (GGP's). The request 
further said that it was impossible to comment on the

[[Page 17139]]

proposed reclassification without the guidance documents being 
available. Therefore, the requestor asked that FDA extend the comment 
period until at least 90 days after the guidance documents are publicly 
available.
    FDA agrees with the request. FDA has also identified an additional 
three devices for which FDA had not issued the guidance documents 
proposed as special controls in accordance with the GGP policy. 
Therefore, FDA is withholding action on the devices listed in table 1 
of this document at this time. FDA will make the guidance documents for 
these devices available for comment through the GGP process and will 
reopen the comment period on the reclassification of these devices when 
the guidance documents are available.
    FDA also received a request for an extension of the comment period 
for the cutaneous oxygen monitor (Sec. 868.2500 (21 CFR 868.2500)) on 
behalf of a foreign manufacturer. The manufacturer needed additional 
time to translate the proposed special controls documents to prepare 
their comments. FDA granted this request and will withhold action on 
this device and reopen the comment period.

         Table 1.--Devices Not Subject of This Reclassification
------------------------------------------------------------------------
           21 CFR Section                         Device Name
------------------------------------------------------------------------
868.1150                             Indwelling blood carbon dioxide
                                      partial pressure (Pco\2\) analyzer
868.1170                             Indwelling blood hydrogen ion
                                      concentration (pH) analyzer
868.1200                             Indwelling blood oxygen partial
                                      pressure (Po\2\) analyzer
868.2500                             Cutaneous oxygen monitor
870.3450                             Vascular graft prosthesis of less
                                      than 6 millimeters diameter
870.3620                             Pacemaker lead adaptor
870.3800                             Annuloplasty ring
870.4230                             Cardiopulmonary bypass defoamer
870.4260                             Cardiopulmonary bypass arterial
                                      blood line filter
870.4350                             Cardiopulmonary bypass oxygenator
------------------------------------------------------------------------

II. Comments

    FDA received five comments on the proposal. The following is a 
summary of the comments and FDA's response:
    (Comment 1) One comment supported the proposal to reclassify four 
orthopedic devices: The elbow joint metal/polymer constrained cemented 
prosthesis (Sec. 888.3150 (21 CFR 888.3150)), the knee joint 
patellofemoral polymer/metal semi-constrained cemented prosthesis 
(Sec. 888.3540 (21 CFR 888.3540)), the shoulder joint metal/polymer 
non-constrained cemented prosthesis (Sec. 888.3650 (21 CFR 888.3650)), 
and the shoulder joint metal/polymer semi-constrained cemented 
prosthesis (Sec. 888.3660 (21 CFR 888.3660)).
    FDA agrees with this comment.
    (Comment 2) One comment supported the proposed reclassification and 
special controls for the tinnitus masker (Sec. 874.3400 (21 CFR 
874.3400)).
    FDA agrees with this comment.
    (Comment 3) A third comment addressed the vascular graft prosthesis 
of less than 6 millimeters diameter (Sec. 870.3450).
    As noted above, FDA is withholding action on this device, until the 
proposed guidance document intended to be a special control is made 
available for comment. FDA will address this comment when it takes 
final action on this device.
    (Comment 4) One manufacturer agreed with the proposal to reclassify 
the over-the-counter (OTC) denture cushion or pad (Sec. 872.3540 (21 
CFR 872.3540)) but recommended that it be reclassified from class III 
into class I. The manufacturer submitted data on the device to support 
the claim that general controls are adequate to provide reasonable 
assurance of the safety and effectiveness of the device. The comment 
agreed that proper labeling is important to control risks to health 
associated with the use of this device.
    FDA disagrees with this comment. FDA believes it is necessary that 
consumers have appropriate directions for use to correctly prepare 
denture material for a properly fitted denture. The guidance document 
describes the information necessary to provide reasonable assurance of 
the safe and effective use of the OTC dental pad or cushion. In 
particular, it includes descriptive information on the indications for 
use, contraindications, cautions, and potential adverse effects for the 
device, as well as the directions for use information regarding 
adequate mixing, preparation, and use of the product. The guidance 
document also provides ways that a manufacturer can establish that 
there is reasonable assurance that an OTC denture cushion or pad with a 
new intended use, chemical composition, labeling claims, or method of 
preparation is safe and effective.
    (Comment 5) One comment raised three issues concerning the proposed 
reclassification of the high permeability hemodialysis system 
(Sec. 876.5860 (21 CFR 876.5860)) as follows:
    1. The comment recommended changing the name and the section 
heading of Sec. 876.5860 to include three additional therapies: 
Hemofiltration, hemoconcentration, and hemodiafiltration.
    FDA notes that it has cleared these three additional renal 
therapies identified by the comment under Sec. 876.5860. FDA will not 
revise the name of the device but it will revise the first sentence of 
the identification section (Sec. 876.5860(a)) as follows: ``A high 
permeability hemodialysis system is a device intended for use as an 
artificial kidney system for treatment of patients with renal failure, 
fluid overload, or toxemic conditions by performing such therapies as 
hemodialysis, hemofiltration, hemoconcentration, and 
hemodiafiltration.''
    2. The comment also recommended further revising the identification 
of the high permeability hemodialysis system to state that the 
hemofiltration, hemoconcentration, and hemodiafiltration 
ultrafiltration coeficient (Kuf ) should be changed from 
``greater than 12 ml/hr/mmHg'' to ``greater than 8 ml/hr/mmHg''.
    FDA agrees with the comment with the provision that the bovine or 
expired human blood be used to measure the Kuf. In the final 
rule, Sec. 876.5860(a)(1) is revised to read:
    The hemodialyzer consists of a semipermeable membrane with an in 
vitro ultrafiltration coefficient (Kuf) greater than 8 
milliliters per hour per conventional millimeter of mercury, as 
measured with bovine or expired human blood, and is used with either an 
automated ultrafiltration controller or another method of 
ultrafiltration control to prevent fluid imbalance.
    3. The comment also recommended that any revisions to the 
hemodialysis-related guidance documents be implemented as Level 1 
guidance documents under FDA's GGP's.
    FDA will follow its GGP's in issuing revisions to guidance 
documents used as special controls for this device as well as for all 
devices.
    (Comment 6) FDA also made the following changes on its own 
initiative for accuracy and clarity:
    1. FDA incorrectly cited the title of its biocompatibility guidance 
and is correcting the title of the guidance to read, ``Use of 
International Standard ISO 10993 `Biological Evaluation of Medical 
Devices Part I: Evaluation and Testing'.''

[[Page 17140]]

The special control is the FDA guidance document and not the ISO 
consensus standard itself.
    2. In Sec. 874.3930--Tympanostomy tube with semipermeable membrane 
(21 CFR 874.3930), FDA deleted the proposed special controls except the 
device specific guidance document. FDA believes that the guidance 
document adequately addresses the other proposed special controls.
    3. In Sec. 876.4480--Electrohydraulic lithotriptor (21 CFR 
876.4480), FDA deleted the proposed special controls except the device 
specific FDA guidance document. FDA believes that the guidance document 
adequately addresses the other proposed special controls.
    4. In Sec. 876.5860--High permeability hemodialysis system, FDA 
deleted the American National Standards Institute (ANSI)/Association 
for the Advancement in Medical Instrumentation (AAMI) and United States 
Pharmacopeia (USP) standards because FDA believes that these standards 
are adequately addressed in the FDA sterility guidance.
    5. In Sec. 884.1060--Endometrial aspirator (21 CFR 884.1060); 21 
CFR 884.1110--Endometrial brush; and Sec. 884.1185--Endometrial washer 
(21 CFR 884.1185), FDA clarified the wording of the labeling and design 
and testing special controls.
    6. In Sec. 884.4100--Endoscopic electrocautery and accessories (21 
CFR 884.4100), and Sec. 884.4150--Bipolar endoscopic coagulator-cutter 
and accessories (21 CFR 884.4150), FDA added the complete titles and 
years of the standards and clarified the labeling and treatment 
instructions. In the preamble to the proposed rule, FDA identified the 
sterility guidance as a special control for these two devices but did 
not include it in the regulatory text. FDA has included the sterility 
guidance in the regulatory text of the final rule.
    7. In some device identifications, FDA made minor editorial 
changes.

III. FDA's Conclusion

    FDA has concluded, based on a review of the available information, 
that the special controls identified in tables 2 and 3 of this document 
provide reasonable assurance of the safety and effectiveness of these 
28 devices. The two tables summarize the special controls to be applied 
to each device.

                       Table 2.--Summary of FDA Guidance Special Controls Listed by Device
----------------------------------------------------------------------------------------------------------------
                                           FDA Sterility Review    FDA Biocompatibility
21 CFR Section        Device Name               Guidance1                Guidance2          Other FDA Guidance
----------------------------------------------------------------------------------------------------------------
    864.7250    Erythropoietin Assay                                                      3
    864.7300    Fibrin monomer                                                            4
                 paracoagulation test
    870.3375    Cardiovascular           X                        X                       5
                 intravascular filter
    872.3540    OTC denture cushion or                            X                       6
                 pad
    872.3560    OTC denture reliner                               X                       6
    872.3570    OTC denture repair kit                            X                       6
    872.3600    Partially fabricated                              X                       6
                 denture kit
    874.3930    Tympanostomy tube with                                                    7
                 semipermeable membrane
    876.4480    Electrohydraulic                                                          8
                 lithotriptor
    876.5860    High permeability                                 X                       9,10,11,12
                 hemodialysis system
    876.5955    Peritoneo-venous shunt   X                        X
    878.3610    Esophageal prosthesis                                                     13
    878.3720    Tracheal prosthesis                                                       13
    884.1060    Endometrial aspirator    X                        X
    884.1100    Endometrial brush        X                        X
    884.1185    Endometrial washer       X                        X
    884.4100    Endoscopic               X                        X                       14
                 electrocautery and
                 accessories
    884.4150    Bipolar endoscopic       X                        X                       14
                 coagulator-cutter
    886.3400    Keratoprosthesis         X                        X                       15
    886.3920    Eye valve implant        X                        X                       16
    888.3150    Elbow joint metal/       X                        X                       17,18,19
                 polymer constrained
                 cemented prosthesis
    888.3540    Knee joint               X                        X                       17,18,19
                 patellofemoral polymer/
                 metal semi-constrained
                 cemented prosthesis
    888.3650    Shoulder joint metal/    X                        X                       17,18,19
                 polymer non-
                 constrained cemented
                 prosthesis
    888.3660    Shoulder joint metal/    X                        X                       17,18,19
                 polymer semi-
                 constrained cemented
                 prosthesis
----------------------------------------------------------------------------------------------------------------
(1) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1)''
(2) ``Use of International Standard ISO 10993 `Biological Evaluation of Medical Devices Part I: Evaluation and
  Testing,' ''
(3) `` Document for Special Controls for Erythropoietin Assay Premarket Notification [510(k)s],''
(4) ``In Vitro Diagnostic Fibrin Monomer Paracoagulation Test, ''
(5) ``Guidance for Cardiovascular Intravascular Filters 510(k) Submissions,''
(6) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits,''
(7) ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification,''
(8) ``Guidance for the Content of Premarket Notifications for Intracorporal Lithotripters,''

[[Page 17141]]

 
(9) ``Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,''
(10) ``Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis
  Delivery Systems,''
(11) ``Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for
  Hemodialysis,''
(12) ``Guidance for Hemodialyzer Reuse Labeling,''
(13) ``Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses,
(14) ``Guidance (`Guidelines') for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and
  Accessories),''
(15) ``Guidance on 510(k) Submissions for Keratoprosthesis,''
(16) ``Aqueous Shunt-510(k) Submissions,''
(17 ``Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone
  Cement,''
(18) ``Guidance Document for Testing Non-articulating, `Mechanically Locked' Modular Implant Components,'' and
(19) ``Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic
  Devices.''


                                Table 3.--Other Special Controls Listed by Device
----------------------------------------------------------------------------------------------------------------
                                                                                                 Design and
    21 CFR Section          Device Name              Labeling              Standards         Performance Testing
----------------------------------------------------------------------------------------------------------------
866.3510               Rubella virus                                 NCCLS \1\              ....................
                        serological reagents                           1/LA6, October
                                                                      1997,
                                                                       1/LA18, December
                                                                      1994,
                                                                       D13, October 1993,
                                                                       EP5, February 1999,
                                                                       EP10, May 1998.
                                                                       CDC \2\
                                                                       Low Titer Rubella
                                                                      Standard,
                                                                       Reference Panel of
                                                                      Well Characterized
                                                                      Rubella Sera.
                                                                       WHO \3\
                                                                       Rubella Standard.
870.5550               External                                      ANSI/AAMI \4\          The maximum pulse
                        transcutaneous                                 DF-2                  amplitude should
                        cardiac pacemaker                                                    not exceed 200 mA.
                        (noninvasive)                                                        The maximum pulse
                                                                                             duration should not
                                                                                             exceed 50 msec.
872.6080               Airbrush                                      IEC \5\
                                                                       60601-1-AM2 (1995-
                                                                      03),
                                                                       Amendment 2
874.3400               Tinnitus masker        Patient labeling re:
                                               hearing health care
                                               professional
                                               diagnosis, fitting
                                               and followup care;
                                               risks; benefits;
                                               warnings; and
                                               specifications.
876.5955               Peritoneo-venous                                                     Backflow
                        shunt                                                                specifications to
                                                                                             prevent reflux of
                                                                                             blood into the
                                                                                             shunt.
884.1060               Endometrial aspirator  Indication: Only to                           Sampling component
                                               evaluate the                                  is covered within
                                               endometrium.                                  the vagina.
                                              Contraindications:
                                               pregnancy, history
                                               of recent uterine
                                               perforation, and
                                               recent cesarean
                                               section.
884.1100               Endometrial brush      Indication: Only to                           Sampling component
                                               evaluate the                                  is covered within
                                               endometrium.                                  the vagina.
                                              Contraindications:                            Adherence of
                                               Pregnancy, history                            bristles and brush
                                               of recent uterine                             head.
                                               perforation, and
                                               recent cesarean
                                               section.
884.1185               Endometrial washer     Indication: Only to                           Maximum intrauterine
                                               evaluate the                                  pressure should not
                                               endometrium.                                  exceed 50
                                              Contraindications:                             millimeters of
                                               Pregnancy, history                            mercury.
                                               of recent uterine                            Sampling component
                                               perforation, and                              is covered within
                                               recent cesarean                               the vagina
                                               section.
                                              Warning: Do not
                                               attach to wall or
                                               any external
                                               suction.

[[Page 17142]]

 
884.4100               Endoscopic             Indication: For        ANSI/AAMI
                        electrocautery and     female tubal            HF-18
                        accessories            sterilization.        IEC
                                              Instructions for use:    60601-1-1-AM2
                                              Destroy at least 2 cm    (1995-03) Amendment
                                               of the fallopian       2
                                               tube;
                                              Use a cut (or
                                               undampened
                                               sinusoidal) wave
                                               form; and
                                              Use a minimum power
                                               of 25 watts.
                                              For devices with
                                               ammeters: continue
                                               electrode activation
                                               for 5 seconds after
                                               the visual endpoint
                                               (tissue blanching)
                                               is reached or
                                               current flow ceases
                                               indicating adequate
                                               tissue destruction.
884.4150               Bipolar endoscopic     Indication: For        ANSI/AAMI
                        coagulator-cutter      female tubal            HF-18
                                               sterilization.        IEC
                                              Instructions for use:    60601-1-1-AM2
                                              Destroy at least 2 cm    (1995-03) Amendment
                                               of the fallopian       2
                                               tube;
                                              Use a cut (or
                                               undampened
                                               sinusoidal) wave
                                               form; and
                                              Use a minimum power
                                               of 25 watts.
                                              For devices with
                                               ammeters: continue
                                               electrode activation
                                               for 5 seconds after
                                               the visual endpoint
                                               (tissue blanching)
                                               is reached or
                                               current flow ceases
                                               indicating adequate
                                               tissue destruction.
888.3150               Elbow joint metal/                            ASTM \6\
                        polymer constrained                            F 75-92,
                        cemented prosthesis                            F 648-98,
                                                                       F 799-96,
                                                                       F 981-93,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95,
                                                                       F 1537-94.
                                                                     ISO \7\
                                                                       5832-3,4, &
                                                                      12:1996,
                                                                       5833:1992,
                                                                       5834-2;1998,
                                                                       6018:1997,
                                                                       9001:1994,
                                                                       14630:1997.
888.3540                 Knee joint                                  ASTM
                        patellofemoral                                 F 75-92,
                        polymer/metal semi-                            F 648-98
                        constrained cemented                           F 799-96,
                        prosthesis                                     F 1044-95
                                                                       F 1108-97,
                                                                       F 1147-95,
                                                                       F 1537-94,
                                                                       F 1672-95.
                                                                     ISO
                                                                       5832-3,4, &
                                                                      12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       7207-2:1998,
                                                                       9001:1994.

[[Page 17143]]

 
888.3650               Shoulder joint metal/                         ASTM
                        polymer non-                                   F 75-92,
                        constrained cemented                           F 648-98,
                        prosthesis                                     F 799-96,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95;
                                                                       F-1378-97,
                                                                       F 1537-94.
                                                                     ISO
                                                                       5832-3,4 & 12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       9001:1994.
888.3660               Shoulder joint metal/                         ASTM
                        polymer semi-                                  F 75-92,
                        constrained cemented                           F 648-98,
                        prosthesis                                     F 799-96,
                                                                       F 1044-95,
                                                                       F 1108-97,
                                                                       F 1147-95;
                                                                       F 1378-97,
                                                                       F 1537-94.
                                                                     ISO
                                                                       5832-3,4 & 12:1996,
                                                                       5833:1992,
                                                                       5834-2:1998,
                                                                       6018:1987,
                                                                       9001:1994.
----------------------------------------------------------------------------------------------------------------
\1\ National Committee for Clinical Laboratory Standards, 940 West Valley Rd., suite 1400, Wayne, PA 19087, 610-
  688-0100, http://www.nccls.org.
\2\ Centers for Disease Control and Prevention, Mail Stop G18, 1600 Clifton Rd. NE., Atlanta, GA 30333.
\3\ World Health Organization International Laboratory for Biological Standards, Statens Seruminstitut, Center
  for Prevention and Control of Infectious Diseases and Congenital Disorders, 5 Artillerivej, DK-2300 Copenhagen
  S, Denmark.
\4\ American National Standards Institute and Association for the Advancement of Medical Instrumentation, 11
  West 42d St., New York, NY 10036.
\5\ International Electrotechnical Commission, AT3, Rue de Varembe, P.O. Box 131, Geneva, Switzerland CH-1211,
  http://www.iec.ch.
\6\ American Society for Testing and Materials, Customer Services, 100 Barr Harbor Dr., West Conshohocken, PA
  19428.
\7\ International Organization for Standardization, Case Postale, Geneva, Switzerland CH-1121.

IV. Environmental Impact

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

V. Analysis of Impacts

    FDA has examined the impacts of the 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 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 these devices from class III 
will relieve all manufacturers of these devices of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Moreover, compliance with special controls proposed for these 
devices will not impose significant new costs on affected manufacturers 
as most of these devices already comply with the proposed special 
controls. Because reclassification will reduce regulatory costs with 
respect to these devices, 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 rule will not have a significant economic impact on 
a substantial number of small entities. In addition, this proposed rule 
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.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this proposed rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

[[Page 17144]]

List of Subjects

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Parts 870, 872, 874, 876, 878, 884, and 888

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
864, 866, 870, 872, 874, 876, 878, 884, 886, and 888 are amended as 
follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    1. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 864.7250 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 864.7250  Erythropoietin assay.

* * * * *
    (b) Classification. Class II. The special control for this device 
is FDA's ``Document for Special Controls for Erythropoietin Assay 
Premarket Notification (510(k)s).''
    3. Section 864.7300 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 864.7300  Fibrin monomer paracoagulation test.

* * * * *
    (b) Classification. Class II. The special control for this device 
is FDA's ``In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.''

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    4. The authority citation for 21 CFR part 866 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    5. Section 866.3510 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 866.3510  Rubella virus serological reagents.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) National Committee for Clinical Laboratory Standards':
    (i) 1/LA6 ``Detection and Quantitation of Rubella IgG Antibody: 
Evaluation and Performance Criteria for Multiple Component Test 
Products, Speciment Handling, and Use of the Test Products in the 
Clinical Laboratory, October 1997,''
    (ii) 1/LA18 ``Specifications for Immunological Testing for 
Infectious Diseases, December 1994,''
    (iii) D13 ``Agglutination Characteristics, Methodology, 
Limitations, and Clinical Validation, October 1993,''
    (iv) EP5 ``Evaluation of Precision Performance of Clinical 
Chemistry Devices, February 1999,'' and
    (v) EP10 ``Preliminary Evaluation of the Linearity of Quantitive 
Clinical Laboratory Methods, May 1998,''
    (2) Centers for Disease Control's:
    (i) Low Titer Rubella Standard,
    (ii) Reference Panel of Well Characterized Rubella Sera, and
    (3) World Health Organization's International Rubella Standard.

PART 870--CARDIOVASCULAR DEVICES

    6. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    7. Section 870.3375 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 870.3375  Cardiovascular intravascular filter.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) ``Use of International Standards Organization's ISO 10993 
`Biological Evaluation of Medical Devices Part I: Evaluation and 
Testing,' '' and
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 2/12/90 
(K90-1)'' and
    (ii) ``Guidance for Cardiovascular Intravascular Filter 510(k) 
Submissions.''
    8. Section 870.5550 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 870.5550  External transcutaneous cardiac pacemaker (noninvasive).

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) ``American National Standards Institute/American Association 
for Medical Instrumentation's DF-21 `Cardiac Defibrillator Devices' '' 
2d ed., 1996, and
    (2) ``The maximum pulse amplitude should not exceed 200 
milliamperes. The maximum pulse duration should not exceed 50 
milliseconds.''

PART 872--DENTAL DEVICES

    9. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    10. Section 872.3540 is amended by revising paragraph (b)(2) and by 
removing paragraph (c) to read as follows:


Sec. 872.3540  OTC denture cushion or pad.

* * * * *
    (b) * * *
    (2) Class II if the OTC denture cushion or pad is made of a 
material other than wax-impregnated cotton cloth or if the intended use 
of the device differs from that described in paragraph (b)(1) of this 
section. The special controls for this device are FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical--Devices Part I: Evaluation and Testing,' '' and
    (ii) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''
    11. Section 872.3560 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 872.3560  OTC denture reliner.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''
    12. Section 872.3570 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 872.3570  OTC denture repair kit.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''
    13. Section 872.3600 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 872.3600  Partially fabricated denture kit.

* * * * *

[[Page 17145]]

    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''
    14. Section 872.6080 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 872.6080  Airbrush.

* * * * *
    (b) Classification. Class II. The special control for this device 
is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-
03), Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety.''

PART 874--EAR, NOSE, AND THROAT DEVICES

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

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    16. Section 874.3400 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 874.3400  Tinnitus masker.

* * * * *
    (b) Classification. Class II. The special control for this device 
is patient labeling regarding:
    (1) Hearing health care professional diagnosis, fitting of the 
device, and followup care,
    (2) Risks,
    (3) Benefits,
    (4) Warnings for safe use, and
    (5) Specifications.
    17. Section 874.3930 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 874.3930  Tympanostomy tube with semipermeable membrane.

* * * * *
    (b) Classification. Class II. The special control for this device 
is FDA's ``Tympanostomy Tubes, Submission Guidance for a 510(k).''

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    18. 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.

    19. Section 876.4480 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 876.4480  Electrohydraulic lithotriptor.

* * * * *
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance for the Content of Premarket Notifications for 
Intracorporeal Lithotripters.''
    20. Section 876.5860 is revised to read as follows:


Sec. 876.5860  High permeability hemodialysis system.

    (a) Identification. A high permeability hemodialysis system is a 
device intended for use as an artificial kidney system for the 
treatment of patients with renal failure, fluid overload, or toxemic 
conditions by performing such therapies as hemodialysis, 
hemofiltration, hemoconcentration, and hemodiafiltration. Using a 
hemodialyzer with a semipermeable membrane that is more permeable to 
water than the semipermeable membrane of the conventional hemodialysis 
system (Sec. 876.5820), the high permeability hemodialysis system 
removes toxins or excess fluid from the patient's blood using the 
principles of convection (via a high ultrafiltration rate) and/or 
diffusion (via a concentration gradient in dialysate). During 
treatment, blood is circulated from the patient through the 
hemodialyzer's blood compartment, while the dialysate solution flows 
countercurrent through the dialysate compartment. In this process, 
toxins and/or fluid are transferred across the membrane from the blood 
to the dialysate compartment. The hemodialysis delivery machine 
controls and monitors the parameters related to this processing, 
including the rate at which blood and dialysate are pumped through the 
system, and the rate at which fluid is removed from the patient. The 
high permeability hemodialysis system consists of the following 
devices:
    (1) The hemodialyzer consists of a semipermeable membrane with an 
in vitro ultrafiltration coefficient (Kuf) greater than 8 
milliliters per hour per conventional millimeter of mercury, as 
measured with bovine or expired human blood, and is used with either an 
automated ultrafiltration controller or anther method of 
ultrafiltration control to prevent fluid imbalance.
    (2) The hemodialysis delivery machine is similar to the 
extracorporeal blood system and dialysate delivery system of the 
hemodialysis system and accessories (Sec. 876.5820), with the addition 
of an ultrafiltration controller and mechanisms that monitor and/or 
control such parameters as fluid balance, dialysate composition, and 
patient treatment parameters (e.g., blood pressure, hematocrit, urea, 
etc.).
    (3) The high permeability hemodialysis system accessories include, 
but are not limited to, tubing lines and various treatment related 
monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood 
recirculation monitors).
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Device--Part I: Evaluation and Testing,' ''
    (2) ``Guidance for the Content of 510(k)s for Conventional and High 
Permeability Hemodialyzers,''
    (3) ``Guidance for Industry and CDRH Reviewers on the Content of 
Premarket Notifications for Hemodialysis Delivery Systems,''
    (4) ``Guidance for the Content of Premarket Notifications for Water 
Purification Components and Systems for Hemodialysis,'' and
    (5) ``Guidance for Hemodialyzer Reuse Labeling.''
    21. Section 876.5955 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 876.5955  Peritoneo-venous shunt.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) Backflow specification and testing to prevent reflux of blood 
into the shunt.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    22. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    23. Section 878.3610 is revised to read as follows:


Sec. 878.3610  Esophageal prosthesis.

    (a) Identification. An esophageal prosthesis is a rigid, flexible, 
or expandable tubular device made of a plastic, metal, or polymeric 
material that is intended to be implanted to restore the structure and/
or function of the esophagus. The metal esophageal prosthesis may be 
uncovered or covered with a polymeric material. This device may also 
include a device delivery system.
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance for the Content of Premarket Notification 
Submissions for Esophageal and Tracheal Prostheses.''

[[Page 17146]]

    24. Section 878.3720 is revised to read as follows:


Sec. 878.3720  Tracheal prosthesis.

    (a) Identification. The tracheal prosthesis is a rigid, flexible, 
or expandable tubular device made of a silicone, metal, or polymeric 
material that is intended to be implanted to restore the structure and/
or function of the trachea or trachealbronchial tree. It may be 
unbranched or contain one or two branches. The metal tracheal 
prosthesis may be uncovered or covered with a polymeric material. This 
device may also include a device delivery system.
    (b) Classification. Class II. The special control for this device 
is FDA's ``Guidance for the Content of Premarket Notification 
Submissions for Esophageal and Tracheal Prostheses.''

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

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

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    26. Section 884.1060 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 884.1060  Endometrial aspirator.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (3) The sampling component is covered within vagina.
    27. Section 884.1100 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 884.1100  Endometrial brush.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (3) Design and testing:
    (i) The sampling component is covered within the vagina, and
    (ii) For adherence of the bristles and brush head.
    28. Section 884.1185 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 884.1185  Endometrial washer.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Organization for Standardization's ISO 
10993 `Biological Evaluation of Medical Devices--Part I: Evaluation and 
Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium,
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (iii) Warning: Do not attach to a wall or any external suction, and
    (3) Design and Testing:
    (i) The sampling component is covered within the vagina, and
    (ii) Intrauterine pressure should not exceed 50 millimeters of 
mercury.
    29. Section 884.4100 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 884.4100  Endoscopic electrocautery and accessories.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic 
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2 
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety,''
    (3) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''
    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5 
seconds after the visual endpoint (tissue blanching) is reached or 
current flow ceases indicating adequate tissue destruction.
    30. Section 884.4150 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 884.4150  Bipolar endoscopic coagulator-cutter and accessories.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic 
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2 
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety,''
    (3) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''
    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5 
seconds after the visual endpoint (tissue blanching) is reached or 
current flow ceases indicating adequate tissue destruction.

PART 886--OPHTHALMIC DEVICES

    31. The authority citation for 21 CFR part 886 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    32. Section 886.3400 is revised to read as follows:

[[Page 17147]]

Sec. 886.3400  Keratoprosthesis.

    (a) Identification. A keratoprosthesis is a device intended to 
provide a transparent optical pathway through an opacified cornea, 
either intraoperatively or permanently, in an eye that is not a 
reasonable candidate for a corneal transplant.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Guidance on 510(k) Submissions for Keratoprostheses.''
    33. Section 886.3920 is revised to read as follows:


Sec. 886.3920  Aqueous shunt.

    (a) Identification. An aqueous shunt is an implantable device 
intended to reduce intraocular pressure in the anterior chamber of the 
eye in patients with neurovascular glaucoma or with glaucoma when 
medical and conventional surgical treatments have failed.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Aqueous Shunts--510(k) Submissions.''

PART 888--ORTHOPEDIC DEVICES

    34. The authority citation for 21 CFR part 888 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    35. Section 888.3150 is revised to read as follows:


Sec. 888.3150  Elbow joint metal/polymer constrained cemented 
prosthesis.

    (a) Identification. An elbow joint metal/polymer constrained 
cemented prosthesis is a device intended to be implanted to replace an 
elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, 
or of these alloys and of an ultra-high molecular weight polyethylene 
bushing. The device prevents dislocation in more than one anatomic 
plane and consists of two components that are linked together. This 
generic type of device is limited to those prostheses intended for use 
with bone cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing, ' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,''
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra High Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,''
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (viii) ISO 14630:1997 ``Non-active Surgical Implants--General 
Requirements,''
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 981-93 ``Practice for Assessment of Compatibility of 
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of 
Material on Muscle and Bone,''
    (v) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vi) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium 
Alloy Castings for Surgical Implants,''
    (vii) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings, '' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''
    36. Section 888.3540 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 888.3540  Knee joint patellofemoral polymer/metal semi-constrained 
cemented prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Applications for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,'' and
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,''
    (vii) ISO 7207-2:1998 ``Implants for Surgery--Components for 
Partial and Total Knee Joint Prostheses--Part 2: Articulating Surfaces 
Made of Metal, Ceramic and Plastic Materials,'' and
    (viii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':

[[Page 17148]]

    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for 
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings,''
    (vii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants,'' and
    (viii) F 1672-95 ``Specification for Resurfacing Patellar 
Prosthesis.''
    37. Section 888.3650 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 888.3650  Shoulder joint metal/polymer non-constrained cemented 
prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for 
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings,''
    (vii) F 1378-97 ``Specification for Shoulder Prosthesis,'' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''
    38. Section 888.3660 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 888.3660  Shoulder joint metal/polymer semi-constrained cemented 
prosthesis.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological 
Evaluation of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--
Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-chromium-molybdenum casting alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-chromium-molybdenum alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium 
Alloy Castings for Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal,''
    (vii) F 1378-97 ``Standard Specification for Shoulder Prosthesis,'' 
and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''

    Dated: March 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-7779 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F