[Federal Register Volume 64, Number 49 (Monday, March 15, 1999)]
[Proposed Rules]
[Pages 12774-12795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 884, 886, and 
888

[Docket No. 99N-0035]


Medical Devices; Reclassification of 38 Preamendments Class III 
Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify 38 preamendments class III devices into class II (special 
controls). FDA is also identifying the proposed special controls that 
the agency believes will reasonably ensure the safety and effectiveness 
of the devices. This reclassification is being proposed on the agency's 
own initiative based on new information. This action is being taken 
under the Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Safe Medical Devices Act of 1990 (the SMDA) and the FDA 
Modernization Act of 1997 (FDAMA). The agency is also proposing that 
the identification of six of the devices subject to this proposal be 
modified to more accurately reflect the characteristics of devices 
actually being marketed.

DATES: Written comments by June 14, 1999. See section X of this 
document for the proposed effective date of a final rule based on this 
document.

ADDRESSES: Submit written comments to the Documents Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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. Regulatory Authorities

     The act, as amended by the 1976 Medical Device Amendments (the 
amendments) (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and FDAMA 
(Pub. L. 105-115), establishes a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the act (21 U.S.C. 360c) establishes 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 
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 postamendment 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 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, or reclassifies the 
device under 513(f). 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 part 807 of the regulations (21 CFR part 807).
     A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification (510(k)) 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.
     The SMDA added section 515(i) (21 U.S.C. 360e(i)) to the act. This 
section requires FDA to issue an order to manufacturers of preamendment 
class III devices and substantially equivalent postamendments devices 
for which no final regulation requiring the submission of PMA's has 
been issued. This order requires such manufacturers to submit to the 
agency a summary of, and a citation to, any information known or 
otherwise available to them respecting such devices, including adverse 
safety and effectiveness information that has not been submitted under 
section 519 of the act (21 U.S.C. 360i), which requires manufacturers, 
importers, distributors, and device user facilities to submit adverse 
event reports of certain device-related events and reports of certain 
corrective actions taken. Section 515(i) of the act (21 U.S.C. 360e) 
also directs FDA to either revise the classification of the device into 
class I or class II or require the device to remain in class III and 
establish a schedule for the issuance of a rule requiring the 
submission of PMA's for those devices remaining in class III.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced 
the availability of a document setting forth its strategy for 
implementing section 515(i) of the act. Under this plan, the agency 
divided preamendment class III devices into the following three groups: 
Group 1 devices are devices that FDA believes raise significant 
questions of safety and/or effectiveness, but are no longer used or are 
in very limited use; Group 2 devices are devices that FDA believes have 
a high potential for being reclassified; and Group 3 devices are 
devices that FDA believes are currently in commercial distribution and 
are not likely candidates for reclassification. FDA also announced its 
intention to call for submission of PMA's for the 15 highest priority 
devices in Group 3, and for all Group 1 devices. The agency also 
announced its intention to issue an order under section 515(i) of the 
act for the remaining Group 3 devices and for all Group 2 devices.
     In the Federal Register of August 14, 1995 (60 FR 41984 and 
41986), FDA published two orders for certain class III devices, 
requiring the submission of safety and effectiveness information in 
accordance with the preamendments class III strategy for implementing

[[Page 12775]]

section 515(i) of the act. FDA published two updated orders in the 
Federal Register of June 13, 1997 (62 FR 32352 and 32355). The orders 
described in detail the format for submitting the type of information 
required by section 515(i) of the act so that the information submitted 
would clearly support reclassification or indicate that a device should 
be retained in class III. The orders also scheduled the required 
submissions in groups, at 6-month intervals, beginning on August 14, 
1996.
     Reclassification of classified preamendments devices is governed 
by section 513(e) of the act (21 U.S.C. 360c(e)). This section provides 
that FDA may, by rulemaking, reclassify a device 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 (21 U.S.C. 360c(e)), 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 changes in ``medical science.,'' (see 
Upjohn v. Finch, supra, 422 F.2d at 951), or in light of newly 
available regulatory controls (cf. Ethicon, Inc. v. FDA, 762 F. Supp. 
382, 388-389 (D.D.C. 1991)), such as special controls or design 
controls. However, regardless of whether data before the agency are 
past or new data, the ``new information'' on which any reclassification 
is based is required to consist of ``valid scientific evidence,'' as 
defined in section 513(a)(3) of the act (21 U.S.C. 360c(a)(3)) and 
Sec. 860.7(c)(2) (21 CFR 860.7(c)(2)). FDA relies upon ``valid 
scientific evidence'' in the classification process to determine the 
level of regulation for devices.

 II. Regulatory History of the Devices

     The 38 devices subject to this proposal were classified by final 
rules published in the Federal Register in parts 864, 866, 868, 870, 
872, 874, 876, 878, 884, 886, and 888 (21 CFR parts 864, 866, 868, 870, 
872, 874, 876, 878, 884, 886, and 888). In the proposed rules upon 
which the final rules were based, FDA considered the recommendations of 
the device classification advisory panels regarding the classification 
of preamendments medical devices. Subsequently, FDA classified the 
devices subject to this proposal into class III, because there was 
insufficient information to determine that class I or class II controls 
could provide reasonable assurance of the safety and effectiveness of 
these devices. The Federal Register citations and publication dates for 
the proposed and final rules classifying the devices subject to this 
proposal are provided in Table 1. as follows:

Table 1.--Publication Dates for the Proposal and Final Rules Classifying
                  the Devices Subject to This Proposal
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 21 CFR Part and Device       Proposed Rule             Final Rule
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Part 864, Hematology/    September 11, 1979, 44   September 12, 1980, 45
 Pathology                FR 52950                 FR 60576
Part 866, Immunology/    April 22, 1980, 45 FR    November 9, 1982, 47
 Microbiology             27204                    FR 50283
Part 868,                November 2, 1979, 44 FR  July 16, 1982, 47 FR
 Anesthesiology           63292                    31130
Part 870,                March 9, 1979, 44 FR     February 5, 1980, 45
 Cardiovascular           13284                    FR 7904
Part 872, Dental         December 30, 1980, 45    August 12, 1987, 52 FR
                          FR 85962                 30082
Part 874, Ear, Nose,     January 22, 1982, 47 FR  November 6, 1986, 51
 and Throat               3280                     FR 40389
Part 876,                January 23, 1981, 46 FR  November 23, 1983, 48
 Gastroenterology/        7562                     FR 53012
 Urology
Part 878, General and    January 19, 1982, 47 FR  June 24, 1988, 53 FR
 Plastic Surgery          2810                     23856
Part 884, Obstetrical    April 3, 1979, 44 FR     February 26, 1980, 45
 and Gynecological        19894                    FR 12682
Part 886, Ophthalmic     January 26, 1982, 47 FR  September 2, 1987, 52
                          3694                     FR 33346
Part 888, Orthopedic     July 2, 1982, 47 FR      September 4, 1987, 52
                          29052                    FR 33686
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    In accordance with section 513(e) of the act and Sec. 860.130 (21 
CFR 860.130), based upon new information received or otherwise 
available to the agency with respect to the devices subject to this 
proposal, FDA, on its own initiative, is proposing to reclassify 38 
preamendments class III devices to class II. Consistent with the act 
and the regulation, FDA did not refer the proposed reclassifications to 
the panels for their recommendations on the requested change in 
classifications.

 III. Proposed Changes to Device Names and Identifications

     Since initial classification of the 38 devices subject to this 
proposal, there have been many advances in the medical device industry. 
These advances have led to many changes, including the use of 
alternative materials, and/or modifications of the intended uses for 
some devices. Because the changes have been of sufficiently low impact 
on safety and effectiveness, FDA determined that the modified devices 
were substantially equivalent to the respective predicate devices. In 
some cases, however, the substantially equivalent device differs 
slightly from the device description found in the agency's regulations. 
In order to more accurately reflect the characteristics of the actual 
marketed devices subject to this proposal, the agency is proposing 
certain technical amendments be made to six device identifications, as 
listed in section III of this document. The agency stresses that these 
amendments are not intended to impose any additional restrictions on 
the marketed devices; rather, they are intended to accurately reflect 
the characteristics of marketed devices. The following changes in 
device identifications are being proposed.

 A. Section 876.5860--High Permeability Hemodialysis System

     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, and hemoconcentration. Using 
a hemodialyzer with a semipermeable membrane that is more permeable to 
water than the semipermeable membrane of the conventional hemodialysis 
system described in Sec. 876.5820, the high permeability hemodialysis 
system removes toxins or excess fluid from the patient's blood

[[Page 12776]]

using the principles of convection (via a high ultrafiltration rate) 
and/or diffusion (via a concentration gradient in dialysate). During 
treatment, blood from the patient is circulated 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 12 milliliters 
per hour per millimeters of mercury (mL/h/mmHg), and is used with 
either an automated ultrafiltration controller or another 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. Section 878.3610--Esophageal Prosthesis

     An esophageal prosthesis is a rigid, flexible, or expandable 
tubular device constructed 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.

 C. Section 878.3720--Tracheal Prosthesis

     A tracheal prosthesis is a rigid, flexible, or expandable tubular 
device constructed of a silicone, metal, or polymeric material that is 
intended to be implanted to restore the structure and/or function of 
the trachea or tracheal-bronchial 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.

 D. Section 886.3400--Keratoprosthesis

     A keratoprosthesis is a device intended to provide a transparent 
optical pathway through an opacified cornea, either intraoperatively or 
permanently, in an eye which is not a reasonable candidate for a 
corneal transplant.
     This identification recognizes the temporary use of the device 
intraoperatively, and removes the description of the device as being 
made of only plastic material.

 E. Section 886.3920--Aqueous Shunt (previously ``Eye valve implant'')

     An aqueous shunt is a one-way, pressure sensitive device intended 
to be implanted to normalize intraocular pressure. The device is 
intended to treat neurovascular glaucoma or glaucomas where medical and 
conventional surgical treatment have failed
     The agency is proposing that the name of this device be ``aqueous 
shunt'' rather than ``eye valve implant,'' because certain marketed 
devices, which have been determined to be substantially equivalent to 
the eye valve implant, do not contain a valve or a valve-like 
component.
     The agency is also proposing to modify the identification of this 
device to more accurately reflect the device's actual use. Because the 
identified use of ``treatment of glaucoma'' is unnecessarily broad, the 
agency proposes that the identification state that the device may be 
used for the treatment of neovascular glaucoma or glaucomas where 
medical and conventional surgical treatment have failed.

 F. Section 888.3150--Elbow Joint Metal/Polymer Constrained Cemented 
Prosthesis

     An elbow joint metal/polymer constrained cemented prosthesis is a 
device intended to be implanted made of alloys such as cobalt-chromium-
molybdenum and of an ultra-high molecular weight polyethylene bushing, 
and used to replace an elbow joint. The device presents dislocation in 
more than one anatomic plane and consists of two components which are 
linked together. This generic type of device is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
     The agency is proposing that the name and identification of the 
elbow joint metal/metal or metal/polymer constrained cemented 
prosthesis be modified to remove reference to the metal/metal 
prosthesis, because no metal/metal constrained cemented elbow 
prosthesis has ever been marketed.

 IV. Proposed Reclassification

     FDA is proposing that the devices subject to this proposal be 
reclassified from class III to class II. FDA believes that the 
identified special controls would provide reasonable assurance of 
safety and effectiveness. Therefore, in accordance with sections 513(e) 
and 515(i) of the act and Sec. 860.130, based on new information with 
respect to the devices, FDA, on its own initiative, is proposing to 
reclassify these 38 preamendments class III devices into class II. The 
agency has identified special controls that would provide reasonable 
assurance of their safety and effectiveness. The agency does not intend 
to exempt these proposed class II devices from premarket notification 
(510(k)) submissions as provided for under section 510(m) of the act 
(21 U.S.C. 360(m)).

 V. Proposed Special Controls.

     Because several of the special controls identified in this 
proposal apply to 2 or more of the 38 devices addressed by this 
proposal, the agency has determined that it would be inefficient and 
redundant to individually identify, for each device, shared risks to 
health and corresponding special controls to address the risks to 
health. Instead, this document focuses on the special controls, 
explains the types of risks to health addressed by the special 
controls, and identifies the devices to which the special controls 
apply. For ease of review, Table 1 is included in section VI of this 
document following the discussion of special controls. The summary 
table identifies each device by name and Code of Federal Regulations 
(CFR) citation section number, the citation for the final rule which 
classified the preamendments device into Class III, and the proposed 
special controls applicable to the device. The special controls 
identified in this proposal are of four general types: FDA guidance 
documents, consensus standards, device specific labeling, and design 
and performance testing.

 A. FDA Guidance Documents

     Based on its premarket and postmarket experience and the published 
literature, the agency has developed the guidance documents in section 
V.A of this document that are designed to inform manufacturers of

[[Page 12777]]

how the agency evaluates the safety and effectiveness of devices and 
reaches determinations of substantial equivalence. The guidance 
documents are also intended for use by FDA reviewers to ensure 
consistency of premarket reviews. Some FDA guidance documents are 
generic guidances applicable to many different devices, while others 
are applicable to a few related devices, or a specific device. The 
generic guidance documents may be referenced, and thereby incorporated 
into, other guidances.
     The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). When FDA issues a final rule based on this proposal, all of the 
guidance documents identified as special controls will have been issued 
in accordance with GGP's.
     Persons interested in obtaining a copy of a guidance may do so 
using the World Wide Web (WWW). The Center for Devices and Radiological 
Health (CDRH) maintains an entry on the WWW for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the WWW. The CDRH home page may 
be accessed at http://www.fda.gov/cdrh. Guidance documents are also 
available from the Division of Small Manufacturers' Assistance (HFZ-
220), Food and Drug Administration, Center for Devices and Radiological 
Health, 1350 Piccard Dr., Rockville, MD 20850.
     FDA guidances are periodically updated as new information becomes 
available. When an FDA guidance that has been identified as a special 
control is revised, a notice of availability of the revised guidance 
will be published in the Federal Register, as well as a proposal to 
amend the special control(s) for the relevant device(s) to include the 
revised guidance. The following is a list and description of guidance 
documents that FDA proposes to use as special controls:
1. Use of International Standard ISO 10993, ``Biological Evaluation of 
Medical Devices Part I: Evaluation and Testing'' (biocompatibility 
guidance)
     During the classification of the preamendments devices, the device 
classification panels (the panels) identified potential adverse tissue 
reactions as a risk to health common to devices that contact the body. 
These adverse tissue reactions were identified generally, or more 
specifically according to the type of tissue reaction (e.g., 
sensitization, pyrogen reaction, hemolysis, etc.). The agency believes 
that the information contained in this biocompatibility guidance is 
adequate to control the risks to health related to adverse tissue 
reaction.
     Therefore, the agency is proposing that the biocompability 
guidance be a special control applied to the following 27 devices: 
Indwelling blood carbon dioxide partial pressure (PCO2) 
analyzer (Sec. 868.1150), indwelling blood hydrogen ion concentration 
(pH) analyzer (Sec. 868.1170), indwelling blood oxygen partial pressure 
(PO2) analyzer (Sec. 868.1200), cardiovascular intravascular 
filter (Sec. 870.3375), vascular graft prosthesis of less than 6-
millimeters diameter (Sec. 870.3450), pacemaker lead adaptor 
(Sec. 870.3620), annuloplasty ring (Sec. 870.3800), cardiopulmonary 
bypass defoamer (Sec. 870.4230), cardiopulmonary bypass arterial line 
blood filter (Sec. 870.4260), cardiopulmonary bypass oxygenator 
(Sec. 870.4350), OTC (over-the-counter) denture cushion or pad 
(Sec. 872.3540), OTC denture reliner (Sec. 872.3560), OTC denture 
repair kit (Sec. 872.3570), partially fabricated denture kit 
(Sec. 872.3600), high permeability hemodialysis system (Sec. 876.5860), 
peritoneo-venous shunt (Sec. 876.5955), endometrial aspirator 
(Sec. 884.1060), endometrial brush (Sec. 884.1100), endometrial washer 
(Sec. 884.1185), endoscopic electrocautery and accessories 
(Sec. 884.4100), bipolar endoscopic coagulator-cutter and accessories 
(Sec. 884.4150), keratoprosthesis (Sec. 886.3400), aqueous shunt 
(Sec. 886.3920), elbow joint metal/polymer constrained cemented 
prosthesis (Sec. 888.3150), knee joint patellofemoral polymer/metal 
semi-constrained cemented prosthesis (Sec. 888.3540), shoulder joint 
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and 
shoulder joint metal/polymer semi-constrained cemented prosthesis 
(Sec. 888.3660).
2. ``510(k) Sterility Review Guidance and Revision of 11/18/94 K90-1 
(Sterility Guidance)''
     During the classification of the preamendments devices, the panels 
identified potential infection as a risk to health common to the use of 
many devices. The potential risk of infection would be minimized if the 
device were properly sterilized prior to use and appropriately labeled. 
Since classification of the devices subject to this proposal, the 
agency has developed the sterility guidance. It provides information 
about the use and application of national and international sterility 
consensus standards for devices to be labeled as ``sterile.'' The 
agency believes that the information contained in this guidance 
document is adequate to control for the potential risks to health 
related to infection.
     Therefore, the agency is proposing that the sterility guidance be 
a special control for the following 23 devices: Indwelling blood carbon 
dioxide partial pressure (PCO2) analyzer (Sec. 868.1150), 
indwelling blood hydrogen ion concentration (pH) analyzer 
(Sec. 868.1170), indwelling blood oxygen partial pressure 
(PO2) analyzer (Sec. 868.1200), cardiovascular intravascular 
filter (Sec. 870.3375), vascular graft prosthesis of less than 6-
millimeters diameter (Sec. 870.3450), pacemaker lead adaptor 
(Sec. 870.3620), annuloplasty ring (Sec. 870.3800), cardiopulmonary 
bypass defoamer (Sec. 870.4230), cardiopulmonary bypass arterial line 
blood filter (Sec. 870.4260), cardiopulmonary bypass oxygenator 
(Sec. 870.4350), electrohydraulic lithotriptor (Sec. 876.4480), 
peritoneo-venous shunt (Sec. 876.5955), endometrial aspirator 
(Sec. 884.1060), endometrial brush (Sec. 884.1100), endometrial washer 
(Sec. 884.1185), endoscopic electrocautery and accessories 
(Sec. 884.4100), bipolar endoscopic coagulator-cutter and accessories 
(Sec. 884.4150), keratoprosthesis (Sec. 886.3400), eye valve implant 
(Sec. 886.3920), elbow joint metal/polymer constrained cemented 
prosthesis (Sec. 888.3150), knee joint patellofemoral polymer/metal 
semi-constrained cemented prosthesis (Sec. 888.3540), shoulder joint 
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and 
shoulder joint metal/polymer semi-constrained cemented prosthesis 
(Sec. 888.3660).
3. ``Guidance Document for the Submission of Erythropoietin Assay 
Premarket Notification (510(k))''
     During the classification of the preamendments devices, the 
Hematology and Pathology Devices Classification Panel identified as 
risks to health, complications associated with misdiagnosis of a 
disease state. Since classification of this device, the agency has 
developed a guidance document describing its present conclusions 
regarding the materials, labeling, and testing controls for 
erythropoietin assay devices. Because the agency believes that the 
information contained in this guidance document is adequate to control 
for the identified risks to health, the agency is proposing that the 
``Guidance Document for the Submission of Erythropoietin Assay 
Premarket Notification (510(k))'' be a special control for the 
erythropoietin assay (Sec. 864.7250).
4. ``Guidance Document for the Submission of Fibrin Monomer 
Paracoagulation Test Premarket Notification (510(k))''

[[Page 12778]]

     During the classification of the preamendments devices, the 
Hematology and Pathology Devices Classification Panel identified as 
risks to health associated with the use of this device, complications 
associated with misdiagnosis of a disease state. Since classification 
of this device, the agency has developed a guidance document describing 
its present conclusions regarding the materials, labeling, and testing 
controls for fibrin monomer paracoagulation test devices. Because the 
agency believes that the information contained in this guidance 
document is adequate to control for the identified risks to health, the 
agency is proposing that the ``Guidance Document for the Submission of 
Fibrin Monomer Paracoagulation Test Premarket Notifications (510(k))'' 
be a special control for the fibrin monomer paracoagulation test 
(Sec. 864.7300).
5. ``Reviewer Guidance for Clinical Studies and Labeling for Indwelling 
Blood Gas Analyzers''
     During the classification of the preamendments devices, the 
Anesthesiology and Respiratory Therapy Device Classification Panel 
identified as a risk to health common to indwelling blood gas 
analyzers, the potential for inaccurate measurement which would lead to 
inappropriate therapy. Since their classification, the agency has 
developed a guidance document describing its present conclusions 
regarding the appropriate clinical testing to ensure that indwelling 
blood gas analyzers function properly, and labeling which would ensure 
that the devices would be used properly, thus minimizing the risk of 
inaccurate measurement of blood gasses. Because the agency believes 
that the information contained in this guidance document, in 
combination with the guidances described below, is adequate to address 
the risks to health, the agency is proposing that the ``Reviewer 
Guidance for Clinical Studies and Labeling for Indwelling Blood Gas 
Analyzers'' be a special control for the following three devices: 
Indwelling blood carbon dioxide partial pressure (PCO2) 
analyzer (Sec. 868.1150), indwelling blood hydrogen ion concentration 
(pH) analyzer (Sec. 868.1170), and indwelling blood oxygen partial 
pressure (PO2) analyzer (Sec. 868.1200).
     To further minimize the risk of inaccurate measurement by 
indwelling blood gas analyzers, the agency is proposing that the 
``Reviewer Guidance for Computer Controlled Medical Devices Undergoing 
510(k) Review and the Reviewer Guidance for Format and Content of 
Premarket Notifications (510(k) Submissions), Labeling, Performance and 
Environmental Testing for Electronic Devices'' be special controls for 
the following three devices: Indwelling blood carbon dioxide partial 
pressure (PCO2) analyzer (Sec. 868.1150), indwelling blood 
hydrogen ion concentration (pH) analyzer (Sec. 868.1170), and 
indwelling blood oxygen partial pressure (PO2) analyzer 
(Sec. 868.1200). These guidance documents provide more details about 
the agency's present conclusions regarding testing, labeling, and 
manufacturing information which would be required for premarket 
notifications (510(k)) for these device. The agency believes that these 
guidance documents are adequate to address the identified risk to 
health.
6. ``Guidance Document for the Submission of 510(k) Premarket 
Notifications for Cardiovascular Intravascular Filters''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health the following potential complications associated with the use of 
the cardiovascular intravascular filter: Pulmonary thromboembolism when 
anticoagulants are contraindicated, failure of anticoagulant therapy in 
thromboembolic diseases, chronic recurrent pulmonary embolism where 
anticoagulant therapy has failed or is contraindicated. Since 
classification of this device, the agency has developed a guidance 
document describing its present conclusions regarding the labeling, 
biocompatibility testing, mechanical testing, sterilization procedures 
and labeling, and clinical data controls that would ensure the safety 
and effectiveness of cardiovascular intravascular filters seeking 
510(k) clearance. Because the agency believes that the information 
contained in this guidance document is adequate to control for the 
identified risks to health, the agency is proposing that the ``Guidance 
Document for the Submission of 510(k) Premarket Notifications for 
Cardiovascular Intravascular Filters'' be a special control for the 
cardiovascular intravascular filter (Sec. 870.3375).
 7. ``Document for Special Controls for Vascular Prostheses''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health associated with the use of the vascular prosthesis, the 
potentials for: Thrombosis, embolism, occlusion stenosis, leakage, 
graft disruption, seroma, pseudoaneurisms, aneurisms, dilation, 
infection, and device failure. Since classification of this device, the 
agency has established certain labeling, testing, and manufacturing 
controls to minimize the potential of the identified risks to health. 
These controls are discussed in this guidance document. Because the 
agency believes that the information contained in this guidance 
document is adequate to address the identified risks to health, the 
agency is proposing that the ``Document for Special Controls for 
Vascular Prostheses'' be a special control for the vascular graft 
prosthesis of less than 6-millimeters diameter (Sec. 870.3450).
 8. ``Document for Special Controls for Annuloplasty Rings''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as a risk to 
health associated with the use of the annuloplasty ring, the potentials 
for: Stenosis, thrombosis, thromboembolism, regurgitation, ring 
fracture, obstruction, low cardiac output, ring dehiscence, 
endocarditis, bleeding, blockage, and suture injury. Since 
classification of this device, the agency has established certain 
labeling, testing, and manufacturing controls to minimize the potential 
of the identified risks to health. These controls are discussed in this 
guidance document. Because the agency believes that the information 
contained in this guidance document is adequate to address the 
identified risks to health, the agency is proposing that the ``Document 
for Special Controls for Annuloplasty Rings'' be a special control for 
the annuloplasty ring (Sec. 870.3800).
 9. ``Document for Special Controls for the Cardiopulmonary Bypass 
Defoamer''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health associated with the use of the cardiopulmonary bypass defoamer, 
the potentials for: Blood damage, gaseous embolism, thromboembolism, 
blood incompatibility, and inadequate blood flow. Since classification 
of this device, the agency has established labeling, testing, and 
manufacturing controls to minimize the potential of the identified 
risks to health. These controls are discussed in this guidance 
document. Because the agency believes that the information contained in 
this guidance document is adequate to control for the identified risks 
to health, the agency is proposing that the ``Document for Special 
Controls for the Cardiopulmonary Bypass Defoamer'' be a special control 
for the cardiopulmonary bypass defoamer (Sec. 870.4230).

[[Page 12779]]

 10. ``Document for Special Controls for the Cardiopulmonary Bypass 
Arterial Filter''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health associated with the use of the cardiopulmonary bypass arterial 
filter, the potentials for: Gaseous embolism, thromboembolism, blood 
incompatibility, and inadequate blood flow. Since classification of 
this device, the agency has established certain labeling, testing, and 
manufacturing controls to minimize the potential of the identified 
risks to health. These controls are discussed in this guidance 
document. Because the agency believes that the information contained in 
this guidance document is adequate to control for the identified risks 
to health, the agency is proposing that the ``Document for Special 
Controls for the Cardiopulmonary Bypass Arterial Filter'' be a special 
control for the cardiopulmonary bypass arterial line blood filter 
(Sec. 870.4260).
 11. ``Information for Manufacturers Seeking Marketing Clearance for 
Blood-Gas Exchangers (Oxygenators) Used in Cardiopulmonary Bypass''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health associated with the use of the cardiopulmonary bypass 
oxygenator, the potentials for: Failure, improper gas transfer 
function, hemolysis, destruction of platelets and white blood cells, 
sludging, leaking, and emboli formation. Since classification of this 
device, the agency has developed a guidance document describing its 
present conclusions regarding the testing, labeling, and manufacturing 
controls that would be necessary to ensure the safety and effectiveness 
of the cardiopulmonary bypass oxygenator. The controls are discussed in 
this guidance document. Because the agency believes that the 
information contained in this guidance document is adequate to control 
for the identified risks to health, the agency is proposing that the 
``Information for Manufacturers Seeking Marketing Clearance for Blood-
Gas Exchangers'' be a special control for the cardiopulmonary bypass 
oxygenator (Sec. 870.4350).
 12. ``Guidance Document for the Submission of Research and Marketing 
Applications for Permanent Pacemaker Leads''
     During the classification of the preamendments devices, the 
Circulatory System Devices Classification Panel identified as risks to 
health associated with the use of the pacemaker lead adaptor, improper 
pacing, failure to pace, and tissue damage. Since classification of 
this device, the agency has developed a guidance document describing 
its present conclusions regarding the research and marketing 
information which should be submitted to the agency to support 510(k) 
clearance for pacemaker lead adaptors. Because the agency believes that 
the information contained in this guidance document is adequate to 
control for the identified risk to health, the agency is proposing that 
the ``Guidance Document for the Submission of Research and Marketing 
Applications for Permanent Pacemaker Leads'' be a special control for 
the pacemaker lead adaptor (Sec. 870.3620).
 13. ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits''
     During the classification of the preamendments devices, the Dental 
Product Classification Panel identified as risks to health common to 
the use of certain denture accessories, complications resulting from an 
alteration of the vertical dimension of a patient's jaw and irritation 
of oral tissues. Since classification of these devices, the agency has 
developed a guidance document describing its present conclusions 
regarding procedures to minimize the risk of such complications. 
Because the agency believes that the information contained in this 
guidance document is adequate to control for the identified risks to 
health, the agency is proposing that the ``OTC Denture Reliners, Repair 
Kits, and Partially Fabricated Denture Kits'' be a special control for 
the following four devices: OTC denture cushion or pad (Sec. 872.3540), 
OTC denture reliner (Sec. 872.3560), OTC denture repair kit 
(Sec. 872.3570), and partially fabricated denture kit (Sec. 872.3600).
 14. ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket 
Notification''
     During the classification of the preamendments devices, the Ear, 
Nose, and Throat Devices Classification Panel identified as risks to 
health associated with the use of the tympanostomy tube with 
semipermeable membrane, the potentials for hearing loss or premature 
extrusion. Since classification of this device, the agency has 
developed a guidance document describing its present conclusions 
regarding the labeling, testing, and manufacturing information which 
should be submitted to the agency to support 510(k) clearance for 
tympanostomy tubes. Because the agency believes that the information 
contained in this guidance document is adequate to control for the 
identified risks to health, the agency is proposing that the document 
titled ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket 
Notification'' be a special control for the tympanostomy tube with 
semipermeable membrane (Sec. 874.3930).
 15. ``Guidance for the Content of Premarket Notifications for 
Intracorporal Lithotripters''
    During the classification of the preamendments devices, the 
Gastroenterology-Urology Devices Classification Panel identified as 
risks to health associated with the use of the electrohydraulic 
lithotripter, potential: Infection, tissue damage, failure, breakage, 
bleeding, pain, renal damage, and the formation of new stones. Since 
classification of this device, the agency has developed a guidance 
document describing its present conclusions regarding the labeling, 
testing, and manufacturing information which should be submitted to the 
agency to support 510(k) clearance for lithotripters. Because the 
agency believes that the information contained in the guidance 
document, when coupled with the guidance document described below, is 
adequate to control for the identified risks to health, the agency is 
proposing that the ``Guidance for the Content of Premarket 
Notifications for Intracorporeal Lithotripters'' be a special control 
for the electrohydraulic lithotripter (Sec. 876.4480).
     To further minimize the potential risk of infection associated 
with the reuse of electrohydraulic lithotripters, the agency believes 
that certain labeling regarding the reuse of the device is appropriate. 
The agency has developed a guidance document describing its present 
conclusions regarding the labeling for certain reusable devices. FDA is 
also proposing that the guidance document entitled ``Labeling Reusable 
Medical Devices for Reprocessing in Health Care Facilities: FDA 
Reviewer Guidance'' be a special control for the electrohydraulic 
lithotripter (Sec. 876.4480).
 16. ``Guidance for the Content of 510(k)s for Conventional and High 
Permeability Hemodialyzers, Guidance for Industry and CDRH Reviewers on 
the Content of Premarket Notifications for Hemodialysis Delivery 
Systems, Guidance for the Content of Premarket Notifications for Water 
Purification Components and Systems for Hemodialysis, and Guidance for 
Hemodialyzer Reuse Labeling''
     During the classification of the preamendments devices, the 
Gastroenterology-Urology Devices Classification Panel identified as 
risks to health associated with the use of the high permeability 
hemodialysis system,

[[Page 12780]]

potential infection, electrical injury, adverse tissue reaction, 
pyrogen reaction, hemolysis, electrolyte imbalance, hypovolemic shock, 
air embolisms, loss of protein, and blood loss. Since classification of 
this device, the agency has developed four guidance documents 
describing its present conclusions regarding the labeling, testing, and 
manufacturing information which should be submitted to the agency to 
support 510(k) clearance for hemodialysis devices and accessories. 
Because the agency believes that the information contained in the 
guidance documents is adequate to control for the identified risks to 
health, the agency is proposing that these four guidance documents be 
applied as special controls for the high permeability hemodialysis 
system (Sec. 876.5860).
 17. ``Guidance for the Content of Premarket Notification Submissions 
for Esophageal and Tracheal Prostheses''
     During the classification of the preamendments devices, the 
General and Plastic Surgery Devices Classification Panel and the Ear, 
Nose, and Throat Devices Classification Panel identified as potential 
risks to health common to the use of the esophageal prosthesis and the 
tracheal prosthesis, certain complications resulting from migration, 
obstruction, or placement of the devices, and potential gastric reflux 
associated with the use of the esophageal prosthesis. Since 
classification of these devices, the agency has developed a guidance 
document describing its present conclusions regarding the labeling, 
biocompatibility testing, mechanical testing, sterilization procedures 
and labeling, and clinical data controls for esophageal or tracheal 
prostheses seeking 510(k) clearance. Because the agency believes that 
the information contained in this guidance document is adequate to 
control for the identified risks to health, the agency is proposing 
that the ``Guidance for the Content of Premarket Notification 
Submissions for Esophageal and Tracheal Prostheses'' be a special 
control for the following two devices: Esophageal prosthesis 
(Sec. 878.3610) and tracheal prosthesis (Sec. 878.3720).
 18. ``Guidance for Evaluation of Laproscopic Bipolar and Thermal 
Coagulators (and Accessories)''
     During the classification of the preamendments devices, the 
Obstetrical and Gynecological Devices Classification Panel identified 
potential complications from use in pregnant women as a risk to health 
associated with the use of endoscopic electrocautery. Since 
classification of these devices, the agency has developed a document 
which provides information for the evaluation of laproscopic and 
bipolar thermal coagulators. Among the information contained in this 
document, is a discussion of the agency's present conclusions regarding 
the labeling, testing, and manufacturing of such devices. Because the 
agency believes that the information contained in the document is 
adequate to control for the identified risk to health, the agency is 
proposing that the ``Guidance for Evaluation of Laproscopic Bipolar and 
Thermal Coagulators (and Accessories)'' be a special control for the 
endoscopic electrocautery and accessories (Sec. 884.4100) and the 
bipolar endoscopic coagulator-cutter and accessories (Sec. 884.4150).
 19. ``Keratoprosthesis Guidance Document''
     During the classification of the preamendments devices, the 
Ophthalmic Devices Classification Panel identified as risks to health 
associated with keratoprostheses, potentials for extrusion, infection, 
adverse tissue reaction, glaucoma, retinal detachment, and development 
of a retroprosthetic membrane. Since classification of this device, the 
agency has developed a guidance document describing its present 
conclusions regarding the labeling, testing, and manufacturing 
information which should be submitted to the agency to support 510(k) 
clearance for keratoprosthesis devices. Because the agency believes 
that the information contained in the guidance document is adequate to 
control for the identified risks to health, the agency is proposing 
that the ``Keratoprosthesis Guidance Document'' be a special control 
for the keratoprosthesis (Sec. 886.3400).
 20. ``Aqueous Shunt-510(k) Submission''
     During the classification of the preamendments devices, the 
Ophthalmic Devices Classification Panel identified as risks to health 
associated with aqueous shunts, the potentials for hypotony, extrusion, 
infection, adverse tissue reaction, misplacement, migration, and 
failure to filter. Since classification of these devices, the agency 
has developed a guidance document describing its present conclusions 
regarding the labeling, testing, and manufacturing information to be 
submitted to the agency to support 510(k) clearance for aqueous shunts. 
Because the agency believes that the information contained in the 
guidance document is adequate to control for the identified risks to 
health, the agency is proposing that the ``Aqueous Shunt-510(k) 
Submission'' be a special control for the eye valve implant 
(Sec. 886.3920).
 21. ``Guidance Document for Testing Orthopedic Implants with Modified 
Metallic Surfaces Apposing Bone or Bone Cement, Guidance Document for 
Testing Non-articulating, Mechanically Locked' Modular Implant 
Components and Guidance Document for the Preparation of Premarket 
Notification (510(k) Applications for Orthopedic Devices''
     During the classification of the preamendments devices, the 
Orthopedic and Rehabilitation Devices Classification Panel identified 
as risks to health common to the use of certain orthopedic implants, 
the potential for: Pain, loss of joint function, adverse tissue 
reaction, infection, and device failure. Since classification of these 
devices, the agency has provided more information about the agency's 
present conclusions regarding the labeling, testing, and manufacturing 
information required for 510(k) clearance of orthopedic devices, the 
agency has also developed the guidance document titled ``Guidance 
Document for the Preparation of Premarket Notification (510(k)) 
Application for Orthopedic Devices.'' Because the information contained 
in these guidance documents will help minimize the risks to health, the 
agency is proposing that these guidances be applied as a special 
control for the following four devices: Elbow joint metal/polymer 
constrained cemented prosthesis (Sec. 888.3150), knee joint 
patellofemoral polymer/metal semi-constrained cemented prosthesis 
(Sec. 888.3540), shoulder joint metal/polymer nonconstrained cemented 
prosthesis (Sec. 888.3650), and shoulder joint metal/polymer semi-
constrained cemented prosthesis (Sec. 888.3660).

 B. Consensus Standards

     FDA has a long history of participating in the development of 
consensus standards relating to the safety and effectiveness of medical 
devices. These consensus standards are developed by independent 
standards organizations based upon discussions among experts from 
industry, the agency, and other interested parties, and after a series 
of ballots on draft and final documents. Consensus standards define 
terminology, describe test methods, and set performance limits for a 
given product or products. The agency believes that conformity with a 
consensus standard helps to ensure acceptable quality and performance 
of the device to which the standard is applied. The use of standards 
helps to ensure the safety and effectiveness of the devices to which 
the consensus standards apply, and it helps to

[[Page 12781]]

minimize the potential risks to health associated with the use of these 
devices.
     Section 204 of FDAMA amended section 514 of the act (21 U.S.C. 
360d) to allow the agency to recognize consensus standards established 
by international and national standards development organizations for 
use in certain regulatory decision making concerning devices. On 
February 25, 1998 (63 FR 9561), FDA issued a notice of availability of 
a guidance entitled ``Guidance on the Recognition and Use of Consensus 
Standards'' and also published in that document a list of the consensus 
standards that FDA was recognizing for use in the premarket review 
process. FDA will update this list at least annually.
     Consensus standards are periodically updated as new information 
becomes available. When a consensus standard that has been identified 
as a special control is revised, the agency will publish in the Federal 
Register a proposal to amend the special controls for the relevant 
devices to include the revised consensus standard.
     Accordingly, the agency is proposing that the following consensus 
standards be adopted as special controls for the devices identified:
1. American Society for Testing and Materials (ASTM) Standards
     These standards may be obtained from ASTM Customer Services, 100 
Barr Harbor Dr., West Conshohocken, PA 19428 (Telephone 610-832-9585). 
ASTM also maintains a site on the WWW at the address ``http://
www.astm.org''.
     a. The following standard is proposed as a special control for the 
cutaneous oxygen monitor (21 CFR 868.2500) ASTM F984-86: 
``Specification for Cutaneous Gas Monitoring Devices for Oxygen and 
Carbon Dioxide.''
     b. The following seven standards are proposed as special controls 
for the elbow joint metal/polymer constrained cemented prosthesis 
(Sec. 888.3150), the knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis (Sec. 888.3540), the shoulder joint 
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and 
the shoulder joint metal/polymer semi-constrained cemented prosthesis 
(Sec. 888.3660):
     (1) ASTM F75-92 ``Specification for Cast Cobalt-Chromium-
Molybdenum Alloy for Surgical Implant Material,''
     (2) STM F799-96 ``Specification for Cobalt-28 Chromium-6 
Molybdenum Alloy Forgings for Surgical Implants,''
     (3) ASTM F1108-97 ``Specification for Ti6Al4V Alloy Castings for 
Surgical Implants,''
     (4) ASTM F648-96 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
     (5) ASTM F1537-94 ``Specification for Wrought Cobalt-Chromium-
Molybdenum Alloy for Surgical Implants,''
     (6) ASTM 1044 ``Test Method for Shear Testing of Porous Metal 
Coatings,'' and
     (7) ASTM 1147 ``Test Method for Tension Testing of Porous Metal 
Coatings.''
     c. The following standards are proposed as special controls for 
the knee joint patellofemoral polymer/metal semi-constrained cemented 
prosthesis (Sec. 888.3540):
     (1) ASTM F370-94 ``Specification for Proximal Femoral 
Prosthesis,''
     (2) ASTM F1672-95 ``Specification for Resurfacing Patellar 
Prosthesis,'' and
     (3) ASTM F1223-96 ``Test Method for Determination of Total Knee 
Replacement Constraint.''
     d. The following standard is proposed as a special control for the 
elbow joint metal/polymer constrained cemented prosthesis 
(Sec. 888.3150) ASTM 981: ``Practice for Assessment of Compatibility of 
Biomaterials for Surgical Implant with Respect to Effect of Material on 
Muscle and Bone.''
     e. The following standard is proposed as a special control for the 
shoulder joint metal/polymer nonconstrained cemented prosthesis 
(Sec. 888.3650), and the shoulder joint metal/polymer semi-constrained 
cemented prosthesis (Sec. 888.3660) ASTM 1378: ``Specification for 
Shoulder Prosthesis.''
 2. American National Standards Institute/American Association for 
Medical Instrumentation (ANSI/AAMI)
     These standards may be obtained from ANSI/AAMI, 11 West 42d St., 
New York, NY 10036. ANSI also maintains a site on the world wide web at 
``http://www.ansi.org''. FDA proposes the following ANSI/AAMI standards 
as special controls for the identified devices:
     a. ANSI/AAMI DF2 ``Cardiac Defibrillator Devices'' as applied to 
the external transcutaneous cardiac pacemaker (noninvasive) (21 CFR 
870.5550);
     b. ANSI/AAMI/ISO 11135 ``Medical Devices-Validation and Routine 
Control of Ethylene Oxide Sterilization'' as applied to the peritoneo-
venous shunt (Sec. 876.5955); and
     c. ANSI/AAMI HF-18 ``Electrosurgical Devices'' as applied to the 
endoscopic electrocautery and accessories (Sec. 884.4100), the bipolar 
endoscopic coagulator-cutter and accessories (Sec. 884.4150), and the 
electrohydraulic lithotriptor (Sec. 876.4480).
 3. International Standards Organization (ISO).
     These standards may be obtained from International Organization 
for Standardization, Case Postale, Geneva, Switzerland, CH-1121. ISO 
also maintains a site on the world wide web at ``http://www.iso.org''.
     a. FDA proposes the following ISO standards as special controls 
for the elbow joint metal/polymer constrained cemented prosthesis 
(Sec. 888.3150), the knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis (Sec. 888.3540), the shoulder joint 
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and 
the shoulder joint metal/polymer semi-constrained cemented prosthesis 
(Sec. 888.3660):
     (1) ISO 5832 ``Implants for Surgery-Metallic Materials;''
     (2) ISO 5833 ``Implants for Surgery-Acrylic Resin Cements;'' and
     (3) ISO 5834 ``Implants for Surgery-Ultra High Molecular Weight 
Polyethylene;''
     (4) ISO 9001 ``Quality Systems-Model for Quality Assurance in 
Design/Development, Production, Installation, and Servicing;'' and
     (5) ISO 6018 ``General Requirements for Marketing, Packaging, and 
Labeling.''
     b. The following ISO standard is proposed as a special control for 
the elbow joint metal/polymer constrained cemented prosthesis 
(Sec. 888.3150): ISO 14630 ``Non-active Surgical Implants-General 
Requirements.''
     c. The following ISO standard is proposed as a special control for 
the knee joint patellofemoral polymer/metal semi-constrained cemented 
prosthesis (Sec. 888.3540): ISO 7207 ``Implants for Surgery-Femoral and 
Tibial Components for Partial and Total Knee Joint Prostheses.''
 4. National Committee for Clinical Laboratory Standards (NCCLS)
     Copies of these standards may be obtained from NCCLS Executive 
Offices, 940 West Valley Rd., suite 1400, Wayne, PA 19087 (Telephone 
610-688-0100). NCCLS also maintains a site on the WWW at ``http://
www.nccls.org''.
     a. FDA proposes the following NCCLS standards as special controls 
for the rubella virus serological reagents (Sec. 866.3510):
     (1) NCCLS I/LA6 ``Evaluation and Performance Criteria for Multiple 
Component Test Products Intended for the Detection and Quantitation of 
Rubella IgG Antibody,''

[[Page 12782]]

     (2) NCCLS D13 ``Agglutination Characteristics, Methodology, 
Limitations, and Clinical Validation,''
     (3) NCCLS I/LA18 ``Specifications for Immunological Testing for 
Infectious Diseases,''
     (4) NCCLS EP5 ``Evaluation of Precision Performance of Clinical 
Chemistry Devices,'' and
     (5) NCCLS EP10 ``Preliminary Evaluation of Quantitative Clinical 
Laboratory Methods-Second edition, 1993.''
     b. FDA proposes the following NCCLS standards as special controls 
for the indwelling blood carbon dioxide partial pressure 
(PCO2) analyzer (Sec. 868.1150), the indwelling blood 
hydrogen ion concentration (pH) analyzer (Sec. 868.1170), and the 
indwelling blood oxygen partial pressure (PO2) analyzer 
(Sec. 868.1200):
     (1) NCCLS EP5 ``Evaluation of Precision Performance of Clinical 
Chemistry Devices,''
     (2) NCCLS EP6 ``Evaluation of the Linearity of Quantitive 
Analytical Methods,''
     (3) NCCLS EP7 ``Interference Testing in Clinical 
Chemistry''(PO2) analyzer (21 CFR 868.1200),
     (4) NCCLS EP9 ``User Comparison of Quantitative Clinical 
Laboratory Methods Using Patient Samples,'' and
     (5) NCCLS EP10 ``Preliminary Evaluation of Quantitative Clinical 
Laboratory Methods-Second edition, 1993.''
 5. International Electrotechnical Commission (IEC)
     Copies of these standards may be obtained from IEC, AT3, Rue de 
Varembe, P.O. Box 131, Geneva, Switzerland, ch-1211. IEC also maintains 
a site on the WWW at ``http://www.iec.ch''.
     a. FDA proposes the following IEC standard as special controls for 
the indwelling blood carbon dioxide partial pressure (PCO2) 
analyzer (Sec. 868.1150), the indwelling blood hydrogen ion 
concentration (pH) analyzer (Sec. 868.1170), the indwelling blood 
oxygen partial pressure (PO2) analyzer (Sec. 868.1200), the 
electrohydraulic lithotripter (Sec. 876.4480), the endoscopic 
electrocautery and accessories (Sec. 884.4100), and the bipolar 
endoscopic coagulator-cutter and accessories (Sec. 884.4150): IEC 60601 
``Electrical Safety Standard.''
     b. FDA also proposes the following IEC standard as a special 
control for the cutaneous oxygen monitor (Sec. 868.2500), and the 
airbrush (Sec. 872.6080): IEC 601 ``Medical Device Electrical 
Standard.''
 6. Underwriters Laboratory (UL)
     These standards may be obtained from Underwriters Laboratories, 
Inc., 333 Pfingsten Rd., Northbrook, IL 60062 (Telephone 847-272-8800). 
UL also maintains a site on the WWW at ``http://www.ul.com''.
     FDA proposes the following standard as a special control for the 
cutaneous oxygen monitor (Sec. 868.2500): UL 2601-1 ``Standard for 
Safety, Medical Electrical Equipment, Part 1: General Requirements for 
Safety.''
 7. The International Federation of Clinical Chemistry (IFCC)
     These standards may be obtained from IFCC through their site on 
the WWW at ``http://www.leeds.ac.uk/ifcc''.
     FDA proposes the following standard as a special control for the 
cutaneous oxygen monitor (Sec. 868.2500): ``IFCC Guidelines for 
Transcutaneous PO2 and PCO2 Measurement.''
 8. Centers for Disease Control and Prevention (CDC)
     CDC has developed standards associated with the detection or 
prevention of disease. These standards may be obtained from the Center 
for Disease Control and Prevention, Mail Stop G18, 1600 Clifton Rd., 
NE., Atlanta, GA 30333.
     FDA proposes the following CDC standards as special controls for 
the rubella virus serological reagents (Sec. 866.3510):
     (1) ``CDC Low Titer Rubella Standard'' as applied to
     (2) ``CDC Reference Panel of Well Characterized Rubella Sera.''
 9. World Health Organization International (WHO)
     WHO has also developed standards associated with the detection or 
prevention of disease. These standards may be obtained from the 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. FDA proposes the following as a special control for the 
identified device proposed for reclassification: ``WHO Rubella 
Standard'' as applied to rubella virus serological reagents 
(Sec. 866.3510).
 C. Device-specific Labeling
     When considering the preamendments devices, the panels identified 
certain risks to health which would result from the improper use of a 
device, or use in improper circumstances. The agency believes that 
general labeling controls such as adequate directions for use, as 
required by section 502(f) of the act (21 U.S.C. 352(f)), and the 
labeling requirements for medical devices in 21 CFR part 801, and for 
in vitro diagnostic products at 21 CFR 809.10 minimize the potential 
for most identified risks to health.
     However, the agency recognizes that, for certain devices, the 
general labeling requirements are not sufficiently specific to 
adequately address and minimize specifically identified risks to 
health. These risks may be addressed by a more specific labeling 
regulation (e.g., 21 CFR part 801, subpart H), by guidance, or by 
issuing specific labeling as a special control. Indeed, several of the 
FDA guidance documents, which have been identified in this proposal as 
special controls, contain a section on device labeling. For other 
devices, no device-specific labeling is addressed in regulations or FDA 
guidance, although the agency believes that device-specific labeling 
would be an appropriate special control. Labeling is being proposed as 
a special control for the following devices:
     1. Tinnitus masker (Sec. 874.3400)
     The agency is proposing that the professional labeling of this 
device contain patient information that describes the risks, benefits, 
warnings for safe use, and technical specifications of the device in 
terminology understandable to the average layman. Patient information 
would also include recommending that the patient seek medical 
consultation to determine the cause of tinnitus, fitting of the device, 
and followup care by a hearing health care professional.
     2. Tympanostomy tube with semipermeable membrane (Sec. 874.3930)
     The agency is proposing that the labeling for this device describe 
the risk of clogging, and state that the device is intended for use 
only in ears that have been evacuated.
     3. Endometrial aspirator (Sec. 884.1060), endometrial brush 
(Sec. 884.1100), and endometrial washer (Sec. 884.1185)
     The agency is proposing that the labeling for these devices state 
that the device is only intended as an adjunctive tool to evaluate the 
endometrium, and that it is contraindicated in cases of pregnancy, 
history of uterine perforation, and recent cesarean section. 
Furthermore, the agency is proposing that the labeling of the 
endometrial washer (Sec. 884.1185) also contain a statement warning 
that the device should not be attached to wall or any external suction.
     4. Endoscopic electrocautery and accessories (Sec. 884.4100) and 
bipolar endoscopic coagulator-cutter and accessories (Sec. 884.4150)
     The agency is proposing that the labeling of these devices: 
Contain an indication for use statement: ``for female tubal 
sterilization,'' contain instructions for use that recommend 
destruction of at least 2 cm of the fallopian tube, use of a ``cut'' 
(or undamped sinusoidal)

[[Page 12783]]

waveform, and use of minimum power of 25 watts. For devices that have 
ammeters, the labeling must state that activation of electrode is 
recommended for 4 to 5 seconds after the visual endpoint is reached or 
current flow ceases, to achieve complete destruction of tissue.
     D. Design and Performance Testing.
     The agency has often relied upon consensus standards for the 
establishment of design specifications for medical devices. For certain 
devices for which neither consensus standards nor FDA guidances are 
available to address critical design or performance criteria, the 
agency believes it is appropriate to identify design specifications and 
performance testing as a special control. Accordingly, design 
specifications and performance testing are proposed as special controls 
for the following devices:
 1. External transcutaneous cardiac pacemaker (noninvasive) 
(Sec. 870.5550)
     The agency is proposing that this device shall not have the 
capability of delivering pulses in excess of 200 microamperes with a 
width less than or equal to 50 milliseconds.
 2. Tympanostomy tube with semipermeable membrane (Sec. 874.3930)
     The agency is proposing that the membrane material be 
polytetrafluoroethylene (PTFE) sheeting with no more than a 1-micron 
pore size and 0.003-inch thickness. Furthermore, the agency is 
proposing to require functional testing of these devices to verify air 
passage.
 3. Peritoneo-venous shunt (Sec. 876.5955)
     The agency is proposing that these devices provide a specification 
for backflow that ensures against excessive reflux of blood into the 
shunt. Furthermore, the agency is proposing that these devices undergo 
pyrogenicity testing using either the U.S. Pharmacopeia (USP) Rabbit 
Pyrogen Test or USP Bacterial Endotoxins Test.
 4. Endometrial aspirator (Sec. 884.1060), endometrial brush 
(Sec. 884.1100), and endometrial washer (Sec. 884.1185)
     The agency is proposing that these devices be designed such that 
the sampling part of the device is covered while entering and leaving 
the vagina. Furthermore, the agency is proposing that the endometrial 
brush (Sec. 884.1100) be tested to demonstrate adequate adherence of 
bristles and brush head, and the endometrial washer (Sec. 884.1185) 
undergo testing to demonstrate that maximum intrauterine pressure does 
not exceed 50 millimeters of mercury.

 VI. Summary of Special Controls

[[Page 12784]]



                                                                    Table  2.--Summary of Special Controls Listed by Device1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 FDA Sterility Review     FDA Biocompatibility                                                                               Design Controls,
     CFR Section            Device Name                Guidance                 Guidance           Other FDA Guidance1           Labeling                Standards          Performance Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
864.7250............  Erythropoietin assay                                                       1
864.7300............  Fibrin monomer                                                             2
                       paracoagulation test
866.3510............  Rubella virus                                                                                                               NCCLS\2\ 1/LA6; 1/
                       serological reagents                                                                                                        LA18; D13; EP5; EP10;
                                                                                                                                                  CDC\3\ Low Titer
                                                                                                                                                   Rubella Standard;
                                                                                                                                                  WHO\4\ Rubella
                                                                                                                                                   Standard;
                                                                                                                                                  CDC Reference Panel of
                                                                                                                                                   Well Characterized
                                                                                                                                                   Rubella Sera
868.1150............  Indwelling blood carbon  X                        X                        3, 4, 5                                          NCCLS standards,
                       dioxide partial                                                                                                            EP5,
                       pressure (PCO2)                                                                                                            EP6,
                       analyzer                                                                                                                   EP7,
                                                                                                                                                  EP9,
                                                                                                                                                  EP10,
                                                                                                                                                  IEC\5\ 60601
868.1170............  Indwelling blood         X                        X                        3, 4, 5                                          NCCLS standards,
                       hydrogen ion                                                                                                               EP5,
                       concentration (pH)                                                                                                         EP6,
                       analyzer                                                                                                                   EP7,
                                                                                                                                                  EP9,
                                                                                                                                                  EP10,
                                                                                                                                                  IEC 60601
868.1200............  Indwelling blood oxygen  X                        X                        3, 4, 5                                          NCCLS standards,
                       partial pressure (PO2)                                                                                                     EP5,
                       analyzer                                                                                                                   EP6,
                                                                                                                                                  EP7,
                                                                                                                                                  EP9,
                                                                                                                                                  EP10,
                                                                                                                                                  IEC 60601
868.2500(b).........  Cutaneous oxygen                                                                                                            ASTM\6\ F984-86,
                       monitor                                                                                                                    IEC 601,
                                                                                                                                                  UL\7\ 2601-1,
                                                                                                                                                  IFCC\8\ Guidelines for
                                                                                                                                                   Transcutaneous PO2
                                                                                                                                                   and PCO2 Measurement
870.3375............  Cardiovascular           X                        X                        6
                       intravascular filter
870.3450............  Vascular graft           X                        X                        7
                       prosthesis of less
                       than 6 millimeters
                       diameter
870.3620............  Pacemaker lead adaptor   X                        X                        8
870.3800............  Annuloplasty ring        X                        X                        9

[[Page 12785]]

 
870.4230............  Cardiopulmonary bypass   X                        X                        10
                       defoamer
870.4260............  Cardiopulmonary bypass   X                        X                        11
                       arterial line blood
                       filter
870.4350............  Cardiopulmonary bypass   X                        X                        12
                       oxygenator
870.5550............  External transcutaneous                                                                                                     ANSI/AAMI\9\ DF-2       Shall not have
                       cardiac pacemaker                                                                                                                                   capability of
                       (noninvasive)                                                                                                                                       delivering pulses in
                                                                                                                                                                           excess of 200
                                                                                                                                                                           milliamperes with a
                                                                                                                                                                           width less than or
                                                                                                                                                                           equal to 50
                                                                                                                                                                           milliseconds
872.3540............  OTC denture cushion or                            X                        13
                       pad
872.3560............  OTC denture reliner                               X                        13
872.3570............  OTC denture repair kit                            X                        13
872.3600............  Partially fabricated                              X                        13
                       denture kit
872.6080............  Airbrush                                                                                                                    IEC-601
874.3400............  Tinnitus masker                                                                                     Patient labeling re:
                                                                                                                           medical consultation,
                                                                                                                           fitting and follow-up
                                                                                                                           care by a hearing
                                                                                                                           health care
                                                                                                                           professional, risks,
                                                                                                                           benefits, warnings
                                                                                                                           for safe use, and
                                                                                                                           technical
                                                                                                                           specifications
874.3930............  Tympanostomy tube with                                                     14                       Risk of clogging                                Functional testing to
                       semipermeable membrane                                                                              described,                                      verify air passage.
                                                                                                                          Only for use in ears                            Membrane material:
                                                                                                                           that have been                                  PTFE\10\ sheeting;
                                                                                                                           evacuated                                       1.0 micron pore size;
                                                                                                                                                                           0.003 inch thickness
876.4480............  Electrohydraulic         X                                                 15, 16                                           ANSI/AAMI HF-18
                       lithotriptor                                                                                                               IEC 60601
876.5860............  High permeability                                 X                        17, 18, 19, 20
                       hemodialysis system
876.5955............  Peritoneo-venous shunt   X                        X                                                                         Sterilization           Pyrogeni-city testing
                                                                                                                                                   validation per ANSI/    per USP Rabbit
                                                                                                                                                   AAMI/ISO\11\ 11135      Pyrogen Test or USP
                                                                                                                                                                           Bacterial Endotoxins
                                                                                                                                                                           Test,
                                                                                                                                                                          Backflow
                                                                                                                                                                           specifications that
                                                                                                                                                                           ensure against
                                                                                                                                                                           excessive reflux of
                                                                                                                                                                           blood into the shunt
878.3610............  Esophageal prosthesis                                                      21
878.3720............  Tracheal prosthesis                                                        21

[[Page 12786]]

 
884.1060............  Endometrial aspirator    X                        X                                                 Only for use as an                              Device design to
                                                                                                                           adjunctive tool to                              ensure that the
                                                                                                                           evaluate the                                    sampling part is
                                                                                                                           endometrium;                                    covered while
                                                                                                                          Contraindications:                               entering and leaving
                                                                                                                           pregnancy, history of                           vagina
                                                                                                                           uterine perforation,
                                                                                                                           and recent cesarean
                                                                                                                           section
884.1100............  Endometrial brush        X                        X                                                 Only for use as an                              Device design so that
                                                                                                                           adjunctive tool to                              the sampling part is
                                                                                                                           evaluate the                                    covered within the
                                                                                                                           endometrium;                                    vagina,
                                                                                                                          Contraindication:                               Testing to demonstrate
                                                                                                                           pregnancy, history of                           adequate adherence of
                                                                                                                           uterine perforation,                            bristles and brush
                                                                                                                           and recent cesarean                             head
                                                                                                                           section
884.1185............  Endometrial washer       X                        X                                                 Only for use as an                              Testing to demonstrate
                                                                                                                           adjunctive tool to                              that maximum
                                                                                                                           evaluate the                                    intrauterine pressure
                                                                                                                           endometrium;                                    should not exceed 50
                                                                                                                          Device should not be                             millimeters of
                                                                                                                           attached to wall or                             mercury;
                                                                                                                           any external suction;                          Device design so that
                                                                                                                          Contraindications:                               the sampling part is
                                                                                                                           Pregnancy, history of                           covered within vagina
                                                                                                                           uterine perforation,
                                                                                                                           and recent cesarean
                                                                                                                           section
884.4100............  Endoscopic               X                                                 22                       Indication: female      IEC 60601 ANSI/AAMI HF-
                       electrocautery and                                                                                  tubal sterilization;    18
                       accessories                                                                                        Treatment
                                                                                                                           instructions:
                                                                                                                           ``destruction of at
                                                                                                                           least 2 cm of
                                                                                                                           tube,''; use of a
                                                                                                                           cut' (or undamped
                                                                                                                           sinusoidal) waveform,
                                                                                                                           and minimum power of
                                                                                                                           25 watts;
                                                                                                                          For devices with
                                                                                                                           ammeters: activation
                                                                                                                           of electrode for 4 to
                                                                                                                           5 seconds

[[Page 12787]]

 
884.4150............  Bipolar endoscopic       X                                                 22                       Indication: female                              IEC 60601 or ANSI/AAMI
                       coagulator-cutter                                                                                   tubal sterilization;                            HF-18
                                                                                                                          Treatment
                                                                                                                           instructions:
                                                                                                                           ``destruction of at
                                                                                                                           least 2 centimeters
                                                                                                                           of tube,''; use of a
                                                                                                                           cut' (or undamped
                                                                                                                           sinusoidal) waveform,
                                                                                                                           and minimum power of
                                                                                                                           25 watts;
                                                                                                                          For devices with
                                                                                                                           ammeters: activation
                                                                                                                           of electrode for 4 to
                                                                                                                           5 seconds
886.3400............  Keratoprosthesis         X                        X                        23
886.3920............  Eye valve implant        X                        X                        24
888.3150............  Elbow joint metal/       X                        X                        25, 26, 27                                       ASTM F75-92, F799-96,
                       polymer constrained                                                                                                         F1108-97, F648-96,
                       cemented prosthesis                                                                                                         F1537-94, F981,
                                                                                                                                                   F1044, F1147;
                                                                                                                                                  ISO 5832, 5833, 5834,
                                                                                                                                                   14630, 10993, 9001,
                                                                                                                                                   6018
888.3540............  Knee joint               X                        X                        25, 26, 27                                                               ASTM F75-92, F799-96,
                       patellofemoral polymer/                                                                                                                             F1108-97, F648-96,
                       metal semi-constrained                                                                                                                              F1537-94, F1044,
                       cemented prosthesis                                                                                                                                 F1147, F1223-96, F370-
                                                                                                                                                                           94; F1672-95
                                                                                                                                                                          ISO 5832, 5833, 5834,
                                                                                                                                                                           6018, 7207, 9001
888.3650............  Shoulder joint metal/    X                        X                        25, 26, 27                                                               ASTM F75-92, F799-96,
                       polymer non-                                                                                                                                        F1108-97, F648-96,
                       constrained cemented                                                                                                                                F1537-94, F1044,
                       prosthesis                                                                                                                                          F1147, F1378;
                                                                                                                                                                          ISO 5832, 5833, 5834,
                                                                                                                                                                           6018, 9001
888.3660............  Shoulder joint metal/    X                        X                        25, 26, 27                                       ASTM F75-92, F799-96,
                       polymer semi-                                                                                                               F1108-97, F648-96,
                       constrained cemented                                                                                                        F1537-94, F1044,
                       prosthesis                                                                                                                  F1147, F1378;
                                                                                                                                                  ISO 5832, 5833, 5834,
                                                                                                                                                   6018, 9001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The following is a list of guidances FDA has developed to inform manufactures of how the agency evaluates the safety and effectiveness of devices and reaches determination of substantial
  equivalency:
(1) ``Guidance Document for the Submission of Erythropoietin Assay Premarket Notification (510(k)),''
(2) ``Guidance Document for the Submission of Fibrin Monomer Paracoagulation Test Premarket Notification (510(k)),''
(3)``Reviewer Guidance for Clinical Studies and Labeling for Indwelling Blood Gas Analyzers,''
(4) ``Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,''
(5) ``Reviewer Guidance for Format and Content of Premarket Notifications (510(k) Submissions): Labeling, Performance and Environmental Testing for Electronic Devices,''
(6) ``Guidance Document for the Submission of 510(k) Premarket Notifications for Cardiovascular Intravascular Filters,''
(7) ``Document for Special Controls for Vascular Prostheses,''

[[Page 12788]]

 
(8) ``Guidance Document for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads,''
(9) ``Document for Special Controls for the Cardiopulmonary Bypass Defoamer,''
(10) ``Document for Special Controls for the Cardiopulmonary Bypass Arterial Filter,''
(11) ``Information for Manufacturers Seeking Marketing Clearance for Blood-Gas Exchangers (Oxygenators) Used in Cardiopulmonary Bypass,''
(12) ``Document for Special Controls for Annuloplasty Rings,''
(13) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits,''
(14) ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification,''
(15) ``Guidance for the Content of Premarket Notifications for Intracorporal Lithotripters,''
(16) ``Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance,''
(17) ``Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,''
(18) ``Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,''
(19) ``Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,''
(20) ``Guidance for Hemodialyzer Reuse Labeling,''
(21) ``Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses,''
(22) ``Guidance for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),''
(23) ``Keratoprosthesis Guidance Document,''
(24) ``Aqueous Shunt-510(k) Submission,''
(25) ``Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(26) ``Guidance Document for Testing Non-articulating, Mechanically Locked' Modular Implant Components,'' and
(27) ``Guidance Document for the Preparation of Premarket Notification (510(k) Applications for Orthopedic Devices.''
\2\ National Committee for Clinical Laboratory Standards.
\3\ Centers for Disease Control and Prevention.
\4\ World Health Organization.
\5\ International Electrotechnical Commission.
\6\ American National Standards Institute.
\7\ Underwriters Laboratories.
\8\ International Federation of Clinical Chemistry.
\9\ Association for the Advancement of Medical Instrumentation.
\10\ Polytetrafluoroethylene.
\11\ International Standards Organization.


[[Page 12789]]

 VII. Environmental Impact

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

 VIII. 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 Fairness Act of 
1996 (Pub. L 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 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 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 proposed rule, if issued, 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.

IX. Paperwork Reduction Act of 1995

     FDA tentatively 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.

X. Submission of Comments and Proposed Effective Dates

     Interested persons may, on or before June 14, 1999 submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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 may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.
     FDA proposes that any final regulation that may issue based on 
this proposal becomes effective 30 days after its date of publication 
in the Federal Register.

List of Subjects

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Parts 868, 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, it is 
proposed that 21 CFR parts 864, 866, 868, 870, 872, 874, 876, 878, 884, 
886, and 888 be 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 ``Guidance Document for Submission of Erythropoietin Assay 
Premarket Notification (510(k)).''
    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 ``Guidance Document for Submission of Fibrin Monomer 
Paracoagulation Test Premarket Notification (510(k)).''

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) I/LA6 ``Evaluation and Performance Criteria for Multiple 
Component Test Products Intended for the Detection and Quantitation of 
Rubella IgG Antibody,''
    (ii) 1/LA18 ``Specifications for Immunological Testing for 
Infectious Diseases,''
    (iii) D13 ``Agglutination Characteristics, Methodology, 
Limitations, and Clinical Validation,''
    (iv) EP5 ``Evaluation of Precision Performance of Clinical 
Chemistry Devices,'' and
    (v) EP10 ``Evaluation of the Linearity of Quantitive Analytical 
Methods,''
    (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 868--ANESTHESIOLOGY DEVICES

    6. The authority citation for 21 CFR part 868 continues to read as 
follows:

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

    7. Section 868.1150 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


[[Page 12790]]




Sec. 868.1150  Indwelling blood carbon dioxide partial pressure 
(PCO2) analyzer.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Reviewer Guidance for Computer Controlled Medical Devices 
Undergoing 510(k) Review,''
    (iii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood 
Gas Analyzers,'' and
    (iv) ``Reviewer Guidance for Format and Content of Premarket 
Notifications (510(k) Submissions), Labeling, Performance and 
Environmental Testing for Electronic Devices,''
    (3) National Committee for Clinical Laboratory Standards':
    (i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry 
Devices,''
    (ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical 
Methods,''
    (iii) EP7 ``Interference Testing in Clinical Chemistry,''
    (iv) EP9 ``User Comparison of Quantitative Clinical Laboratory 
Methods Using Patient Samples,'' and
    (v) EP10 ``Preliminary Evaluation of Quantitative Clinical 
Laboratory Methods--Second edition, 1993,'' and
    (4) International Electrotechnical Commission's 60601 ``Electrical 
Safety Standard.''
    8. Section 868.1170 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 868.1170  Indwelling blood hydrogen ion concentration (pH) 
analyzer.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``FDA Reviewer Guidance for Computer Controlled Medical 
Devices Undergoing 510(k) Review,''
    (iii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood 
Gas Analyzers,'' and
    (iv) ``Reviewer Guidance for Format and Content of Premarket 
Notifications (510(k) Submissions), Labeling, Performance and 
Environmental Testing for Electronic Devices,''
    (3) National Committee for Clinical Laboratory Standards':
    (i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry 
Devices,''
    (ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical 
Methods,''
    (iii) EP7 ``Interference Testing in Clinical Chemistry,''
    (iv) EP9 ``User Comparison of Quantitative Clinical Laboratory 
Methods Using Patient Samples,'' and
    (v) EP10 ``Preliminary Evaluation of Quantitative Clinical 
Laboratory Methods--Second edition, 1993,'' and
    (4) International Electrotechnical Commission's 60601 ``Electrical 
Safety Standard.''
    9. Section 868.1200 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 868.1200  Indwelling blood oxygen partial pressure 
(PO2) analyzer.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Reviewer Guidance for Computer Controlled Medical Devices 
Undergoing 510(k),''
    (ii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood 
Gas Analyzers,''
    (iii) ``Reviewer Guidance for Format and Content of Premarket 
Notifications (510(k) Submissions), Labeling, Performance and 
Environmental Testing for Electronic Devices,'' and
    (iv) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-10,''
    (2) National Committee for Clinical Laboratory Standards':
    (i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry 
Devices,''
    (ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical 
Methods,''
    (iii) EP7 ``Interference Testing in Clinical Chemistry,''
    (iv) EP9 ``User Comparison of Quantitative Clinical Laboratory 
Methods Using Patient Samples,'' and
    (v) EP10 ``Preliminary Evaluation of Quantitative Clinical 
Laboratory Methods--Second edition, 1993,''
    (3) International Electrotechnical Commission's 60601 ``Electrical 
Safety Standard,'' and
    (4) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing.''
    10. Section 868.2500 is amended by revising paragraph (b)(2) and by 
removing paragraph (c) to read as follows:

Sec. 868.2500  Cutaneous oxygen monitor.

* * * * *
    (b) * * *
    (2) Classification. Class II. The special controls for this device 
are:
    (i) American Society for Testing and Materials' F984-86 
``Specification for Cutaneous Gas Monitoring Devices for Oxygen and 
Carbon Dioxide,''
    (ii) International Electrotechnical Commission's IEC 601 ``Medical 
Device Electrical Standard,''
    (iii) Underwriters Laboratory's ``Medical Electrical Equipment (UL 
2601-1),'' and
    (iv) The International Federation of Clinical Chemistry's 
``Guidelines for Transcutaneous PO2 and PCO2 
Measurement.''

PART 870--CARDIOVASCULAR DEVICES

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

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

    12. 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) 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 11/18/94 
K90-10,'' and
    (ii) ``Guidance Document for the Submission of 510(k) Premarket 
Notifications for Cardiovascular Intravascular Filters.''
    13. Section 870.3450 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.3450  Vascular graft prosthesis of less than 6 millimeters 
diameter.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) 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 11/18/94 
K90-10,'' and
    (ii) ``Document on Special Controls for Vascular Prostheses.''
    14. Section 870.3620 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.3620  Pacemaker lead adaptor.

* * * * *

[[Page 12791]]

    (b) Classification. Class II. The special controls for this device 
are:
    (1) 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 11/18/94 
K90-1,'' and
    (ii) ``Guidance Document for the Submission of Research and 
Marketing Applications for Permanent Pacemaker Leads.''
    15. Section 870.3800 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.3800  Annuloplasty rings.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,'' and
    (ii) ``Document for Special Controls for Annuloplasty Rings,'' and
    (2) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing.''
    16. Section 870.4230 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.4230  Cardiopulmonary bypass defoamer.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Bluebook Guidance for Sterility, K90-1,''
    (ii) ``Document for Special Controls for Cardiopulmonary Bypass 
Defoamer,'' and
    (2) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing.''
    17. Section 870.4260 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.4260  Cardiopulmonary bypass arterial line blood filter.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Bluebook Guidance for Sterility, K90-1,'' and
    (ii) ``Document for Special Controls for Cardiopulmonary Bypass 
Arterial Filters,'' and
    (2) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing.''
    18. Section 870.4350 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:

Sec. 870.4350  Cardiopulmonary bypass oxygenator.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) 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 11/18/94 
K90-1,'' and
    (ii) ``Information for Manufacturers Seeking Marketing Clearance 
for Blood Gas Exchangers (Oxygenators) Used in Cardiopulmonary 
Bypass.''
    19. 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-2,'' and
    (2) The device shall not have capability of delivering pulses in 
excess of 200 milliamperes with a width less than or equal to 50 
milliseconds.

PART 872--DENTAL DEVICES

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

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

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

Sec. 872.3540  OTC denture cushion or pad.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
    (2) FDA's ``OTC Denture Reliners, Repair Kits, and Partially 
Fabricated Denture Kits.''
    22. 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:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
    (2) FDA's ``OTC Denture Reliners, Repair Kits, and Partially 
Fabricated Denture Kits.''
    23. 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:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
    (2) FDA's ``OTC Denture Reliners, Repair Kits, Partially Fabricated 
Denture Kits.''
    24. 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.

* * * * *
    (b) Classification. Class II. The special controls for this device 
are:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
    (2) FDA's ``OTC Denture Reliners, Repair Kits, Partially Fabricated 
Denture Kits.''
    25. 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-601 ``Medical Device 
Electrical Standard.''

PART 874--EAR, NOSE, AND THROAT DEVICES

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

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

    27. 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 controls for this device 
are:
    (1) Patient labeling to include information about:
    (i) Risks,
    (ii) Benefits,
    (iii) Warnings for safe use, and
    (iv) Technical specifications, and
    (2) Medical consultation for:

[[Page 12792]]

    (i) Determination of the cause of tinnitus,
    (ii) Fitting of the device, and
    (iii) Followup care by a hearing health care professional.
    28. 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 controls for this device 
are:
    (1) FDA's ``Tympanostomy Tubes, Submission Guidance for a 510(k),''
    (2) Functional testing to verify air passage,
    (3) Use of polytetrafluoroethylene sheeting with 1.0 micron pore 
size and 0.003 inch thickness as membrane material, and
    (4) Labeling to:
    (i) Describe risk of clogging, and
    (ii) State that device is only for use in ears that have been 
evacuated.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    29. 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.

    30. 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 controls for this device 
are:
    (1) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Guidance for the Content of Premarket Notifications for 
Intracorporeal Lithotripters,'' and
    (iii) ``Labeling Reusable Medical Devices for Reprocessing in 
Health Care Facilities: FDA Reviewer Guidance,''
    (2) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18 ``Electrosurgical Devices,'' and
    (3) International Electrotechnical Commission's IEC 60601 
``Electrical Safety Standard.''
    31. Section 876.5860 is amended by revising paragraphs (a) and (b) 
and by removing paragraph (c) 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, and hemoconcentration. Using a hemodialyzer with a 
semipermeable membrane that is more permeable to water than the 
semipermeable membrane of the conventional hemodialysis system 
described in 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 12 
milliliters per hour per conventional millimeter of mercury, and is 
used with either an automated ultrafiltration controller or another 
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:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
    (2) FDA's:
    (i) ``Guidance for the Content of 510(k)s for Conventional and High 
Permeability Hemodialyzers,''
    (ii) ``Guidance for Industry and CDRH Reviewers on the Content of 
Premarket Notifications for Hemodialysis Delivery Systems,''
    (iii) ``Guidance for the Content of Premarket Notifications for 
Water Purification Components and Systems for Hemodialysis,'' and
    (iv) ``Guidance for Hemodialyzer Reuse Labeling.''
    32. 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:
    (1) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
    (3) ``Pyrogenicity Testing per USP Rabbit Pyrogen Test or USP 
Bacterial Endotoxins Test,''
    (4) American National Standards Institute/American Association for 
Medical Instrumentation's ANSI/AAMI/ISO 11135 ``Medical Devices--
Validation and Routine Control of Ethylene Oxide Sterilization,'' and
    (5) Specification for backflow that ensures against excessive 
reflux of blood into the shunt.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    33. 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.

    34. Section 878.3610 is amended by revising paragraphs (a) and (b) 
and by removing paragraph (c) to read as follows:

Sec. 878.3610  Esophageal prosthesis.

    (a) Identification. An esophageal prosthesis is a rigid, flexible, 
or expandable tubular device constructed 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

[[Page 12793]]

Notification Submissions for Esophageal and Tracheal Prostheses.''
    35. Section 878.3720 is amended by revising paragraphs (a) and (b) 
and by removing paragraph (c) to read as follows:

Sec. 878.3720  Tracheal prosthesis.

    (a) Identification. The tracheal prosthesis is a rigid, flexible, 
or expandable tubular device constructed 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

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

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

    37. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
    (3) Device design so that sampling part is covered while entering 
or leaving vagina, and
    (4) Labeling to state that the device is only an adjunctive tool to 
evaluate the endometrium and to contraindicate use of device in 
pregnant patients and patients with a history of uterus perforation or 
recent cesarean section.
    38. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
    (3) Device design so that sampling part is covered while entering 
or leaving vagina,
    (4) Testing to demonstrate adequate adherence of bristles and brush 
head, and
    (5) Labeling to state that the device is only an adjunctive tool to 
evaluate the endometrium and to contraindicate use of device in 
pregnant patients and patients with a history of uterus perforation or 
recent cesarean section.
    39. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
    (3) Device design so that sampling part is covered while entering 
or leaving vagina,
    (4) Intrauterine pressure not to exceed 50 conventional millimeters 
of mercury, and
    (5) Labeling to:
    (i) Contraindicate use of the device in pregnant patients and 
patients with a history of uterus perforation or recent cesarean 
section,
    (ii) Warn that the device should not be attached to wall or any 
other external source of suction, and
    (iii) State that the device is only an adjunctive tool to evaluate 
the endometrium.
    40. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``Guidelines for Evaluation of Laproscopic Bipolar and 
Thermal Coagulators,''
    (3) International Electrotechnical Commission's IEC 60601 
``Electrical Safety Standard,''
    (4) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18 ``Electrosurgical Devices,''
    (5) Labeling: an indication for female tubal sterilization,
    (6) Treatment instructions to:
    (i) Destroy at least 2 centimeters of a tube,
    (ii) Use a cut or undampened sinusoidal waveform, and
    (iii) Use a minimum power of 25 watts, and
    (7) Labeling of devices with ammeters to activate the electrode for 
4 to 5 seconds after the visual endpoint is reached or current flow 
ceases for complete destruction of tissue.
    41. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (2) FDA's ``Guidance for Evaluation of Laproscopic Bipolar and 
Thermal Coagulators (and Accessories),''
    (3) International Electrotechnical Commission's IEC 60601 
``Electrical Safety Standard,''
    (4) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18 ``Electrosurgical Devices,''
    (5) Labeling: An indication for female tubal sterilization,
    (6) Treatment instructions to:
    (i) Destroy at least 2 centimeters of a tube,
    (ii) Use a cut or undampened sinusoidal waveform, and
    (iii) Use a minimum power of 25 watts, and
    (7) Labeling of devices with ammeters to activate the electrode for 
4 to 5 seconds after the visual endpoint is reached or current flow 
ceases for complete destruction of tissue.

PART 886--OPHTHALMIC DEVICES

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

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

    43. Section 886.3400 is amended by revising paragraphs (a) and (b) 
and by removing paragraph (c) to read as follows:

Sec. 886.3400  Keratoprosthesis.

    (a) Identification. A keratoprosthesis is a device intended to 
provide a

[[Page 12794]]

transparent optical pathway through an opacified cornea, either 
intraoperatively or permanently, in an eye which is not a reasonable 
candidate for a corneal transplant.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) 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 11/18/94 
K90-1,'' and
    (ii) ``Keratoprosthesis Guidance Document.''
    44. Section 886.3920 is amended by revising the section heading and 
paragraphs (a) and (b) and by removing paragraph (c) to read as 
follows:

Sec. 886.3920  Aqueous shunt.

    (a) Identification. An aqueous shunt is a one-way, pressure 
sensitive device intended to be implanted to normalize intraocular 
pressure. The device is intended to treat neovascular glaucoma or 
glaucomas where medical and conventional surgical treatment have 
failed.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) 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 11/18/94 
K90-1,'' and
    (ii) ``Aqueous Shunts--510(k) Submissions.''

PART 888--ORTHOPEDIC DEVICES

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

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

    46. 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 exclusively 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 which 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (i) ISO 5832 ``Implants for Surgery--Metallic Materials,''
    (ii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
    (iii) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight 
Polyethylene,''
    (iv) ISO 14630 ``Non-active Surgical Implants--General 
Requirements,''
    (v) ISO 10993 ``Biocompatibility Test Methods,''
    (vi) ISO 9001 ``Quality Systems--Model for Quality Assurance in 
Design/Development, Production, Installation, and Servicing,'' and
    (vii) ISO 6018 ``General Requirements for Marketing, Packaging, and 
Labeling.''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iii) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (iv) ``Guidance Document for Testing Non-articulating, 
`Mechanically Locked' Modular Implant Components,'' and
    (3) American Society for Testing and Materials':
    (i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iii) F1108-97 ``Specification for Ti6Al4V Alloy Castings for 
Surgical Implants,''
    (iv) F648-96 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implants,''
    (vi) F981 ``Practice for Assessment of Compatibility of 
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of 
Material on Muscle and Bone,''
    (vii) F1044 ``Test Method for Shear Testing of Porous Metal 
Coatings,'' and
    (viii) F1147 ``Test Method for Tension Testing of Porous Metal 
Coatings.''
    47. 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) International Standards Organization's ISO 10993 ``Biological 
Evaluation of Medical Devices Part I: Evaluation and Testing,''
    (i) ISO 5832 ``Implants for Surgery--Metallic Materials,''
    (ii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
    (iii) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight 
Polyethylene,''
    (iv) ISO 9001 ``Quality Systems--Model for Quality Assurance in 
Design/Development, Production, Installation, and Servicing,''
    (v) ISO 7207 ``Implants for Surgery--Femoral and Tibial Components 
for Partial and Total Knee Joint Prostheses,'' and
    (vi) ISO 6018 ``General Requirements for Marketing, Packaging, and 
Labeling.''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iii) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Applications for Orthopedic Devices,''
    (iv) ``Guidance Document for Testing Non-articulating, 
`Mechanically Locked' Modular Implant Components,'' and
    (3) American Society for Testing and Materials':
    (i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iii) F1108-97 ``Ti6Al4V Alloy Castings for Surgical Implants,''
    (iv) F648-96 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implants,''
    (vi) F1044 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vii) F1147 ``Test Method for Tension Testing of Porous Metal 
Coatings,''
    (viii) F370-94 ``Specification for Proximal Femoral Prosthesis,'' 
and
    (ix) F1672-95 ``Specification for Resurfacing Patellar 
Prosthesis.''

[[Page 12795]]

    48. 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) International Standards Organization's:
    (i) ISO 10993 ``Biological Evaluation of Medical Devices Part I: 
Evaluation and Testing,''
    (ii) ISO 5832 ``Implants for Surgery--Metallic Materials,''
    (iii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
    (iv) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight 
Polyethylene,''
    (v) ISO 9001 ``Quality Systems--Model for Quality Assurance in 
Design/Development, Production, Installation, and Servicing,'' and
    (vi) ISO 6018 ``General Requirements for Marketing, Packaging, and 
Labeling.''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iii) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (iv) ``Guidance Document for Testing Non-articulating, 
`Mechanically Locked' Modular Implant Components,''
    (3) American Society for Testing and Materials':
    (i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iii) F1108-97 ``Ti6Al4V Alloy Castings for Surgical Implants,''
    (iv) F648-96 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implants,''
     (vi) F1044 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vii) F1147 ``Test Method for Tension Testing of Porous Metal 
Coatings,'' and
    (viii) F1378 ``Specification for Shoulder Prosthesis.''
    49. 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) International Standards Organization's:
    (i) ISO 10993 ``Biological Evaluation of Medical Devices Part I: 
Evaluation and Testing,''
    (ii) ISO 5832 ``Implants for Surgery--Metallic Materials,''
    (iii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
    (iv) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight 
Polyethylene,''
    (v) ISO 9001 ``Quality Systems--Model for Quality Assurance in 
Design/Development, Production, Installation, and Servicing,'' and
    (vi) ISO 6018 ``General Requirements for Marketing, Packaging, and 
Labeling,''
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 11/18/94 
K90-1,''
    (ii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iii) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (iv) ``Guidance Document for Testing Non-articulating, 
`Mechanically Locked' Modular Implant Components,'' and
    (3) American Society for Testing and Materials':
    (i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iii) F1108-97 ``Specification for Ti6Al4V Alloy Castings for 
Surgical Implants,''
    (iv) F648-96 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum 
Alloy for Surgical Implants,''
    (vi) F1044 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vii) F1147 ``Test Method for Tension Testing of Porous Metal 
Coatings,'' and
    (viii) F1378 ``Standard Specification for Shoulder Prosthesis.''

    Dated: March 1, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-6266 Filed 3-12-99; 8:45 am]
BILLING CODE 4160-01-F