[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Rules and Regulations]
[Pages 18540-18542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870 and 886

[Docket No. 99N-0035]


Medical Devices; Reclassification of Six Cardiovascular 
Preamendments Class III Devices into Class II

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying six 
cardiovascular preamendments devices from class III (premarket 
approval) into class II (special controls). FDA is also identifying the 
special controls that the agency believes will reasonably ensure the 
safety and effectiveness of the devices. This reclassification is being 
undertaken on the agency's own initiative based on new information 
under the Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Safe Medical Devices Act of 1990 and the Food and Drug 
Administration Modernization Act of 1997. The agency is also revising 
the identification of one of the devices subject to this rule to 
simplify the classification regulation and is correcting a 
typographical error that was incorporated into the regulations.

DATES: This rule is effective May 10, 2001.

FOR FURTHER INFORMATION CONTACT: Bette L. Lemperle, Center for Devices 
and Radiological Health (HFZ-453), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8262.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 15, 1999 (64 FR 12774), FDA 
published a proposed rule to reclassify 38 preamendments class III 
devices into class II and to establish special controls for these 
devices (the March 1999 proposal). FDA invited interested persons to 
comment on the proposed rule by June 14, 1999. FDA received one request 
to reopen the comment period for six cardiovascular devices. The 
request noted that FDA had not made the guidance documents that were 
proposed as special controls for these six devices available for 
comment through FDA's good guidance practices (GGP's). The requestor 
asked that FDA extend the comment period until at least 90 days after 
the guidance documents were publicly available. In the Federal Register 
of April 19, 2000 (65 FR 20995), FDA announced the availability of six 
guidance documents for these devices and reopened the comment period on 
the reclassification of the six devices (65 FR 20933) until July 18, 
2000.
    FDA received two comments on the vascular graft prosthesis of less 
than 6 millimeters diameter (Sec. 870.3450 (21 CFR 870.3450)). These 
comments are summarized and addressed in section II of this document. 
FDA received no comments on the other five devices. In this final rule, 
FDA is reclassifying the six devices into class II with guidance 
documents as special controls.
    The devices that are being reclassified in this final rule are:
     Vascular graft prosthesis of less than 6 millimeters 
diameter (Sec. 870.3450) (combined with vascular graft prosthesis of 6 
millimeters and greater diameter (Sec. 870.3460 (21 CFR 870.3460)) and 
renamed vascular graft prosthesis)
     Pacemaker lead adaptor (21 CFR 870.3620)
     Annuloplasty ring (21 CFR 870.3800)
     Cardiopulmonary bypass defoamer (21 CFR 870.4230)
     Cardiopulmonary bypass arterial blood line filter (21 CFR 
870.4260)
     Cardiopulmonary bypass oxygenator (21 CFR 870.4350)
    In the Federal Register of March 31, 2000 (65 FR 17138), FDA 
published a final rule to reclassify 28 other preamendments class III 
devices that were included in the March 1999 proposal. That final rule 
included an error in the classification of aqueous shunts (21 CFR 
886.3920). The word ``neurovascular'' was incorrectly used

[[Page 18541]]

for the word ``neovascular.'' FDA is correcting that error in this 
final rule.

II. Comments

    FDA received two comments addressing the vascular graft prosthesis 
of less than 6 millimeters diameter (Sec. 870.3450). Both comments 
supported the reclassification of the device.
    (Comment 1) One comment recommended that vascular graft prostheses 
constructed of materials of animal origin, and instruments, tools, and 
devices used to create vascular graft prostheses should be included in 
the identification of the vascular graft prosthesis of less than 6 
millimeters diameter. The comment stated that the change would reflect 
technological advances made in the medical device industry since the 
device was classified in 1980.
    FDA disagrees with this comment. The identification for the 
vascular graft prosthesis of less than 6 millimeters in diameter 
excludes grafts made of materials of animal origin, including human 
umbilical cords. FDA notes that the biological vascular graft was 
designated as a transitional device and that it was regulated as a drug 
before the vascular graft prosthesis of less than 6 millimeters in 
diameter, a device made of synthetic material, was classified in 1980. 
FDA also notes that the identification of the vascular graft of less 
than 6 millimeters in diameter does not include instruments, tools, and 
other devices used to create vascular prostheses.
    (Comment 2) This comment raised the following five issues:
    1. The comment recommended combining the classification regulations 
of the class III vascular graft prosthesis of less than 6 millimeters 
diameter (Sec. 870.3450) and the class II vascular graft prosthesis of 
6 millimeters and greater diameter (Sec. 870.3460) because separate 
regulations would no longer be necessary if the vascular graft 
prosthesis of less than 6 millimeters is reclassified into class II.
    FDA agrees that it is appropriate to combine the classification 
regulations of the vascular graft prosthesis of less than 6 millimeters 
diameter and the vascular graft prosthesis of 6 millimeters and greater 
diameter into a single device classification. FDA notes that the 
special control guidance document for the vascular graft prosthesis of 
less than 6 millimeters diameter also applies to the vascular graft 
prosthesis of 6 millimeters and greater diameter.
    2. The comment proposed that the reclassification apply to 
indications for use other than those explicitly excluded in the device 
identification.
    FDA disagrees. The revised device identification accurately 
identifies the indications for use of the vascular graft prosthesis 
addressed by the special control guidance document.
    3. The comment included minor editorial changes to the guidance 
document that clarify its meaning.
    FDA agrees with the editorial changes.
    4. The comment proposed to revise the guidance document to reflect 
the revised identification for the vascular graft.
    FDA agrees that the scope of the guidance document should be 
consistent with the revised identification for the device and has 
revised the guidance document accordingly.
    5. The comment recommended that vascular grafts of animal origin, 
and instruments, tools, and devices used to create vascular graft 
prostheses, should not be reclassified into class II.
    As noted above, FDA is not reclassifying vascular grafts of animal 
origin in this final rule. The device identification does not include 
instruments, tools, and other devices used to create vascular graft 
prostheses; FDA is not reclassifying the devices used by physicians to 
create vascular grafts.

III. FDA's Conclusion

    FDA has concluded, based on a review of the available information, 
that the special controls identified below provide reasonable assurance 
of the safety and effectiveness of these six devices. The numbers in 
parentheses are the Facts-on-Demand (FOD) numbers to access copies of 
the guidances identified as the special controls. FOD instructions 
follow the list of guidances.
     Guidance for the Submission of Research and Marketing 
Applications for Permanent Pacemaker Leads and for Pacemaker Lead 
Adaptor 510(k) Submissions (11/1/00) (FOD #372)
     Guidance Document for Vascular Prostheses 510(k) 
Submissions (11/1/00) (FOD #1357)
     Guidance for Annuloplasty Rings 510(k) Submissions (1/31/
00) (FOD #1358)
     Guidance for Extracorporeal Blood Circuit Defoamer 510(k) 
Submissions (11/29/00) (FOD #1632)
     Guidance for Cardiopulmonary Bypass Arterial Line Blood 
Filter 510(k) Submissions (11/29/00) (FOD #1622)
     Guidance for Cardiopulmonary Bypass Oxygenators 510(k) 
Submissions (11/13/00) (FOD #1361)
    To receive these guidance documents via your fax machine, call the 
Center for Devices and Radiological Health (CDRH) FOD system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system and enter the FOD number listed above followed by the pound 
sign (#). Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of these guidance documents 
also may do so by using the Internet. CDRH maintains a site on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with access to the 
Internet. Updated on a regular basis, the CDRH home page includes these 
guidance documents, device safety alerts, Federal Register notices, and 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented issues. The 
CDRH home page may be accessed at http://www.fda.gov/cdrh. These 
guidance documents are also available at http://www.fda.gov/cdrh/ODE.
    The proposed rule identified FDA's biocompatibility and sterility 
guidances as special controls for these six devices. Upon review, we 
have decided not to codify these guidances as special controls for 
these devices. Instead, we are now referencing the sterility and 
biocompatibility guidances within each of the device specific 
guidances. FDA had incorrectly listed the titles of these guidances and 
is correcting the references within the device specific guidances to 
read, ``Use of International Standard ISO-10993 `Biological Evaluation 
of Medical Devices Part I: Evaluation and Testing' '' (FOD #164) and 
``510(k) Sterility Review Guidance (2/12/1990) (#K90-1)'' (FOD #361).

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this final 
rule is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4)). Executive Order 12866 directs agencies

[[Page 18542]]

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 final rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive order and so is not 
subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of these devices from class III 
will relieve all manufacturers of these devices of the cost of 
complying with the premarket approval requirements in section 515 of 
the act (21 U.S.C. 360e). Moreover, compliance with special controls 
proposed for these devices will not impose significant new costs on 
affected manufacturers because most of these devices already comply 
with the 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 final rule will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this proposed rule will not impose costs of $100 
million or more on either the private sector or State, local, and 
tribal governments in the aggregate, and therefore a summary statement 
of analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    FDA concludes that this final 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.

List of Subjects

21 CFR Part 870

    Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

PART 870--CARDIOVASCULAR DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 870.3450 is revised to read as follows:


Sec. 870.3450  Vascular graft prosthesis.

    (a) Identification. A vascular graft prosthesis is an implanted 
device intended to repair, replace, or bypass sections of native or 
artificial vessels, excluding coronary or cerebral vasculature, and to 
provide vascular access. It is commonly constructed of materials such 
as polyethylene terephthalate and polytetrafluoroethylene, and it may 
be coated with a biological coating, such as albumin or collagen, or a 
synthetic coating, such as silicone. The graft structure itself is not 
made of materials of animal origin, including human umbilical cords.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance Document for Vascular Prostheses 510(k) Submissions.''


Sec.  870.3460  [Removed]

    3. Section 870.3460 Vascular graft prosthesis of 6 millimeters and 
greater diameter is removed.
    4. Section 870.3620 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 870.3620  Pacemaker lead adaptor.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for the Submission of Research and Marketing Applications 
for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) 
Submissions.''
    5. Section 870.3800 is amended by revising paragraph (b) and by 
removing paragraph (c) to read as follows:


Sec. 870.3800  Annuloplasty ring.

* * * * *
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for Annuloplasty Rings 510(k) Submissions.''
    6. 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 (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for Extracorporeal Blood Circuit Defoamer 510(k) 
Submissions.''
    7. 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 (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) 
Submissions.''
    8. 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 (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.''

PART 886--OPHTHALMIC DEVICES

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

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


Sec. 886.3920  [Amended]

    10. Section 886.3920 Aqueous shunt is amended in paragraph (a) by 
removing the word ``neurovascular'' and adding in its place the word 
``neovascular''.

    Dated: March 29, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-8829 Filed 4-9-01; 8:45 am]
BILLING CODE 4160-01-S