[Federal Register: November 18, 2003 (Volume 68, Number 222)]
[Proposed Rules]               
[Page 65014-65018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no03-20]                         


[[Page 65014]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868, 870, and 882

[Docket No. 2003N-0468]

 
Medical Devices; Effective Date of Requirement for Premarket 
Approval for Three Class III Preamendments Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in 
classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
the filing of a premarket approval application (PMA) or a notice of 
completion of a product development protocol (PDP) for the following 
three class III preamendments devices: Indwelling blood oxyhemoglobin 
concentration analyzer, cardiopulmonary bypass pulsatile flow 
generator, and the ocular plethysmograph. The agency also is 
summarizing its proposed findings regarding the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring the 
devices to meet the statute's approval requirements and the benefits to 
the public from the use of the devices. In addition, FDA is announcing 
the opportunity for interested persons to request that the agency 
change the classification of any of the devices based on new 
information. This action implements certain statutory requirements.

DATES: Submit written or electronic comments by February 17, 2004. 
Submit requests for a change in classification by December 3, 2003. FDA 
intends that, if a final rule based on this proposed rule is issued, 
anyone who wishes to continue to market the device will need to submit 
a PMA within 90 days of the effective date of the final rule. Please 
see section XII of this document for the effective date of any final 
rule that may publish based on this proposal.

ADDRESSES: Submit written comments or requests for a change in 
classification to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 
94-295) and the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 
101-629), established a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the act (21 
U.S.C. 360c) established three categories (classes) of devices, 
depending on the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously offered devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and 21 CFR part 807.
    Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the 
requirement that a preamendments device that FDA has classified into 
class III is subject to premarket approval. A preamendments class III 
device may be commercially distributed without an approved PMA or a 
notice of completion of a PDP until 90 days after FDA issues a final 
rule requiring premarket approval for the device, or 30 months after 
final classification of the device under section 513 of the act, 
whichever is later. Also, a preamendments device subject to the 
rulemaking procedure under section 515(b) of the act is not required to 
have an approved investigational device exemption (IDE) (see 21 CFR 
part 812) contemporaneous with its interstate distribution until the 
date identified by FDA in the final rule requiring the submission of a 
PMA for the device. At that time, an IDE is required only if a PMA has 
not been submitted or a PDP completed.
    Section 515(b)(2)(A) of the act provides a proceeding to issue a 
final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing: (1) The 
regulation, (2) proposed findings with respect to the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring the 
device to have an approved PMA or a declared completed PDP and the 
benefit to the public from the use of the device, (3) an opportunity 
for the submission of comments on the proposed rule and the proposed 
findings, and (4) an opportunity to request a change in the 
classification of the device based on new information relevant to the 
classification of the device.
    Section 515(b)(2)(B) of the act provides that if FDA receives a 
request for a change in the classification of the device within 15 days 
of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change in 
reclassification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the act. Section 
515(b)(3) of the act provides that FDA shall, after the close of the 
comment period on the proposed rule and consideration of any comments 
received, issue a final rule to require premarket approval, or publish 
a document terminating the proceeding together with the reasons for 
such termination. If FDA terminates the proceeding, FDA is required to 
initiate reclassification of the device under section 513(e) of the 
act, unless the reason for termination is that the device is a banned 
device under section 516 of the act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a 
preamendments device is finalized, section 501(f)(2)(B) of the act (21 
U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a 
PDP for any such device be filed within 90 days of the date of issuance 
of the final rule or 30 months after the final classification

[[Page 65015]]

of the device under section 513 of the act, whichever is later. If a 
PMA or notice of completion of a PDP is not filed by the later of the 
two dates, commercial distribution of the device is required to cease.
    The device may, however, be distributed for investigational use if 
the manufacturer, importer, or other sponsor of the device complies 
with the IDE regulations. If a PMA or notice of completion of a PDP is 
not filed by the later of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of section 
501(f)(1)(A) of the act, and subject to seizure and condemnation under 
section 304 of the act (21 U.S.C. 334) if its distribution continues. 
Shipment of devices in interstate commerce will be subject to 
injunction under section 302 of the act (21 U.S.C. 332), and the 
individuals responsible for such shipment will be subject to 
prosecution under section 303 of the act (21 U.S.C. 333). In the past, 
FDA has requested that manufacturers take action to prevent the further 
use of devices for which no PMA has been filed and may determine that 
such a request is appropriate for the class III devices that are the 
subjects of this regulation.
    The act does not permit an extension of the 90-day period after 
issuance of a final rule within which an application or a notice is 
required to be filed. The House Report on the 1976 amendments states 
that:
    [t]he thirty month `grace period' afforded after classification 
of a device into class III * * * is sufficient time for 
manufacturers and importers to develop the data and conduct the 
investigations necessary to support an application for premarket 
approval (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the act requiring FDA to review 
the classification of preamendments class III devices for which no 
final rule has been issued requiring the submission of PMAs and to 
determine whether or not each device should be reclassified into class 
I or class II or remain in class III. For devices remaining in class 
III, the SMDA directed FDA to develop a schedule for issuing 
regulations to require premarket approval. The SMDA does not, however, 
prevent FDA from proceeding immediately to rulemaking under section 
515(b) of the act on specific devices, in the interest of public 
health, independent of the procedures of section 515(i). Indeed, 
proceeding directly to rulemaking under section 515(b) of the act is 
consistent with Congress' objective in enacting section 515(i), i.e., 
that preamendments class III devices for which PMAs have not been 
required either be reclassified to class I or class II or be subject to 
the requirements of premarket approval. Moreover, in this proposal, 
interested persons are being offered the opportunity to request 
reclassification of any of the devices.
    In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a 
notice of availability of a preamendments class III devices strategy 
document. The strategy set forth FDA's plans for implementing the 
provisions of section 515(i) of the act for preamendments class III 
devices for which FDA had not yet required premarket approval. FDA 
divided this universe of devices into 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. FDA's strategy is to call for PMAs for all group 1 
devices in an omnibus section 515(b) of the act rulemaking action. In 
the Federal Register of September 7, 1995 (60 FR 46718), FDA 
implemented this strategy by proposing requiring the filing of a PMA or 
a notice of completion of a PDP for 43 class III preamendments devices. 
Subsequently, in the Federal Register of September 27, 1996 (61 FR 
50704), FDA called for the filing of a PMA or a notice of completion of 
a PDP for 41 preamendments class III devices.
    Group 2 devices are devices that FDA believes have a high potential 
for being reclassified into class II. In the Federal Registers of 
August 14, 1995 (60 FR 41986), and of June 13, 1997 (62 FR 32355), FDA 
issued an order under section 515(i) of the act requiring manufacturers 
to submit safety and effectiveness information on these group 2 devices 
so that FDA can make a determination as to whether the devices should 
be reclassified.
    Group 3 devices are devices that FDA believes are currently in 
commercial distribution and are not likely candidates for 
reclassification. FDA intends to issue proposed rules to require the 
submission of PMAs for the 15 high priority devices in this group in 
accordance with the schedule set forth in the strategy document. In the 
Federal Registers of August 14, 1995 (60 FR 41984), and of June 13, 
1997 (62 FR 32352), FDA issued an order under section 515(i) of the act 
for the 27 remaining group 3 devices requiring manufacturers to submit 
safety and effectiveness information so that FDA can make a 
determination as to whether the devices should be reclassified or 
retained in class III.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the act, FDA is proposing to 
require that a PMA or a notice of completion of a PDP be filed with the 
agency for class III devices within 90 days after issuance of any final 
rule based on this proposal. An applicant whose device was legally in 
commercial distribution before May 28, 1976, or whose device has been 
found to be substantially equivalent to such a device, will be 
permitted to continue marketing such class III devices during FDA's 
review of the PMA or notice of completion of the PDP. FDA intends to 
review any PMA for the device within 180 days, and any notice of 
completion of a PDP for the device within 90 days of the date of 
filing. FDA cautions that, under section 515(d)(1)(B)(i) of the act, 
the agency may not enter into an agreement to extend the review period 
for a PMA beyond 180 days unless the agency finds that ``* * * the 
continued availability of the device is necessary for the public 
health.''
    FDA intends that, under Sec.  812.2(d) (21 CFR 812.2(d)), the 
preamble to any final rule based on this proposal will state that, as 
of the date on which the filing of a PMA or a notice of completion of a 
PDP is required to be filed, the exemptions in Sec.  812.2(c)(1) and 
(c)(2) from the requirements of the IDE regulations for preamendments 
class III devices will cease to apply to any device that is: (1) Not 
legally on the market on or before that date, or (2) legally on the 
market on or before that date but for which a PMA or notice of 
completion of a PDP is not filed by that date, or for which PMA 
approval has been denied or withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is 
not filed with FDA within 90 days, after the date of issuance of any 
final rule requiring premarket approval for the device, commercial 
distribution of the device must cease. The device may be distributed 
for investigational use only if the requirements of the IDE regulations 
regarding significant risk devices are met. The requirements for 
significant risk devices include submitting an IDE application to FDA 
for its review and approval. An approved IDE is required to be in 
effect before an investigation of the device may be initiated or 
continued. FDA, therefore, cautions that IDE applications should be 
submitted to FDA at least 30 days before the end of the 90-day period 
after the final rule to avoid interrupting investigations.

[[Page 65016]]

III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the act, FDA is publishing its 
proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that these 
devices have an approved PMA or a declared completed PDP, and (2) the 
benefits to the public from the use of the devices.
    These findings are based on the reports and recommendations of the 
advisory committees (panels) for the classification of these devices 
along with any additional information that FDA has discovered. 
Additional information can be found in the following proposed and final 
rules published in the Federal Register on these dates: Anesthesiology 
devices, 21 CFR part 868 (44 FR 63292, November 2, 1979, and 47 FR 
31130, July 16, 1982); cardiovascular devices, 21 CFR part 870 (44 FR 
13284, March 9, 1979 and 45 FR 7903, February 5, 1980); and 
neurological devices, 21 CFR part 882 (43 FR 55639, November 28, 1978, 
and 44 FR 51725, September 4, 1979).

IV. Devices Subject to This Proposal

A. Indwelling Blood Oxyhemoglobin Concentration Analyzer (21 CFR 
868.1120)

1. Identification
    An indwelling blood oxyhemoglobin concentration analyzer is a photo 
electric device used to measure, in vivo, the oxygen carrying capacity 
of hemoglobin in blood to aid in determining the patient's 
physiological status.
2. Summary of Data
    The Anesthesiology Device Classification Panel recommended that the 
indwelling blood oxyhemoglobin concentration analyzer intended to 
measure, in vivo, the oxygen carrying capacity of hemoglobin in blood 
to aid in determining the patient's physiological status be classified 
into class III based on the lack of published clinical data relating to 
the safety of, and the problems associated with this device. FDA agreed 
and continues to agree with the panel's recommendation that the device 
be classified into class III.
3. Risks to Health
    a. Inappropriate therapy--Inaccurate measurement of the blood 
oxyhemoglobin concentration may cause an incorrect diagnosis leading to 
inappropriate therapy.
    b. Thrombus or embolus formulation--If the analyzer materials are 
incompatible with the blood, thrombus or embolus (clot) formation may 
result.
    c. Electrical shock--If the device is not designed properly, the 
patient may receive an electrical shock.
    d. Vascular occlusion--If the device sensor is too large, it may 
occlude the blood vessel in which it is placed, thus stopping the blood 
flow through that vessel.

B. Cardiopulmonary Bypass Pulsatile Flow Generator (21 CFR 870.4320)

1. Identification
    A cardiopulmonary bypass pulsatile flow generator is an 
electrically and pneumatically operated device used to create pulsatile 
blood flow. The device is placed in a cardiopulmonary bypass circuit 
downstream from the oxygenator.
2. Summary of Data
    The Cardiovascular Devices Classification Panel recommended that 
the cardiopulmonary bypass pulsatile flow be classified into class III 
because it is potentially hazardous to life or health even when 
properly used and because there are insufficient data to establish the 
safety and effectiveness of the device. FDA agreed and continues to 
agree with the panel's recommendation. The agency notes that the device 
has fallen into disuse and that the published data are not adequate to 
demonstrate the safety and effectiveness of the device.
3. Risks to Health
    a. Cardiac arrhythmias or electrical shock--Excessive electrical 
leakage current can disturb the normal electrophysiology of the heart, 
leading to the onset of cardiac arrhythmias. Electrical leakage current 
can also cause electrical shock to a physician during a catheterization 
or surgical procedure and this may lead to iatrogenic complications.
    b. Blood damage--If the materials, surface finish, cleanliness, or 
improper mechanical design of this device are inadequate, damage to the 
blood may result.
    c. Thromboembolism--Inadequate blood compatibility of the materials 
used in the device, inadequate surface finish and cleanliness, or 
improper mechanical design may lead to potentially debilitating or 
fatal gas emboli to escape into the bloodstream.

C. Ocular Plethysmograph (21 CFR 882.1790)

1. Identification
    An ocular plethysmograph is a device used to measure or detect 
volume changes in the eye produced by pulsations of the artery, to 
diagnose carotid artery occlusive disease (restrictions on blood flow 
in the carotid artery).
2. Summary of Data
    The Neurological Device Classification Panel recommended that the 
ocular plethysmograph be classified into class III because it is used 
to detect the life-threatening condition that occurs when the brain 
does not receive adequate blood flow through a carotid artery.
3. Risks to Health
    a. Eye injury--Excessive pressure can damage they eye.
    b. Misdiagnosis--The device may misdiagnose the presence or absence 
of carotid artery occlusion because of a poor relationship between 
pulsatile arterial blood flow changes and the degree of occlusion.
    c. Infection--Eye cups that are not sterile can cause infections.

V. PMA Requirements

    A PMA for these devices must include the information required by 
section 515(c)(1) of the act. Such a PMA should also include a detailed 
discussion of the risks identified previously, as well as a discussion 
of the effectiveness of the device for which premarket approval is 
sought. In addition, a PMA must include all data and information on: 
(1) Any risks known, or that should be reasonably known, to the 
applicant that have not been identified in this document; (2) the 
effectiveness of the device that is the subject of the application; and 
(3) full reports of all preclinical and clinical information from 
investigations on the safety and effectiveness of the device for which 
premarket approval is sought.
    A PMA should include valid scientific evidence ``obtained from 
well-controlled clinical studies, with detailed data,'' in order to 
provide reasonable assurance of the safety and effectiveness of the 
device for its intended use (see 21 CFR 860.7(c)(2)).
    Applicants should submit any PMA in accordance with FDA's 
``Premarket Approval (PMA) Manual.'' This manual is available upon 
request from FDA, Center for Devices and Radiological Health, Division 
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., 
Rockville, MD 20850. This manual is also available on the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.

VI. PDP Requirements

    A PDP for any of these devices may be submitted in lieu of a PMA, 
and must

[[Page 65017]]

follow the procedures outlined in section 515(f) of the act. A PDP 
should provide: (1) A description of the device, (2) preclinical trial 
information (if any), (3) clinical trial information (if any), (4) a 
description of the manufacturing and processing of the devices, (5) the 
labeling of the device, and (6) all other relevant information about 
the device. In addition, the PDP must include progress reports and 
records of the trials conducted under the protocol on the safety and 
effectiveness of the device for which the completed PDP is sought.
    Applicants should submit any PDP in accordance with FDA's ``PDP 
Comprehensive Outline With Attachments.'' This outline is available 
upon request from FDA, Center for Devices and Radiological Health, 
Office of Device Evaluation (HFZ-400), 9200 Corporate Blvd., Rockville, 
MD 20850. The outline and other PDP information is also available on 
the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pdp.

VII. Request for Comments With Data

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

VIII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a 
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through 
(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity 
for interested persons to request a change in the classification of the 
device based on new information relevant to the classification. Any 
proceeding to reclassify the device will be under the authority of 
section 513(e) of the act.
    A request for a change in the classification of these devices is to 
be in the form of a reclassification petition containing the 
information required by Sec.  860.123 (21 CFR 860.123), including new 
information relevant to the classification of the device.
    The agency advises that, to ensure timely filing of any such 
petition, any request should be submitted to the Division of Dockets 
Management (see ADDRESSES) and not to the address provided in Sec.  
860.123(b)(1). If a timely request for a change in the classification 
of these devices is submitted, the agency will, by January 20, 2004, 
after consultation with the appropriate FDA advisory committee and by 
an order published in the Federal Register, either deny the request or 
give notice of its intent to initiate a change in the classification of 
the device in accordance with section 513(e) of the act and 21 CFR 
860.130 of the regulations.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
order and so is not subject to review under the Executive order.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. Because there have been no premarket 
submissions for these devices in the past 5 years, FDA has concluded 
that there is little or no interest in marketing these devices in the 
future. Therefore, the agency certifies that the proposed rule, if 
issued as a final rule, will not have a significant impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

XI. 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.

XII. Proposed Effect Date

    FDA is proposing that any final rule based on this proposal become 
effective 12 months after the date of its publication in the Federal 
Register or at a later date if stated in the final rule.

List of Subjects

21 CFR Parts 868, 870, and 882

    Medical devices.
    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 868, 870, and 882 be amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 868.1120 is amended by revising paragraph (c) to read as 
follows:


Sec.  868.1120  Indwelling blood oxyhemoglobin concentration analyzer.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before [date 90 days after date of 
publication of the final rule in the Federal Register], for any 
indwelling blood oxyhemoglobin concentration analyzer that was in 
commercial distribution before May 28, 1976, or that has, on or before 
[date 90 days after date of publication of the final rule in the 
Federal Register], been found to be substantially equivalent to an 
indwelling blood oxyhemoglobin concentration analyzer that was in 
commercial distribution before May 28, 1976. Any other indwelling blood 
oxyhemoglobin concentration analyzer shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

PART 870--CARDIOVASCULAR DEVICES

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

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    4. Section 870.4320 is amended by revising paragraph (c) to read as 
follows:

[[Page 65018]]

Sec.  870.4320  Cardiopulmonary bypass pulsatile flow generator.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before [date 90 days after date of 
publication of the final rule in the Federal Register], for any 
cardiopulmonary bypass pulsatile flow generator that was in commercial 
distribution before May 28, 1976, or that has, on or before [date 90 
days after date of publication of the final rule in the Federal 
Register], been found to be substantially equivalent to any 
cardiopulmonary bypass pulsatile flow generator that was in commercial 
distribution before May 28, 1976. Any other cardiopulmonary bypass 
pulsatile flow generator shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

PART 882--NEUROLOGICAL DEVICES

    5. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
    6. Section 882.1790 is amended by revising paragraph (c) to read as 
follows:


Sec.  882.1790  Ocular plethysmograph.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before [date 90 days after date of 
publication of the final rule in the Federal Register], for any ocular 
plethysmograph that was in commercial distribution before May 28, 1976, 
or that has, on or before [date 90 days after date of publication of 
the final rule in the Federal Register], been found to be substantially 
equivalent to any ocular plethysmograph that was in commercial 
distribution before May 28, 1976. Any other ocular plethysmograph shall 
have an approved PMA or declared completed PDP in effect before being 
placed in commercial distribution.

    Dated: November 6, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-28741 Filed 11-17-03; 8:45 am]

BILLING CODE 4160-01-S