[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Rules and Regulations]
[Pages 50663-50667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870 and 884

[Docket No. FDA-2010-N-0412]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
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: Ventricular bypass 
(assist) device; pacemaker repair or replacement material; and female 
condom. The Agency has summarized its 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. This action 
implements certain statutory requirements.

DATES: This rule is effective August 23, 2011.

[[Page 50664]]


FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993-0002, 301-796-6283.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), 
the Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 
2002 (Pub. L. 107-250), and the Food and Drug Administration Amendments 
Act of 2007 (Pub. L. 110-85), among other amendments, established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the FD&C 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 FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(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 
automatically classified by section 513(f) of the FD&C 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 FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III may 
be marketed by means of premarket notification procedures (510(k) 
process) without submission of a PMA until FDA issues a final 
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) 
requiring premarket approval. Section 515(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 FD&C Act, 
whichever is later. Also, a preamendments device subject to the 
rulemaking procedure under section 515(b) is not required to have an 
approved investigational device exemption (IDE) (see part 812 (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 FD&C Act provides that 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 FD&C 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 FD&C Act. Section 
515(b)(3) of the FD&C 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 
FD&C Act, unless the reason for termination is that the device is a 
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    When a rule to require premarket approval for a preamendments 
device is finalized, section 501(f)(2)(B) of the FD&C 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 of the device 
under section 513 of the FD&C Act, whichever is later. If a PMA or 
notice of completion of a PDP is not filed by the latter of the two 
dates, commercial distribution of the device must cease since the 
device would be deemed adulterated under section 501(f).
    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 latter 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 FD&C Act, and subject to seizure and condemnation 
under section 304 of the FD&C 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 FD&C Act (21 U.S.C. 332), and 
the individuals responsible for such shipment will be subject to 
prosecution under section 303 of the FD&C 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 device 
that is the subject of this regulation.
    The FD&C Act does not permit an extension of the 90-day period 
after issuance of a final rule within which an application or 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 of

[[Page 50665]]

premarket approval'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the FD&C Act requiring FDA to 
review the classification of preamendments class III devices for which 
no final rule requiring the submission of PMAs has been issued, 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 FD&C Act on specific devices, in the interest of public 
health, independent of the procedures of section 515(i). Proceeding 
directly to rulemaking under section 515(b) of the FD&C Act is 
consistent with Congress' objective in enacting section 515(i), i.e., 
that preamendments class III devices for which PMAs have not been 
previously required either be reclassified to class I or class II or be 
subject to the requirements of premarket approval.
    In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 
1994, notice), FDA issued a notice of availability of a preamendments 
class III devices strategy document. The strategy document set forth 
FDA's plans for implementing the provisions of section 515(i) of the 
FD&C Act for preamendments class III devices for which FDA had not yet 
required premarket approval. FDA divided this universe of devices into 
three groups as referenced in the May 6, 1994, notice.
    In the Federal Register of August 25, 2010 (75 FR 52294) (the 
August 25, 2010, proposed rule), FDA published a proposed rule to 
require the filing under section 515(b) of the FD&C Act of a PMA or 
notice of completion of a PDP for four premendments class III devices: 
Ventricular (bypass) assist device; pacemaker repair or replacement 
material; female condom; and transilluminator for breast evaluation. In 
accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in 
the preamble of the proposal the Agency's tentative findings with 
respect to the degree of risk of illness or injury designed to be 
eliminated or reduced by requiring the device to meet the premarket 
approval requirements of the FD&C Act, and the benefits to the public 
from use of the device. The August 25, 2010, proposed rule also 
provided an opportunity for interested persons to submit comments on 
the proposed rule and the Agency's findings. Under section 515(b)(2)(B) 
of the FD&C Act, FDA provided an opportunity for interested persons to 
request a change in the classification of the device based on new 
information relevant to its classification. Any petition requesting a 
change in classification of the devices was required to be submitted by 
September 9, 2010. The comment period closed November 23, 2010.
    FDA received no comments on the proposed rule. FDA received one 
petition requesting a change in the classification of the 
transilluminator for breast evaluation. FDA has yet to resolve the 
request; therefore, the transilluminator for breast evaluation is not 
subject to this final rule.

II. Findings With Respect to Risks and Benefits

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its 
findings as published in the August 25, 2010, proposed rule with the 
exception of the findings related to the transilluminator for breast 
evaluation. As required by section 515(b) of the FD&C Act, FDA 
published its 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 information submitted in response to the 515(i) Order, (74 
FR 16214, April 9, 2009), and any additional information that FDA has 
encountered. Additional information regarding the risks as well as 
classification associated with these device types can be found in the 
following proposed and final rules published in the Federal Register on 
these dates: Cardiovascular Devices--part 870 (21 CFR part 870) (44 FR 
13284, March 9, 1979 and 45 FR 7904, February 5, 1980, 52 FR 17732 at 
17736, May 11, 1987); and Obstetrical and Gynecological Devices--part 
884 (21 CFR part 884) (64 FR 31164, June 10, 1999, and 65 FR 31454, May 
18, 2000).

III. The Final Rule

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its 
findings as published in the preamble to the proposed rule with the 
exception of the findings related to the transilluminator for breast 
evaluation. FDA is issuing this final rule to require premarket 
approval of these generic types of devices for class III preamendments 
devices by revising parts 870 and 884.
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before 90 days after the date of publication 
of the final rule in the Federal Register, for any of these class III 
preamendments devices that were in commercial distribution before May 
28, 1976, or that has been found by FDA to be substantially equivalent 
to such a device on or before 90 days after the date of publication of 
the final rule in the Federal Register. An approved PMA or a declared 
completed PDP is required to be in effect for any such devices on or 
before 180 days after FDA files the application. Any other class III 
preamendments device subject to this rule that was not in commercial 
distribution before May 28, 1976, is required to have an approved PMA 
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of these class 
III preamendments devices is not filed on or before the 90th day past 
the effective date of this regulation, that device will be deemed 
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial 
distribution of the device will be required to cease immediately. The 
device may, however, be distributed for investigational use, if the 
requirements of the IDE regulations (part 812) are met.

IV. 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 final rule is not a significant 
regulatory action under Executive Order 12866.
    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 and all of the affected devices have 
fallen into disuse, FDA has

[[Page 50666]]

concluded that there is little or no interest in marketing these 
devices in the future. Therefore, the Agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    FDA has concluded that this final rule will not have a significant 
impact. We base this determination on an analysis of registration and 
listing and other data for the affected devices. Two of the devices 
affected by this final rule, the female condom and ventricular bypass 
device, have never appeared in FDA's electronic registration and 
listing database. These devices were identified as preamendment 
devices, but since their classification, the Agency has no record of 
them ever being marketed. In addition, these devices represent older 
technologies that have since been replaced by newer technologies 
currently being marketed under a PMA.
    The final affected device, pacemaker repair and replacement 
material, is a material that can be used in multiple devices that was 
last listed in 2001, and the Agency is aware of no evidence that the 
device has been marketed since 1991. In addition, on the increasingly 
rare occasions when a pacemaker is repaired today, the repair is done 
with materials specific to the approved device. This information is 
summarized in table 1 of this document as follows.

                                           Table 1--Summary of Electronic Registration and Listing Information
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                                                                                                                                 Replaced by  approved
            Device name                  Product code           510(k) or PMA?          Last listed          Last marketed            technology?
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Female Condom.....................  OBY...................  No...................  Never Listed........  1930s...............  Yes.
Ventricular Bypass Device.........  OKR...................  No...................  Never Listed........  No Record...........  Yes.
Pacemaker Repair and Replacement..  KFJ...................  No...................  2001................  1991................  Yes.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Based on our review of electronic product registration and listing 
and other data, FDA concludes that there is currently little or no 
interest in marketing the affected devices and that the final rule will 
not have a significant economic impact.

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 Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 812 have been approved under OMB 
control number 0910-0078; the collections of information in 21 CFR part 
807, subpart E, have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 814, subpart B, have been 
approved under OMB control number 0910-0231; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Parts 870 and 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
870 and 884 are amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
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.


0
2. Section 870.3545 is amended by revising paragraph (c) to read as 
follows:


Sec.  870.3545  Ventricular bypass (assist) device.

* * * * *
    (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 November 21, 2011, for any ventricular 
bypass (assist) device that was in commercial distribution before May 
28, 1976, or that has, on or before November 21, 2011, been found to be 
substantially equivalent to any ventricular bypass (assist) device that 
was in commercial distribution before May 28, 1976. Any other 
ventricular bypass (assist) device shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.


0
3. Section 870.3710 is amended by revising paragraph (c) to read as 
follows:


Sec.  870.3710  Pacemaker repair or replacement material.

* * * * *
    (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 November 21, 2011, for any pacemaker 
repair or replacement material device that was in commercial 
distribution before May 28, 1976, or that has, on or before November 
21, 2011, been found to be substantially equivalent to any pacemaker 
repair or replacement material device that was in commercial 
distribution before May 28, 1976. Any other pacemaker repair or 
replacement material device shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

[[Page 50667]]

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
4. The authority citation for 21 CFR part 884 continues to read as 
follows:

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

0
5. Section 884.5330 is amended by revising paragraph (c) to read as 
follows:


Sec.  884.5330  Female condom.

* * * * *
    (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 November 21, 2011, for any female 
condom that was in commercial distribution before May 28, 1976, or that 
has, on or before November 21, 2011, been found to be substantially 
equivalent to any female condom that was in commercial distribution 
before May 28, 1976. Any other female condom shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

    Dated: August 10, 2011.
Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-20664 Filed 8-15-11; 8:45 am]
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