
[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Rules and Regulations]
[Pages 39924-39927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16486]



[[Page 39924]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0505]


Effective Date of Requirement for Premarket Approval for 
Cardiovascular Permanent Pacemaker Electrode

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 
cardiovascular permanent pacemaker electrode. The Agency has summarized 
its findings regarding the degree of risk of illness or injury designed 
to be eliminated or reduced by requiring the device to meet the 
statute's approval requirements and the benefits to the public from the 
use of the device. This action implements certain statutory 
requirements.

DATES: This rule is effective October 4, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (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) of the FD&C Act 
establishes 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 because 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

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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 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.
    In the Federal Register of August 8, 2011 (76 FR 48058) (the August 
8, 2011, 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 the cardiovascular permanent pacemaker 
electrode. In accordance with section 515(b)(2)(A) of the FD&C Act, FDA 
included in the preamble of the proposed rule 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 8, 2011, 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 
devices based on new information relevant to its classification. Any 
petition requesting a change in classification for the cardiovascular 
permanent pacemaker electrode was required to be submitted by August 
23, 2011. The comment period for the cardiovascular permanent pacemaker 
electrode closed November 7, 2011.
    FDA received no comments on the proposed rule. FDA received no 
petitions requesting a change in the classification of the devices.

II. Findings With Respect to Risks and Benefits

    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 this device 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 (April 
9, 2009 (74 FR 16214)), and any additional information that FDA has 
encountered. Additional information regarding the risks as well as 
classification associated with the cardiovascular permanent pacemaker 
electrode can be found in the following proposed and final rules 
published in the Federal Register on these dates: March 9, 1979 (44 FR 
13379); February 5, 1980 (45 FR 7943); and May 11, 1987 (52 FR 17732 at 
17736).

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. FDA is 
issuing this final rule to require premarket approval of these generic 
types of devices for class III preamendments devices by revising part 
870.
    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 this class III 
preamendments device 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 this class 
III preamendments device 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 must 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

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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 as defined by 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 none of the manufacturers of affected 
products are small businesses, the Agency certifies that the 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 $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any one-year expenditure that would meet or 
exceed this amount.

A. Costs of the Rule

    Under the final rule, FDA will require producers in the 
cardiovascular permanent pacemaker electrode industry to obtain an 
approved PMA or establish a PDP before marketing new products. 
Similarly, producers of cardiovascular permanent pacemaker electrodes 
that are already on the market will need to submit PMAs or establish 
PDPs in order to continue commercial distribution of these products. 
Based on an analysis of registration and listing data, manufacturer Web 
sites, and responses to previous Federal Register requests for comment, 
FDA estimates that 5 to 10 manufacturers are marketing approximately 18 
to 23 devices that will be affected by this final rule. We therefore 
estimate that the final rule will generate between 18 and 23 PMA or PDP 
submissions. FDA has estimated an upper bound on the cost of a PMA at 
approximately $1,000,000 (see, for example, 73 FR 7501, February 8, 
2008), and we assume that the cost of a PDP is roughly equal to that of 
a PMA; this yields a rule-induced upfront cost of between $18 and $23 
million. We lack data with which to estimate how the burden of this 
cost will be distributed among device manufacturers, patients and 
insurance providers.
    For a new product (i.e., a cardiovascular permanent pacemaker 
electrode not currently on the market), the rule-induced cost will be 
the difference between the cost of preparing and submitting a PMA and 
the cost of preparing and submitting a 510(k) application. However, 
between August of 2004 and the present, FDA has not received any 
submissions for new devices of the type subject to the final rule. We 
expect the recent pattern of zero new product introduction to continue; 
therefore, the final rule will not generate submission costs on an 
ongoing basis.
    Some producers of devices that are subject to the final rule could 
be dissuaded from seeking approval by the cost of submitting a PMA or 
by a low expectation that FDA will grant approval for their products. 
In these cases, producers will experience a rule-induced cost equal to 
the foregone expected profit on the withdrawn or withheld 
cardiovascular permanent pacemaker electrodes, which is necessarily 
less than the cost of PMA submission (otherwise, the producers in 
question would not be dissuaded from seeking approval of a PMA). 
Additionally, there will be a welfare loss experienced by consumers who 
would, in the absence of the final rule, use the cardiovascular 
permanent pacemaker electrodes that will be withdrawn or withheld from 
the market as a result of the call for a PMA or a PDP. Lacking 
sufficient market data, we cannot quantify these consumers' welfare 
loss.
    In addition to the cost to industry of preparing and submitting 
PMAs or PDPs, the final rule will impose incremental review costs on 
FDA. Geiger (2005) estimated that, for devices reviewed by FDA's Center 
for Devices and Radiological Health in 2003 and 2004, review costs 
averaged $563,000 per PMA (Ref. 1). Updated for inflation (using U.S. 
Department of Commerce, 2011) to 2010 dollars, this average review cost 
becomes $653,000 per PMA. Thus, the final rule's review-related costs 
are expected to be between $11.8 million (= 18 x $653,000) (Ref. 2) and 
$15.0 million (= 23 x $653,000). A portion of this total will be paid 
by industry in the form of user fees, with the remainder borne by 
general taxpayers. FDA's DUNS database reveals that the manufacturers 
affected by this final rule have annual revenues over $100 million, so 
they will not be eligible for small business user fees. The standard 
user fee is currently set at $236,298 for a premarket application (PMA 
or PDP) (75 FR 45643), so user fees will likely cover $4.3 million (= 
18 x $236,298) to $5.4 million (= 23 x $236,298) of FDA review costs, 
with the remaining $7.5 to $9.6 million borne by general taxpayers.

B. Benefits of the Rule

    The final requirement for PMAs or PDPs for cardiovascular permanent 
pacemaker electrodes will produce social benefits equal to the value of 
the information generated by the safety and effectiveness tests that 
producers will be required to conduct as part of the PMA or PDP 
process. Provided first to FDA, this information will eventually assist 
physicians, patients and insurance providers in making more informed 
decisions about these devices. FDA expects there to be approximately 18 
to 23 PMA or PDP submissions as a result of the final rule, but we are 
unable to quantify the value of information associated with each 
submission.

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; and the collections of information under 21 
CFR part 801 have been approved under OMB control number 0910-0485.
    The effect of this rule, is to shift certain devices from the 
510(k) premarket notification process to the PMA process. To account 
for this change, FDA intends to transfer some of the burden from OMB 
Control Number 0910-0120, which is the control number for the 510(k) 
premarket notification process, to OMB Control Number 0910-0231, which 
is the control number for

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the PMA process. As noted in this document, FDA estimates that it will 
receive 21 new PMAs as a result of this rule. Based on FDA's most 
recent estimates, this will result in a 21,789 hour burden increase. 
FDA also estimates that there will be 21 fewer 510(k) submissions as a 
result of this rule. Based on FDA's most recent estimates, this will 
result in a 2,860 hour burden decrease. Therefore, on net, FDA expects 
a burden hour increase of 18,930 due to this regulatory change.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20857, and may be seen by 
interested persons between 9 a.m. and 4 p.m. Monday through Friday. FDA 
has verified Web site addresses, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.

1. Geiger, Dale R, ``FY 2003 and 2004 Unit Costs for the Process of 
Medical Device Review.'' September 2005, http:[sol][sol]www.fda.gov/
downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109216.
2. U.S. Department of Commerce, Bureau of Economic Analysis. 
National Income and Product Accounts Table 1.1.9, 
http:[sol][sol]www.bea.gov/national/nipaweb/SelectTable.asp, 
accessed March 25, 2011.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is 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 870.3680 is amended by revising paragraph (c) to read as 
follows:


Sec.  870.3680  Cardiovascular permanent or temporary pacemaker 
electrode.

* * * * *
    (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 October 4, 2012, for any permanent 
pacemaker electrode device that was in commercial distribution before 
May 28, 1976, or that has, on or before October 4, 2012, been found to 
be substantially equivalent to any permanent pacemaker electrode 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.

    Dated: June 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16486 Filed 7-5-12; 8:45 am]
BILLING CODE 4160-01-P


