Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode, 48058-48062 [2011-19959]
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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules
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instructions for submitting comments.
Dated: August 2, 2011.
Todd A. Stevenson,
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Commission.
[FR Doc. 2011–19912 Filed 8–5–11; 8:45 am]
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SUPPLEMENTARY INFORMATION:
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:
Proposed rule.
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 class III
preamendments device: Cardiovascular
permanent pacemaker electrode. The
Agency is also summarizing its
proposed findings regarding the degree
of risk of illness or injury designed to
be eliminated or reduced by requiring
this device to meet the statute’s
approval requirements and the benefits
to the public from the use of the device.
In addition, FDA is announcing the
opportunity for interested persons to
request that the Agency change the
classification of the cardiovascular
permanent pacemaker electrode based
on new information. This action
implements certain statutory
requirements.
SUMMARY:
Submit either electronic or
written comments by November 7, 2011.
Submit requests for a change in
classification by August 23, 2011. 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 XI of this
document for the proposed effective
date of any final rule that may publish
based on this proposal.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0505, by any of the following methods:
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DATES:
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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 (the SMDA) (Pub. L. 101–629), and
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), the Medical Devices
Technical Corrections Act (Pub. L. 108–
214), and the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), establish 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, reflecting the
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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 (21
U.S.C. 360e(b)(1)) 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) of the FD&C Act is not required
to have an approved investigational
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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 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).
If a proposed 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 later of the two dates,
commercial distribution of the device is
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required to cease since the device would
be deemed adulterated under section
501(f) of the FD&C Act.
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 the device
does not comply with IDE regulations,
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
or PDP 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 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
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
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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
the device.
II. Dates New Requirements Apply
In accordance with section 515(b) of
the FD&C 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
FD&C 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 § 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 from the
requirements of the IDE regulations for
preamendments class III devices in
§ 812.2(c)(1) and (c)(2) 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 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 under
§ 812.30. FDA, therefore, cautions that
IDE applications should be submitted to
FDA at least 30 days before the end of
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the 90-day period after the issuance of
the final rule to avoid interrupting
investigations.
III. Proposed Findings With Respect to
Risks and Benefits
As required by section 515(b) of the
FD&C 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 this device have an
approved PMA or a declared completed
PDP, and (2) the benefits to the public
from the use of the device.
These findings are based on the
reports and recommendations of the
advisory committee (panel) for the
classification of this device 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 this
device type can be found in the
following proposed and final rules and
notices published in the Federal
Register on these dates: (45 FR 7907 at
7971, February 5, 1980; 52 FR 17736,
May 11, 1987; and 60 FR 41986, August
14, 1995).
IV. Device Subject to This Proposal
Cardiovascular Permanent or
Temporary Pacemaker Electrode;
Permanent Pacemaker Electrode (21
CFR 870.3680(b)).
emcdonald on DSK2BSOYB1PROD with PROPOSALS
A. Identification
A permanent pacemaker electrode is a
device consisting of flexible insulated
electrical conductors with one end
connected to an implantable pacemaker
pulse generator and the other end
applied to the heart. The device is used
to transmit a pacing electrical stimulus
from the pulse generator to the heart
and/or to transmit the electrical signal
of the heart to the pulse generator.
B. Summary of Data
The Cardiovascular Devices
Classification Panel recommended that
this device be classified into class III as
permanent pacemaker electrodes are
permanent implants providing lifesupporting or life-sustaining therapy.
Over time, the devices that have been
designed and developed have evolved
and are widely variable from model to
model as well as from manufacturer to
manufacturer. These designs are
generally more complex and of smaller
sizes which may increase risk of failure
and introduce new failure modes.
Accordingly, this has limited the ability
to develop comprehensive performance
standards which would apply to all
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aspects of pacemaker lead design,
testing, and use. Adequate performance
standards have not yet been developed.
The potential safety and effectiveness
risks, unsuitability of general and
special controls, long-term use as
permanent implants of life-sustaining
therapy, and documented field failures
warrant classification of this device as
class III.
C. Risks to Health
• Material risks. The material
properties of pacemaker leads,
including mechanical, electrical,
biostability, biocompatibility, corrosion
and other characteristics can affect acute
and chronic performance.
• Design risks. Lead designs may
introduce features or geometries that
depart from traditional designs,
geometries, or sizes and which may
result in degradation of performance
and safety of use.
• Manufacturing risks. Manufacturing
variation, the introduction of more
complex and smaller designs, or quality
system failures may introduce device
defects that may not be identified with
bench testing or acute in vivo studies.
• Clinical-use risks.
Thromboembolism, perforation, tissue
reaction (exit block), dislodgement,
infection, air embolism, muscle/nerve
stimulation, stenosis, and erosion/
extrusion may occur as a result of the
clinical use and/or device malfunction.
V. PMA Requirements
A PMA for this device must include
the information required by section
515(c)(1) of the FD&C 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 must include valid scientific
evidence to demonstrate reasonable
assurance of the safety and effectiveness
of the device for its intended use (see
§ 860.7(c)(2) (21 CFR 860.7(c)(2)). Valid
scientific evidence is ‘‘evidence from
well-controlled investigations, partially
controlled studies, studies and objective
trials without matched controls, welldocumented case histories conducted by
qualified experts, and reports of
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significant human experience with a
marketed device, from which it can
fairly and responsibly be concluded by
qualified experts that there is reasonable
assurance of the safety and effectiveness
of a device under its conditions of use.
* * * Isolated case reports, random
experience, reports lacking sufficient
details to permit scientific evaluation,
and unsubstantiated opinions are not
regarded as valid scientific evidence to
show safety or effectiveness.’’
(§ 860.7(c)(2)).
VI. PDP Requirements
A PDP for this device may be
submitted instead of a PMA, and must
follow the procedures outlined in
section 515(f) of the FD&C Act. A PDP
must 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
device; (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.
VII. 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 FD&C 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 FD&C
Act.
A request for a change in the
classification of this device is to be in
the form of a reclassification petition
containing the information required by
§ 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 § 860.123(b)(1). If a timely
request for a change in the classification
of this device is submitted, the Agency
will, within 60 days after receipt of the
petition, and after consultation with the
appropriate FDA resources, publish an
order in the Federal Register that either
denies the request or gives notice of its
intent to initiate a change in the
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classification of the device in
accordance with section 513(e) of the
FD&C Act and § 860.139 (21 CFR
860.130) of the regulations.
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VIII. 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.
IX. Analysis of Impacts
FDA has examined the impacts of the
proposed 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 proposed 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 proposes
to certify that the final rule would 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 proposed rule to result in any oneyear expenditure that would meet or
exceed this amount.
A. Costs of the Proposed Rule
Under the proposed rule, FDA would
require producers in the cardiovascular
permanent pacemaker electrode
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industry to obtain PMA or establish a
PDP before marketing new products.
Similarly, producers of cardiovascular
permanent pacemaker electrodes that
are already on the market would need
to submit PMA applications 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
would be affected by this proposed rule.
We therefore estimate that the proposed
rule would generate between 18 and 23
PMA or PDP submissions. FDA has
estimated an upper bound on the cost of
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 would 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 would be the
difference between the cost of preparing
and submitting a premarket approval
application and the cost of preparing
and submitting a 510(k) application.
However, FDA has not received any
submissions for new devices of the type
subject to the proposed rule since
August 2004. We expect the recent
pattern of zero submissions to continue;
therefore, the proposed rule would not
generate submission costs on an ongoing
basis.
Some producers of devices that are
subject to the proposed rule could be
dissuaded from seeking approval by the
cost of submitting a PMA application or
by a low expectation that FDA would
grant approval for their products. In
these cases, producers would
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 PMA). Additionally, there
would be a welfare loss experienced by
consumers who would, in the absence
of the proposed rule, use the
cardiovascular permanent pacemaker
electrodes that would be withdrawn or
withheld from the market as a result of
the call for PMA or PDP. Due to the lack
of sufficient market data, we cannot
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48061
quantify these consumers’ welfare loss.
FDA requests comment on this issue
and on all methods and results of our
cost estimation.
In addition to the cost to industry of
preparing and submitting PMAs or
PDPs, the proposed rule would impose
incremental review costs on FDA.
Geiger (2005) (Ref. 1) 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. Updated for
inflation (using U.S. Department of
Commerce, 2011) (Ref. 2) to 2010
dollars, this average review cost
becomes $653,000 per PMA. Thus, the
proposed rule’s review-related costs are
expected to be between $11.8 million
(18 × $653,000) and $15.0 million (23 ×
$653,000). A portion of this total would
be paid by industry in the form of user
fees, with the remainder coming from
general revenues. FDA’s Data universal
numbering system database reveals that
the manufacturers affected by this
proposed rule have annual revenues
over $100 million, so they would 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 45632 at 45643),
so user fees would likely cover $4.3
million (= 18*$236,298) to $5.4 million
(= 23*$236,298) of FDA review costs,
with the remaining $7.5 to $9.6 million
coming from general revenues.
B. Benefits of the Proposed Rule
The proposed requirement for
premarket approval applications or
product development protocols for
cardiovascular permanent pacemaker
electrodes would produce social
benefits equal to the value of the
information generated by the safety and
effectiveness tests that producers would
be required to conduct as part of the
PMA or PDP process. Provided first to
FDA, this information would 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 proposed rule, but we are
unable to quantify the value of
information associated with each
submission. We request comment on
this issue.
X. Paperwork Reduction Act of 1995
This proposed rule refers to
previously 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
E:\FR\FM\08AUP1.SGM
08AUP1
48062
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Proposed Rules
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 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.
XI. Proposed Effective Date
FDA is proposing that any final rule
based on this proposal become effective
on the date of its publication in the
Federal Register or at a later date if
stated in the final rule.
XII. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
emcdonald on DSK2BSOYB1PROD with PROPOSALS
XIII. 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 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to the Web site 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, https://www.
fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeand
ModernizationActMDUFMA/umc109216.
2. U.S. Department of Commerce, Bureau of
Economic Analysis, National Income and
Product Accounts Table 1.1.9, https://
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, it is proposed that
21 CFR part 870 be amended as follows:
VerDate Mar<15>2010
18:42 Aug 05, 2011
Jkt 223001
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 870.3680 is amended by
revising paragraph (c) to read as follows:
§ 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 [A DATE
WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A
FUTURE FINAL RULE IN THE
FEDERAL REGISTER], for any
permanent pacemaker electrode that
was in commercial distribution before
May 28, 1976, or that has, on or before
[A DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A
FUTURE FINAL RULE IN THE
FEDERAL REGISTER], been found to be
substantially equivalent to any
permanent pacemaker electrode that
was in commercial distribution before
May 28, 1976. Any other permanent
pacemaker electrode shall have an
approved PMA or declared completed
PDP in effect before being placed in
commercial distribution.
Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–19959 Filed 8–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2011–N–0504]
Effective Date of Requirement for
Premarket Approval for Cranial
Electrotherapy Stimulator
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
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 Cranial
Electrotherapy Stimulator. The Agency
is also summarizing its proposed
SUMMARY:
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
findings regarding the degree of risk of
illness or injury designed to be
eliminated or reduced by requiring this
device to meet the statute’s approval
requirements and the benefits to the
public from the use of the device. In
addition, FDA is announcing the
opportunity for interested persons to
request that the Agency change the
classification of the cranial
electrotherapy stimulator based on new
information. This action implements
certain statutory requirements.
DATES: Submit either electronic or
written comments by November 7, 2011.
Submit requests for a change in
classification by August 23, 2011. 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: You may submit comments,
identified by Docket No. FDA–2011–N–
0504 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (For
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2011–N–0504 for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://www.
regulations.gov and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
E:\FR\FM\08AUP1.SGM
08AUP1
Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Proposed Rules]
[Pages 48058-48062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19959]
=======================================================================
-----------------------------------------------------------------------
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: Proposed rule.
-----------------------------------------------------------------------
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
class III preamendments device: Cardiovascular permanent pacemaker
electrode. The Agency is also summarizing its proposed findings
regarding the degree of risk of illness or injury designed to be
eliminated or reduced by requiring this device to meet the statute's
approval requirements and the benefits to the public from the use of
the device. In addition, FDA is announcing the opportunity for
interested persons to request that the Agency change the classification
of the cardiovascular permanent pacemaker electrode based on new
information. This action implements certain statutory requirements.
DATES: Submit either electronic or written comments by November 7,
2011. Submit requests for a change in classification by August 23,
2011. 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 XI of this document for the proposed effective date
of any final rule that may publish based on this proposal.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0505, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0505 for this rulemaking. All comments
received may be posted without change to https://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Elias Mallis, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-
796-6216.
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 (the SMDA) (Pub. L. 101-
629), and 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), the Medical Devices
Technical Corrections Act (Pub. L. 108-214), and the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), establish 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, reflecting 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 (21
U.S.C. 360e(b)(1)) 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) of the FD&C Act is not required to have an approved
investigational
[[Page 48059]]
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 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).
If a proposed 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 later of the
two dates, commercial distribution of the device is required to cease
since the device would be deemed adulterated under section 501(f) of
the FD&C Act.
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 the device does not comply
with IDE regulations, 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 or PDP 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 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 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. Moreover, in this
proposal, interested persons are being offered the opportunity to
request reclassification of the device.
II. Dates New Requirements Apply
In accordance with section 515(b) of the FD&C 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 FD&C
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), 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 from the requirements of the IDE regulations
for preamendments class III devices in Sec. 812.2(c)(1) and (c)(2)
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
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 under Sec. 812.30. FDA,
therefore, cautions that IDE applications should be submitted to FDA at
least 30 days before the end of
[[Page 48060]]
the 90-day period after the issuance of the final rule to avoid
interrupting investigations.
III. Proposed Findings With Respect to Risks and Benefits
As required by section 515(b) of the FD&C 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 this
device have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the device.
These findings are based on the reports and recommendations of the
advisory committee (panel) for the classification of this device 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 this device type can be found in the
following proposed and final rules and notices published in the Federal
Register on these dates: (45 FR 7907 at 7971, February 5, 1980; 52 FR
17736, May 11, 1987; and 60 FR 41986, August 14, 1995).
IV. Device Subject to This Proposal
Cardiovascular Permanent or Temporary Pacemaker Electrode;
Permanent Pacemaker Electrode (21 CFR 870.3680(b)).
A. Identification
A permanent pacemaker electrode is a device consisting of flexible
insulated electrical conductors with one end connected to an
implantable pacemaker pulse generator and the other end applied to the
heart. The device is used to transmit a pacing electrical stimulus from
the pulse generator to the heart and/or to transmit the electrical
signal of the heart to the pulse generator.
B. Summary of Data
The Cardiovascular Devices Classification Panel recommended that
this device be classified into class III as permanent pacemaker
electrodes are permanent implants providing life-supporting or life-
sustaining therapy. Over time, the devices that have been designed and
developed have evolved and are widely variable from model to model as
well as from manufacturer to manufacturer. These designs are generally
more complex and of smaller sizes which may increase risk of failure
and introduce new failure modes. Accordingly, this has limited the
ability to develop comprehensive performance standards which would
apply to all aspects of pacemaker lead design, testing, and use.
Adequate performance standards have not yet been developed. The
potential safety and effectiveness risks, unsuitability of general and
special controls, long-term use as permanent implants of life-
sustaining therapy, and documented field failures warrant
classification of this device as class III.
C. Risks to Health
Material risks. The material properties of
pacemaker leads, including mechanical, electrical, biostability,
biocompatibility, corrosion and other characteristics can affect acute
and chronic performance.
Design risks. Lead designs may introduce
features or geometries that depart from traditional designs,
geometries, or sizes and which may result in degradation of performance
and safety of use.
Manufacturing risks. Manufacturing variation,
the introduction of more complex and smaller designs, or quality system
failures may introduce device defects that may not be identified with
bench testing or acute in vivo studies.
Clinical-use risks. Thromboembolism,
perforation, tissue reaction (exit block), dislodgement, infection, air
embolism, muscle/nerve stimulation, stenosis, and erosion/extrusion may
occur as a result of the clinical use and/or device malfunction.
V. PMA Requirements
A PMA for this device must include the information required by
section 515(c)(1) of the FD&C 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 must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec. 860.7(c)(2) (21 CFR 860.7(c)(2)). Valid
scientific evidence is ``evidence from well-controlled investigations,
partially controlled studies, studies and objective trials without
matched controls, well-documented case histories conducted by qualified
experts, and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use. * * * Isolated
case reports, random experience, reports lacking sufficient details to
permit scientific evaluation, and unsubstantiated opinions are not
regarded as valid scientific evidence to show safety or
effectiveness.'' (Sec. 860.7(c)(2)).
VI. PDP Requirements
A PDP for this device may be submitted instead of a PMA, and must
follow the procedures outlined in section 515(f) of the FD&C Act. A PDP
must 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 device; (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.
VII. 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 FD&C 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 FD&C Act.
A request for a change in the classification of this device 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 this device is submitted, the Agency will, within 60 days after
receipt of the petition, and after consultation with the appropriate
FDA resources, publish an order in the Federal Register that either
denies the request or gives notice of its intent to initiate a change
in the
[[Page 48061]]
classification of the device in accordance with section 513(e) of the
FD&C Act and Sec. 860.139 (21 CFR 860.130) of the regulations.
VIII. 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.
IX. Analysis of Impacts
FDA has examined the impacts of the proposed 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 proposed 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 proposes to certify that the
final rule would 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
proposed rule to result in any one-year expenditure that would meet or
exceed this amount.
A. Costs of the Proposed Rule
Under the proposed rule, FDA would require producers in the
cardiovascular permanent pacemaker electrode industry to obtain PMA or
establish a PDP before marketing new products. Similarly, producers of
cardiovascular permanent pacemaker electrodes that are already on the
market would need to submit PMA applications 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 would be affected by this proposed rule. We therefore
estimate that the proposed rule would generate between 18 and 23 PMA or
PDP submissions. FDA has estimated an upper bound on the cost of 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 would 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 would be
the difference between the cost of preparing and submitting a premarket
approval application and the cost of preparing and submitting a 510(k)
application. However, FDA has not received any submissions for new
devices of the type subject to the proposed rule since August 2004. We
expect the recent pattern of zero submissions to continue; therefore,
the proposed rule would not generate submission costs on an ongoing
basis.
Some producers of devices that are subject to the proposed rule
could be dissuaded from seeking approval by the cost of submitting a
PMA application or by a low expectation that FDA would grant approval
for their products. In these cases, producers would 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 PMA).
Additionally, there would be a welfare loss experienced by consumers
who would, in the absence of the proposed rule, use the cardiovascular
permanent pacemaker electrodes that would be withdrawn or withheld from
the market as a result of the call for PMA or PDP. Due to the lack of
sufficient market data, we cannot quantify these consumers' welfare
loss. FDA requests comment on this issue and on all methods and results
of our cost estimation.
In addition to the cost to industry of preparing and submitting
PMAs or PDPs, the proposed rule would impose incremental review costs
on FDA. Geiger (2005) (Ref. 1) 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. Updated for inflation (using
U.S. Department of Commerce, 2011) (Ref. 2) to 2010 dollars, this
average review cost becomes $653,000 per PMA. Thus, the proposed rule's
review-related costs are expected to be between $11.8 million (18 x
$653,000) and $15.0 million (23 x $653,000). A portion of this total
would be paid by industry in the form of user fees, with the remainder
coming from general revenues. FDA's Data universal numbering system
database reveals that the manufacturers affected by this proposed rule
have annual revenues over $100 million, so they would 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 45632 at
45643), so user fees would likely cover $4.3 million (= 18*$236,298) to
$5.4 million (= 23*$236,298) of FDA review costs, with the remaining
$7.5 to $9.6 million coming from general revenues.
B. Benefits of the Proposed Rule
The proposed requirement for premarket approval applications or
product development protocols for cardiovascular permanent pacemaker
electrodes would produce social benefits equal to the value of the
information generated by the safety and effectiveness tests that
producers would be required to conduct as part of the PMA or PDP
process. Provided first to FDA, this information would 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
proposed rule, but we are unable to quantify the value of information
associated with each submission. We request comment on this issue.
X. Paperwork Reduction Act of 1995
This proposed rule refers to previously 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
[[Page 48062]]
(44 U.S.C. 3501-3520). The collections of information in 21 CFR 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.
XI. Proposed Effective Date
FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.
XII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
XIII. 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 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site 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, https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/umc109216.
2. U.S. Department of Commerce, Bureau of Economic Analysis,
National Income and Product Accounts Table 1.1.9, https://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, it is
proposed that 21 CFR part 870 be amended as follows:
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 870.3680 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 [A DATE WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER],
for any permanent pacemaker electrode that was in commercial
distribution before May 28, 1976, or that has, on or before [A DATE
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE
IN THE FEDERAL REGISTER], been found to be substantially equivalent to
any permanent pacemaker electrode that was in commercial distribution
before May 28, 1976. Any other permanent pacemaker electrode shall have
an approved PMA or declared completed PDP in effect before being placed
in commercial distribution.
Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19959 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P