[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Proposed Rules]
[Pages 16365-16370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7192]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA-2009-N-0458]
RIN 0910-AG29
Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulations on premarket approval of medical devices to include
requirements relating to the submission of information on pediatric
subpopulations that suffer from the disease or condition that a device
is intended to treat, diagnose, or cure. Elsewhere in this issue of the
Federal Register, we are publishing a companion direct final rule. This
[[Page 16366]]
proposed rule will provide a procedural framework to finalize the rule
in the event we receive significant adverse comment and withdraw the
direct final rule.
DATES: Submit electronic or written comments on the proposed rule by
June 15, 2010. Submit electronic or written comments on the information
collection requirements by June 1, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0458, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://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 number and regulatory information number (RIN) for this
rulemaking. All comments received may be posted without change to
http://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 http://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.
FOR FURTHER INFORMATION CONTACT: Robert Gatling, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796-
6560.
SUPPLEMENTARY INFORMATION:
I. Why Is This Companion Proposed Rule Being Issued?
This proposed rule is a companion to a direct final rule regarding
the submission of information on pediatric subpopulations that suffer
from a disease or condition that a device is intended to treat,
diagnose, or cure. The direct final rule is published in the final
rules section of this issue of the Federal Register. The direct final
rule and this companion proposed rule are substantively identical. This
companion proposed rule provides the procedural framework to finalize
the rule in the event that the direct final rule receives any
significant adverse comment and is withdrawn. We are publishing the
direct final rule because we believe the rule is noncontroversial, and
we do not anticipate receiving any significant adverse comments. If no
significant adverse comment is received in response to the direct final
rule, no further action will be taken relating to this proposed rule.
Instead, we will publish a notice within 30 days after the comment
period ends confirming when the direct final rule will go into effect.
If we receive any significant adverse comment regarding the direct
final rule we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using our usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 552a et seq.). The comment period for this companion proposed
rule runs concurrently with the direct final rule's comment period. Any
comments received under this companion proposed rule will be considered
as comments regarding the direct final rule and vice versa. We will not
provide additional opportunity for comment.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the APA (5 U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered a significant adverse comment, unless the comment states why
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to part of a rule
and that part can be severed from the remainder of the rule, we may
adopt as final those parts of the rule that are not the subject of a
significant adverse comment.
In the Federal Register of November 21, 1997 (62 FR 62466), you can
find additional information about FDA's direct final rulemaking
procedures in our guidance document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures.'' This guidance document is
available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
II. What Is the Background of This Proposed Rule?
On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA)\1\ (Public Law 110-85) amended the Federal Food,
Drug, and Cosmetic Act (the act) by adding, among other things, a new
section 515A of the act (21 U.S.C. 360e-1). Section 515A(a) of the act
requires persons who submit certain medical device applications to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This proposed rule amends FDA's
regulations to implement the requirements of section 515A(a) of the
act.
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\1\ Title III of FDAAA, which includes new section 515A, is also
known as the Pediatric Medical Device Safety and Improvement Act of
2007.
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Section 515A(c) of the act states that, for the purposes of that
section, the term ``pediatric subpopulation'' has the meaning given the
term in section 520(m)(6)(E)(ii) of the act (21 U.S.C.
360j(m)(6)(E)(ii)). Section 520(m)(6)(E)(ii) of the act defines the
term ``pediatric subpopulation'' to mean one of the following
populations:
Neonates;
Infants;
Children; or
Adolescents.
We have previously issued guidance recommending the age range for
each of the populations included in the term ``pediatric
subpopulation.'' See Premarket Assessment of Pediatric Medical Devices
(May 14, 2004); http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
The term ``pediatric patient'' is defined, for purposes of section
520(m)(6)(E)(i) of the act as patients who are 21 years of age or
younger at the time of the diagnosis or treatment. Because no other
definition of ``pediatric patient'' is included in the Pediatric
Medical Device Safety and Improvement Act of 2007, and because the
definition in section 520(m)(6)(E)(i) of the act is consistent with the
definition of pediatric subpopulations in section 520(m)(6)(E)(ii), FDA
has concluded
[[Page 16367]]
that the term ``pediatric patient'' in section 515A of the act refers
to patients who are 21 years of age or younger at the time of the
diagnosis or treatment.
The information submitted under section 515A(a) of the act will
help FDA track the following information that it is required to report
annually to Congress, in accordance with section 515A(a)(3) of the act:
The number of approved devices for which there is a
pediatric subpopulation that suffers from the disease or condition that
the device is intended to treat, diagnose, or cure;
The number of approved devices labeled for use in
pediatric patients;
The number of approved pediatric devices that were
exempted from a review fee under section 738(a)(2)(B)(v) of the act (21
U.S.C. 379j(a)(2)(B)(v)); and
The review time for each such device.
III. What Applications Are Subject to This Proposed Rule?
In accordance with the act, these requirements apply to the
following applications when submitted on or after the effective date of
this proposed rule:
Any request for a humanitarian device exemption (HDE)
submitted under section 520(m) of the act;
Any premarket approval application (PMA) or supplement to
a PMA submitted under section 515 of the act; and
Any product development protocol (PDP) submitted under
section 515 of the act.
If the applicant of a supplement to a PMA has previously submitted
information satisfying these requirements, the applicant may
incorporate that information by reference rather than resubmitting the
same information. However, if additional information has become readily
available to the applicant since the previous submission, the applicant
must submit that information as part of the supplement.
Many PMAs begin with the submission of one or more PMA modules; see
Premarket Approval Application Modular Review--Guidance for Industry
and FDA Staff, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm. Applicants
who choose to use the modular approach should submit the information
required by section 515A(a) of the act in the final PMA module (i.e.,
the module that includes final clinical data, proposed labeling, and
the summary of safety and effectiveness).
IV. What Does This Proposed Rule Do?
This proposed rule would implement new section 515A(a) of the act
by amending 21 CFR Part 814, Premarket Approval of Medical Devices, to
include requirements relating to the submission of information on
pediatric subpopulations that suffer from the disease or condition that
a device is intended to treat, diagnose, or cure.
A. What Information Must Be Provided?
This proposed rule requires each applicant who submits an HDE, PMA,
supplement to a PMA, or PDP to include, if ``readily available,'' a
description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients.
B. What Are the Consequences of Not Submitting ``Readily Available''
Information?
If you do not submit the information required by section 515A(a) of
the act, FDA may not approve your application until you provide the
required information. We intend to contact you during the normal course
of our review to inform you that your submission lacks the information
required by section 515A(a) of the act and by this proposed rule, and
to ask you to amend your application to provide the required
information. If your application has no other deficiencies and
otherwise meets applicable statutory and regulatory requirements for
approval, but still lacks information required by section 515A(a) of
the act, we intend to send you an ``approvable'' letter informing you
that we will approve your application after you provide the information
required by section 515A(a). If your application has other deficiencies
or does not meet all applicable statutory and regulatory requirements
for approval, we intend to send you a ``not approvable'' letter or a
``major deficiency'' letter describing what information or data you
need to provide before FDA can approve your application; the ``not
approvable'' or ``major deficiency'' letter may cite the absence of
515A(a) information in the section listing minor deficiencies. For
additional information concerning the interactive process we will use
during our review, see Guidance for Industry and FDA Staff: Interactive
Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA
Supplements, Original BLAs, and BLA Supplements, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htm. For additional information concerning
``approvable,'' ``not approvable,'' and ``major deficiency'' letters,
see FDA and Industry Actions on Premarket Approval Applications (PMAs):
Effect on FDA Review Clock and Goals, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089733.htm.
V. What Is the Legal Authority for This Proposed Rule?
This proposed rule, if finalized, would amend Sec. Sec. 814.1,
814.2, 814.20, 814.37, 814.39, 814.44, 814.100, 814.104, and 814.116.
FDA's legal authority to modify Sec. Sec. 814.1, 814.2, 814.20,
814.37, 814.39, 814.44, 814.100, 814.104, and 814.116 arises from the
same authority under which FDA initially issued these regulations, the
device and general administrative provisions of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 360e, 360e-1, 360j, and
371).
VI. What Is the Environmental Impact of This Proposed Rule?
FDA has determined under 21 CFR 25.30(h) and 25.34(a) 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.
VII. What Is the Economic Impact of This Proposed Rule?
We have examined the impacts of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is not a significant regulatory action as defined by the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this regulation only requires that some
submissions include a small amount of readily available information,
creating little additional burden, the agency certifies that the
proposed rule will not have a significant
[[Page 16368]]
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 $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.
We believe that the only costs to industry are those that we
account for in our Paperwork Reduction Act analysis, which immediately
follows this section. The proposed rule does not require additional
clinical research or other costly efforts, and simply requires the
applicant to briefly summarize readily available information that will
have been reviewed by the applicant during the course of its
development of the device and preparation of its application to FDA. We
have also limited the proposed rule to exclude supplements that do not
involve a new intended use; if a supplement does not involve a new
intended use, we do not expect the applicant will have new information
pertinent to the requirement of section 515A(a) of the act and this
rule, and the limitation avoids the needless submission of duplicate
information to FDA. We expect FDA's additional costs will be
inconsequential, as the information required here will be filed and
managed as an integral part of each submission, using existing filing,
storage, and data management systems and processes.
VIII. How Does the Paperwork Reduction Act of 1995 Apply to This
Proposed Rule?
This proposed rule contains information collection requirements
that 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
title, description, and respondent description of the information
collection provisions are shown below with an estimate of the annual
reporting burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information. FDA invites comments on: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection techniques, when
appropriate, and other forms of information technology.
Title: Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure.
Description: Section 515A(a) of FDAAA requires applicants who
submit certain medical device applications to include readily available
information providing a description of any pediatric subpopulations
that suffer from the disease or condition that the device is intended
to treat, diagnose, or cure, and the number of affected pediatric
patients. The information submitted will allow FDA to track the number
of approved devices for which there is a pediatric subpopulation that
suffers from the disease or condition that the device is intended to
treat, diagnose, or cure; the number of approved devices labeled for
use in pediatric patients; the number of approved pediatric devices
that were exempted from a review fee under section 738(a)(2)(B)(v) of
the act; and the review time for each such device.
Description of Respondents: These requirements apply to applicants
who submit the following applications when submitted on or after the
effective date of this rule:
Any request for an HDE submitted under section 520(m) of
the act;
Any PMA submitted under section 515 of the act;
Any PDP submitted under section 515 of the act; and
Any supplement to an HDE, PMA, or PDP that proposes a new
intended use, whether for an adult population or a pediatric
population.
Burden: FDA estimates the burden of this collection of information
as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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814.20(b)(3)(i) 25 1 25 4 100
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814.37(b)(2) 10 1 10 4 40
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814.39(h) 10 1 10 4 40
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814.104(b)(6) 5 1 5 4 20
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Totals 200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
All that is required is to access, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the act and this rule. FDA expects
to receive approximately 40 original PMA/PDP/HDE applications each
year, 5 of which FDA expects to be HDEs. This estimate is based on the
actual average of FDA's receipt of new PMA applications in FY 2007
through FY 2008. The agency estimates that 10 of those 40 original PMA
submissions will fail to provide the required pediatric use information
and their sponsors will therefore be required to submit PMA amendments.
The agency also expects to receive 10 supplements that describe a new
indication for use and will include the pediatric use information
required by 515A(a) of the act and this rule. We believe that because
the rule requires that the applicant organize and submit only
[[Page 16369]]
readily available information, no more than 4 hours will be required to
comply with section 515A(a) of the act and this rule. FDA estimates
that the total burden created by this rule is 200 hours.
We based this estimate on our experience with similar information
collection requirements and on consultations with the Interagency
Pediatric Devices Working Group which includes the Agency for
Healthcare Research and Quality, FDA, National Institutes of Health,
members of the Pediatric Advisory Committee, researchers, healthcare
practitioners, medical device trade associations, and medical device
manufacturers.
In compliance with the provisions of the Paperwork Reduction Act of
1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection provisions of this proposed rule to OMB for review. As
provided in 5 CFR 1320.5(c)(1), collections of information in a
proposed rule are subject to the procedures set forth in 5 CFR 1320.10.
Interested persons and organizations may submit comments on the
information collection requirements of this proposed rule (see DATES)
to the Division of Dockets Management (see ADDRESSES).
At the close of the 60-day comment period, FDA will review the
comments received, revise the information collection provisions as
necessary, and submit these provisions to OMB for review. FDA will
publish a notice in the Federal Register when the information
collection provisions are submitted to OMB, and an opportunity for
public comment to OMB will be provided at that time. Prior to the
effective date of the direct final rule, FDA will publish a notice in
the Federal Register of OMB's decision to approve, modify, or
disapprove the information collection provisions. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
IX. What Are the Federalism Impacts of This Proposed Rule?
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have 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, we have 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.
X. How Do You Submit Comments on This Rule?
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this proposed
rule. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
814 is proposed to be amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
1. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
2. In Sec. 814.1, revise paragraph (a) to read as follows:
Sec. 814.1 Scope.
(a) This section implements sections 515 and 515A of the act by
providing procedures for the premarket approval of medical devices
intended for human use.
* * * * *
3. Revise Sec. 814.2 to read as follows:
Sec. 814.2 Purpose.
The purpose of this part is to establish an efficient and thorough
device review process--
(a) To facilitate the approval of PMAs for devices that have been
shown to be safe and effective and that otherwise meet the statutory
criteria for approval;
(b) To ensure the disapproval of PMAs that have not been shown to
be safe and effective or that do not otherwise meet the statutory
criteria for approval; and
(c) To ensure PMAs include readily available information concerning
actual and potential pediatric uses of medical devices.
4. In Sec. 814.20, revise paragraph (b)(3)(i) to read as follows:
Sec. 814.20 Application.
* * * * *
(b) * * *
(3) * * *
(i) Indications for use. (A) A general description of the disease
or condition the device will diagnose, treat, prevent, cure, or
mitigate, including a description of the patient population for which
the device is intended.
(B) Information concerning uses in pediatric patients who are 21
years of age or younger: The application must include the following
information, if readily available:
(1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
(2) The number of affected pediatric patients.
* * * * *
5. In Sec. 814.37, revise the section heading and paragraph (b) to
read as follows:
Sec. 814.37 PMA amendments and resubmitted PMAs.
* * * * *
(b)(1) FDA may request the applicant to amend a PMA or PMA
supplement with any information regarding the device that is necessary
for FDA or the appropriate advisory committee to complete the review of
the PMA or PMA supplement.
(2) FDA may request the applicant to amend a PMA or PMA supplement
with information concerning pediatric uses as required under Sec.
814.20(b)(3)(i).
* * * * *
6. In Sec. 814.39, add paragraph (h) to read as follows:
Sec. 814.39 PMA supplements.
* * * * *
(h) The application must include the following information, if
readily available:
(1) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
(2) The number of affected pediatric patients who are 21 years of
age or younger.
(3) If information concerning the device that is the subject of the
supplement was previously submitted under Sec. 814.20(b)(3)(i), that
information may be incorporated by reference to the application or
submission that contains
[[Page 16370]]
the information. However, if additional information required under
Sec. 814.20(b)(3)(i) has become readily available to the applicant
since the previous submission, the applicant must submit that
information as part of the supplement.
7. In Sec. 814.44, redesignate paragraphs (e)(1)(ii) through
(e)(1)(iv) as paragraphs (e)(1)(iii) through (e)(1)(v), respectively,
and add new paragraph (e)(1)(ii) to read as follows:
Sec. 814.44 Procedures for review of a PMA.
* * * * *
(e) * * *
(1) * * *
(ii) The submission of additional information concerning potential
pediatric uses required by Sec. 814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *
8. Amend Sec. 814.100 as follows:
a. Redesignate paragraphs (b) through (e) as paragraphs (d) through
(g), respectively;
b. Redesignate paragraph (a) as paragraph (b), and remove the first
sentence of redesignated paragraph (b); and
c. Add new paragraphs (a) and (c) to read as follows:
Sec. 814.100 Purpose and scope.
(a) This subpart H implements sections 515A and 520(m) of the act.
* * * * *
(c) Section 515A of the act is intended to ensure the submission of
readily available information concerning actual and potential pediatric
uses of medical devices.
* * * * *
9. Amend Sec. 814.104 as follows:
a. Revise the last sentence of paragraph (b)(4)(ii);
b. Revise the last sentence of paragraph (b)(5); and
c. Add paragraph (b)(6) to read as follows:
Sec. 814.104 Original applications.
* * * * *
(b) * * *
(4) * * *
(ii) * * * The effectiveness of this device for this use has not
been demonstrated.
(5) * * * If the amount charged is $250 or less, the requirement
for a report by an independent certified public accountant or an
attestation by a responsible individual of the organization is waived;
and
(6) Readily available information concerning actual and potential
pediatric uses of the device, as required by Sec. 814.20(b)(3)(i).
* * * * *
10. In Sec. 814.116, redesignate paragraphs (c)(2) through (c)(4)
as paragraphs (c)(3) through (c)(5), respectively, and add new
paragraph (c)(2) to read as follows:
Sec. 814.116 Procedures for review of an HDE.
* * * * *
(c) * * *
(2) The submission of additional information concerning potential
pediatric uses required by Sec. 814.20(b)(3)(i) that is readily
available to the applicant;
* * * * *
Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7192 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S