
[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Pages 11612-11617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03647]


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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: Supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) published a proposed 
rule in the Federal Register of April 1, 2010, along with a companion 
direct final rule. The proposed rule proposed 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. The Agency received significant adverse 
comment and withdrew the direct final rule. The Agency is issuing this 
supplemental notice of proposed rulemaking re-proposing the amendments 
reflecting comments received.

DATES: Submit either electronic or written comments on the proposed 
rule by April 22, 2013. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by March 21, 2013, 
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0458 and/or RIN number 0910-AG29, by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 must be submitted to the Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB) (see the ``Paperwork Reduction Act of 1995'' section of this 
document).

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:
     Mail/Hand delivery/Courier (for paper 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-2009-N-0458 and Regulatory Information Number (RIN) 
0910-AG29 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: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Avenue, Bldg. 66, Rm. 1651, Silver Spring, MD 20993, 301-796-6563.

SUPPLEMENTARY INFORMATION:

[[Page 11613]]

I. What is the background of this proposed rule?

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) \1\ 
(Pub. L. 110-85) amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) by among other things, adding section 515A (21 U.S.C. 360e-1) 
of the FD&C Act. Section 515A(a) of the FD&C Act requires persons who 
submit certain medical device applications 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. The 
information submitted under section 515A(a) of the FD&C Act will be 
essential to completing the annual report that FDA is required to 
submit to Congress under section 515A(a)(3), including:
---------------------------------------------------------------------------

    \1\ Title III of FDAAA, which includes new section 515A, is also 
known as the Pediatric Medical Device Safety and Improvement Act of 
2007.
---------------------------------------------------------------------------

     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; and
     The review time for each such device application.
    On April 1, 2010, FDA had published a proposed rule, along with a 
companion direct final rule (75 FR 16347), with a 75-day comment period 
to request input from interested parties (75 FR 16365) as a step 
towards implementing section 515A(a) of the FD&C Act. A few months 
later, FDA withdrew the direct final rule because we received 
significant adverse comment (75 FR 41986, July 20, 2010). One of these 
comments stated that by revising Sec.  814.2 as proposed, FDA would 
exceed its statutory authority by changing the purpose of the 
regulation of medical devices. Furthermore, the comment stated that 
since FDA already has the framework to evaluate whether a PMA 
application includes all required content, this proposed amendment is 
unnecessary. Although FDA disagrees that it does not have the authority 
to enact such an amendment, the Agency agrees the amendment is 
unnecessary because the objective of ensuring that PMAs include readily 
available information concerning pediatric medical devices is subsumed 
in proposed Sec.  814.20(b)(13). Per 21 CFR 814.42(e)(2), FDA may 
refuse to file any PMA application that does not contain the elements 
required by 21 CFR 814.20. Consequently, FDA has concluded that an 
amendment to 21 CFR 814.2 is not needed in this proposed rule.
    Another comment challenged FDA's request for information on 
potential pediatric uses when implementing section 515A(a)(2) of the 
FD&C Act. The comment stated it is inappropriate to use the term 
``potential'' in proposed codified Sec. Sec.  814.44, 814.100, 814.104, 
and 814.116 because the statute does not require sponsors to speculate 
as to possible pediatric uses and possible subpopulations. FDA agrees 
with the comment and has revised the regulation by removing any mention 
of potential pediatric uses. The proposed regulation now mirrors the 
statute more closely and FDA believes this modification will facilitate 
compliance.
    Due to the changes made since the April 1, 2010, proposed rule and 
in particular, the scope of applications to which this requirement is 
to apply (see section II), we are taking this action to allow for 
public comment on the re-drafted proposed rule. In addition to 
providing FDA's revised proposal for implementing section 515A(a) of 
the FD&C Act, this document serves to supplement the proposed rule that 
issued with the companion direct final rule (75 FR 16365, April 1, 
2010).

II. How are pediatric patients and pediatric subpopulations defined?

    Section 515A(c) of the FD&C 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 FD&C Act (21 U.S.C. 
360j). Section 520(m)(6)(E)(ii) of the FD&C Act defines the term 
``pediatric subpopulation'' to mean one of the following populations:
     Neonates;
     Infants;
     Children; and
     Adolescents.
    Section 515A additionally requires that the descriptions of 
pediatric subpopulations include the number of affected ``pediatric 
patients.'' Section 515A does not define the term ``pediatric 
patients.'' The term ``pediatric patients,'' however, is defined for 
purposes of section 520(m)(6)(E)(i) of the FD&C Act (relating to 
humanitarian device exemptions for pediatric patients) as patients who 
are 21 years of age or younger at the time of the diagnosis or 
treatment. The definition for ``pediatric patients'' in section 
520(m)(6)(E)(i) of the FD&C Act is consistent with the definition of 
``pediatric subpopulations'' in section 520(m)(6)(E)(ii).
    These definitions of pediatric subpopulation and pediatric patient 
are reflected in FDA's previously issued 2004 guidance on pediatric 
medical devices which recommended the age range for each of the 
populations included in the term ``pediatric subpopulation.'' Those age 
ranges span from birth to 21 years of age (that is, from birth through 
the 21st year of life, up to but not including the 22d birthday). See 
Premarket Assessment of Pediatric Medical Devices (May 14, 2004); 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.
    For purposes of the requirements proposed in this document, FDA is 
proposing to codify a definition of the term ``pediatric patients'' as 
patients who are 21 years of age or younger (that is, from birth 
through the 21st year of life, up to but not including the 22d 
birthday) at the time of the diagnosis or treatment.

III. What applications are subject to this proposed rule?

    In accordance with the FD&C Act, the proposed requirements 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 would apply to the following applications 
when submitted on or after the effective date of the final rule:
     Any request for a humanitarian device exemption (HDE) 
submitted under section 520(m) of the FD&C Act;
     Any PMA or supplement to a PMA submitted under section 515 
of the FD&C Act; and
     Any product development protocol (PDP) submitted under 
section 515 of the FD&C Act.
    FDA concludes that section 515A applies to all submission types 
listed in the statute--PMA, HDE, PDP and all PMA supplements--not just 
the subset of PMA supplements that propose a new indication for use, as 
was proposed in the April 2010 proposed rule. The Agency also wants to 
clarify that it does not interpret 30-day notices submitted under 21 
CFR 814.39(f) to be PMA supplements for purposes of this proposed rule. 
Section 515(d)(6)(A) of the FD&C Act distinguishes between 
modifications to manufacturing procedures or methods of manufacture 
that affect the safety and effectiveness of a device subject to an 
approved PMA, which require the submission of a written notice, and 
other changes that affect safety and effectiveness and require the 
submission of a ``supplemental application.'' Because of this statutory 
distinction, 30-day notices are not considered PMA supplements for 
purposes of this proposed rule and,

[[Page 11614]]

therefore, are not required to include readily-available pediatric 
information.
    Moreover, an applicant submitting a PMA supplement is not required 
to resubmit previously submitted information satisfying the pediatric 
subpopulation requirements for the device, but may include the 
information by referring to the previous application or submission that 
contains the 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 premarket approval applications 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 FD&C Act in the final PMA module (i.e., the module that 
includes final clinical data, proposed labeling, and the Summary of 
Safety and Effectiveness Data).

 IV. What does this proposed rule do?

    This proposed rule would implement section 515A(a) of the FD&C Act 
by amending 21 CFR part 814, Premarket Approval of Medical Devices, to 
include requirements relating to the submission of readily available 
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 the applicant provide?

    This proposed rule would require 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. FDA is proposing 
to codify a definition of ``readily-available'' and also issue a draft 
guidance document to explain the Agency's current thinking on the 
meaning of ``readily-available information'' and how to comply with the 
requirements set forth in section 515A of the FD&C Act. The draft 
guidance document entitled ``Draft Guidance for Industry and Food and 
Drug Administration Staff: Providing Information About Pediatric Uses 
of Medical Devices Under Section 515A of the Federal Food, Drug, and 
Cosmetic Act'' is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm339162.htm.

B. What are the consequences of not submitting ``readily available'' 
information?

    If the applicant does not submit the information required by 
section 515A(a) of the FD&C Act, FDA may not approve the application 
until the applicant provides the required information. The Agency 
intends to contact the applicant during the normal course of our review 
to inform the applicant that the submission lacks the information 
required by section 515A(a) of the FD&C Act and by this proposed rule, 
and to ask the applicant to amend the application to provide the 
required information. If the 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 FD&C Act, the Agency intends to send the applicant an 
``approvable'' letter informing them that FDA will approve the 
application after the applicant provides the information required by 
section 515A(a). If the application has other deficiencies or does not 
meet all applicable statutory and regulatory requirements for approval, 
the Agency intends to send the applicant a ``not approvable'' letter or 
a ``major deficiency'' letter describing what information or data the 
applicant needs to provide before FDA can approve the 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 ``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?

    Section 302 of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Pub. L. 110-85), amended the FD&C Act by adding, among 
other things, a new section 515A (21 U.S.C. 360e-1). Section 515A(a) of 
the FD&C Act requires persons who submit certain medical device 
applications 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. Therefore, FDA is publishing this proposed 
rule under sections 515A(a) and 701(a) of the FD&C Act (21 U.S.C. 371) 
(which provides FDA the authority to issue regulations for the 
efficient enforcement of the FD&C Act). The Food and Drug 
Administration Safety and Innovation Act directs FDA to issue a 
proposed rule implementing section 515A(a) of the FD&C Act by December 
31, 2012, and final rule by December 31, 2013.

VI. What is the environmental impact of this proposed rule?

    FDA 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.

VII. What is the economic impact of this proposed rule?

    We have 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 will not be 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 this regulation only requires some 
submissions include a small amount of readily available information at 
about $80 per submission, the Agency proposes to certify that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local,

[[Page 11615]]

and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $139 
million, using the most current (2011) Implicit Price Deflator for the 
Gross Domestic Product. We do not expect this proposed 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 (section VII of 
this document). 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. As explained in the 
Paperwork Reduction analysis, we expect to receive annually 40 PMAs and 
5 applications for HDEs. We also expect to receive 693 supplements that 
would include the pediatric use information required by section 515A(a) 
of the FD&C Act and this proposed rule.
    Based on our experience with similar requirements regarding readily 
available information, we estimate it would take 8 hours to gather and 
submit information for original applications and amendments to those 
applications. Because supplements can incorporate this information by 
reference if on a prior submission, we estimate it would take only 2 
hours to obtain and submit the required information on pediatric 
populations.
    The estimated time burden for all 45 annual applications is 360 
hours. For the 693 supplements, the time burden is an estimated 1,386 
hours for a total of 1,746 hours. The 2011 median wage for a compliance 
officer in the medical device manufacturing industry is $31.75 (Ref. 
1). Adjusting the wage by average private sector benefits of 29.6 
percent of total compensation, the benefits-adjusted wage is $45.10 
(Ref. 2). At this wage, the estimated cost of submitting an application 
with pediatric information is $361 or $16,236 for all supplements. The 
estimated cost of submitting pediatric information for a supplement is 
$90 or $62,508 for all annual supplements. The estimated cost of this 
proposed rule is $78,744.
    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.
    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 the Food and Drug Administration 
Amendments Act of 2007 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 
and the review time for each such device application.
    Description of Respondents: These requirements apply to applicants 
who submit the following applications on or after the effective date of 
this rule:
     Any request for an HDE submitted under section 520(m) of 
the FD&C Act;
     Any PMA or supplement to a PMA submitted under section 515 
of the FD&C Act;
     Any PDP submitted under section 515 of the FD&C Act.
    Burden: FDA estimates the burden of this collection of information 
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       responses
----------------------------------------------------------------------------------------------------------------
814.20(b)(13)...................              30               1              30               8             240
814.37(b)(2)....................              10               1              10               8              80
814.39(c)(2)....................             693               1             693               2           1,386
814.104(b)(6)...................               5               1               5               8              40
                                 -------------------------------------------------------------------------------
    Totals......................             738  ..............             738  ..............           1,746
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    All that is required is to gather, organize, and submit information 
that is readily available, using any approach that meets the 
requirements of section 515A(a) of the FD&C Act and this proposed rule. 
FDA expects to receive approximately 45 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 2010-2011. 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 693 supplements that 
will include the pediatric use information required by 515A(a) of the 
FD&C Act and this proposed rule. We believe that since the proposed 
rule would require that the applicant organize and submit only readily 
available information, no more than 8 hours will be required to comply 
with section 515A(a) of the FD&C Act and this proposed rule for 
original applications and amendments to those applications. 
Furthermore, because supplements may incorporate by reference readily-
available information on pediatric populations if submitted in

[[Page 11616]]

a prior submission, FDA estimates the average time to obtain and submit 
the information required by this proposed rule in a supplement to be 2 
hours. FDA estimates that the total burden created by this proposed 
rule is 1,786 hours.
    We based this estimate on our experience with similar information 
collection requirements and on consultations with the Interagency 
Pediatric Devices Working Group that 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.
    This proposed rule also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 814 subpart B have been approved under 0910-0231 and the 
collections of information in 21 CFR part 814 subpart H have been 
approved under 0910-0332.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a draft guidance that suggests, among other things, that submissions 
include an estimate of the number of pediatric patients with diseases 
or conditions for which the device can be used, but that are outside 
the approved or proposed indication if such uses are described or 
acknowledged in acceptable sources of readily available information.

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. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. It is only necessary to send one set of 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, and will 
be posted to the docket at http://www.regulations.gov.

XI. References

    The following references have been placed on display in the 
Division of Dockets Management, 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. We have verified all the Web site 
addresses in the References section, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.
    1. U.S. Bureau of Labor Statistics, 2011 National Industry-Specific 
Occupational Employment and Wage Estimates, SOC 13-1041. http://www.bls.gov/oes/current/naics4_339100.htm.
    2. U.S. Bureau of Labor Statistics, Employer Costs for Employee 
Compensation, Table 5. Employer costs per hour worked for employee 
compensation and costs as a percent of total compensation: Private 
industry workers, by major occupational group and bargaining unit 
status, June 2012. http://www.bls.gov/news.release/ecec.t05.htm.

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

0
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.

0
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.
* * * * *
0
3. In Sec.  814.3, add paragraphs (p) and (q) to read as follows:


Sec.  814.3  Definitions.

* * * * *
    (p) Pediatric patients means patients who are 21 years of age or 
younger (that is, from birth through the 21st year of life, up to but 
not including the 22d birthday) at the time of the diagnosis or 
treatment.
    (q) Readily available means available in the public domain through 
commonly used public resources for conducting biomedical, regulatory, 
and medical product research.
0
4. In Sec.  814.20, redesignate paragraph (b)(13) as paragraph (b)(14) 
and add new paragraph (b)(13) to read as follows:


Sec.  814.20  Application.

* * * * *
    (b) * * *
    (13) Information concerning uses in pediatric patients. The 
application must include the following information, if readily 
available:
    (i) 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
    (ii) The number of affected pediatric patients.
* * * * *
0
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. Sec.  
814.20(b)(13) and 814.39(c)(2).
* * * * *
0
6. In Sec.  814.39, redesignate paragraph (c) as (c)(1) and add 
paragraph (c)(2) to read as follows:

[[Page 11617]]

Sec.  814.39  PMA supplements.

* * * * *
    (c) * * *
    (2) The supplement must include the following information:
    (i) Information concerning pediatric uses as required under Sec.  
814.20(b)(13).
    (ii) If information concerning the device that is the subject of 
the supplement was previously submitted under Sec.  814.20(b)(13) or 
under this section in a previous supplement, the applicant is not 
required to resubmit the information, but may include the information 
by referring to the previous application or submission that contains 
the information. However, if additional information required under 
Sec.  814.20(b)(13) has become readily available to the applicant since 
the previous submission, the applicant must submit that information as 
part of the supplement.
* * * * *
0
7. In Sec.  814.44, redesignate paragraphs (e)(1)(ii) through (iv) as 
paragraphs (e)(1)(iii) through (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 pediatric 
uses required by Sec.  814.20(b)(13);
* * * * *
0
8. Amend Sec.  814.100 as follows:
0
a. Redesignate paragraphs (b) through (e) as paragraphs (d) through 
(g), respectively.
0
b. Redesignate paragraph (a) as paragraph (b), and remove the first 
sentence of newly redesignated paragraph (b); and
0
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:
    (1) 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.
* * * * *
0
9. Amend Sec.  814.104 as follows:
0
a. Revise the last sentence of paragraph (b)(4)(ii);
0
b. Revise the last sentence of paragraph (b)(5); and
0
c. Add paragraph (b)(6).
    The revisions and addition 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) Information concerning pediatric uses of the device, as 
required by Sec.  814.20(b)(13).
* * * * *
0
10. In 814.116, redesignate paragraphs (c)(2) through (4) as paragraphs 
(c)(3) through (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 pediatric 
uses of the device, as required by Sec.  814.20(b)(13);
* * * * *

    Dated: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03647 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P


