83_FR_7084 83 FR 7051 - How To Prepare a Pre-Request for Designation; Guidance for Industry; Availability

83 FR 7051 - How To Prepare a Pre-Request for Designation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 33 (February 16, 2018)

Page Range7051-7052
FR Document2018-03230

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance is to explain the Pre-RFD process at the FDA Office of Combination Products (OCP), describe and help a sponsor understand the type of information that the sponsor should include in a Pre-RFD, and assist sponsors in obtaining a preliminary assessment from FDA through the Pre-RFD process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product's assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)) for premarket review and regulation.

Federal Register, Volume 83 Issue 33 (Friday, February 16, 2018)
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7051-7052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0040]


How To Prepare a Pre-Request for Designation; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``How to Prepare a 
Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance 
is to explain the Pre-RFD process at the FDA Office of Combination 
Products (OCP), describe and help a sponsor understand the type of 
information that the sponsor should include in a Pre-RFD, and assist 
sponsors in obtaining a preliminary assessment from FDA through the 
Pre-RFD process. The Pre-RFD process is available to provide informal, 
non-binding feedback regarding the regulatory identity or 
classification of a human medical product as a drug, device, biological 
product, or combination product. In addition, this informal process 
provides information about a non-combination or combination product's 
assignment to the appropriate Agency Center (Center for Drug Evaluation 
and Research (CDER), Center for Devices and Radiological Health (CDRH), 
or Center for Biologics Evaluation and Research (CBER)) for premarket 
review and regulation.

DATES: The announcement of the guidance is published in the Federal 
Register on February 16, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-0040 for ``How to Prepare a Pre-Request for Designation 
(Pre-RFD); Guidance for Industry.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states

[[Page 7052]]

``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for a single copies of this guidance 
entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD)'' to 
the Office of Combination Products, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.

SUPPLEMENTARY INFORMATION:

I. Background

    Since its establishment on December 24, 2002, OCP has served as a 
resource for sponsors at various stages of development of their 
products. Sponsors often seek OCP feedback on whether their human 
medical product will be regulated as a drug, a device, a biologic, or a 
combination product, and which FDA medical product Agency Center (CDER, 
CBER, or CDRH) will regulate it, if it is a non-combination product, or 
will have the primary jurisdiction for the premarket review and 
regulation of the product, if it is a combination product.
    There are two ways that a sponsor can receive such a feedback from 
OCP. One option is to submit an RFD to receive a formal, binding 
determination for the sponsor's product with respect to classification 
and/or center assignment that may be changed under conditions specified 
in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is 
codified in 21 CFR part 3, and OCP has issued a guidance about this 
process (see ``How to Write a Request for Designation'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second 
more flexible option is for a sponsor to submit an inquiry to OCP to 
receive a preliminary jurisdictional assessment, which is not binding.
    Many sponsors seek to utilize a more flexible, approachable way to 
interact with OCP and the medical product Agency Centers, to obtain 
feedback from the Agency before submitting a marketing application to 
the Agency. Over time, these informal methods of obtaining feedback 
have become increasingly customary with sponsors, and for some, even 
preferable to the formal RFD process. Accordingly, FDA is enhancing the 
transparency and consistency of such interaction, which will now be 
called the ``Pre-Request for Designation (Pre-RFD) Program.''
    This guidance describes this structured process with clear 
recommendations for sponsors wishing to submit Pre-RFDs. It also 
provides the process for review of Pre-RFDs by FDA staff, the general 
timeframes for sponsors to receive feedback from OCP, and the process 
for scheduling teleconferences and meetings in relation to a Pre-RFD.
    FDA carefully considered the comments received on the draft 
guidance, and, where appropriate, has revised the guidance to reflect 
such comments. FDA encourages stakeholders to contact OCP if they have 
additional questions.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on how to prepare a Pre-RFD. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance 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 (44 U.S.C. 3501-3520). The 
collections of information in this guidance regarding how to prepare a 
Pre-RFD have been approved under OMB control number 0910-0845.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm534661.htm.

    Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03230 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P



                                                                             Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices                                           7051

                                               0002. Send one self-addressed adhesive                  III. Electronic Access                                Electronic Submissions
                                               label to assist that office in processing                                                                       Submit electronic comments in the
                                               your requests. See the SUPPLEMENTARY                      Persons with access to the internet
                                                                                                       may obtain the guidance at either                     following way:
                                               INFORMATION section for electronic                                                                              • Federal eRulemaking Portal:
                                               access to the guidance document.                        https://www.fda.gov/Drugs/Guidance
                                                                                                       ComplianceRegulatoryInformation/                      https://www.regulations.gov. Follow the
                                               FOR FURTHER INFORMATION CONTACT:                        Guidances/default.htm or https://                     instructions for submitting comments.
                                               Colleen Locicero, Center for Drug                       www.regulations.gov.                                  Comments submitted electronically,
                                               Evaluation and Research, Food and                                                                             including attachments, to https://
                                                                                                         Dated: February 12, 2018.
                                               Drug Administration, 10903 New                                                                                www.regulations.gov will be posted to
                                               Hampshire Ave., Bldg. 22, Rm. 4242,                     Leslie Kux,                                           the docket unchanged. Because your
                                               Silver Spring, MD 20993–0002, 301–                      Associate Commissioner for Policy.                    comment will be made public, you are
                                               796–1114.                                               [FR Doc. 2018–03225 Filed 2–15–18; 8:45 am]           solely responsible for ensuring that your
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       BILLING CODE 4164–01–P                                comment does not include any
                                                                                                                                                             confidential information that you or a
                                               I. Background                                                                                                 third party may not wish to be posted,
                                                                                                       DEPARTMENT OF HEALTH AND                              such as medical information, your or
                                                  FDA is announcing the availability of                HUMAN SERVICES                                        anyone else’s Social Security number, or
                                               a guidance for industry entitled
                                                                                                                                                             confidential business information, such
                                               ‘‘Duchenne Muscular Dystrophy and                       Food and Drug Administration                          as a manufacturing process. Please note
                                               Related Dystrophinopathies: Developing
                                                                                                                                                             that if you include your name, contact
                                               Drugs for Treatment.’’ DMD and other                    [Docket No. FDA–2017–D–0040]                          information, or other information that
                                               dystrophinopathies result from genetic
                                                                                                                                                             identifies you in the body of your
                                               mutations in the dystrophin gene that                   How To Prepare a Pre-Request for                      comments, that information will be
                                               decrease levels of dystrophin and/or                    Designation; Guidance for Industry;                   posted on https://www.regulations.gov.
                                               cause dysfunction of the dystrophin                     Availability                                            • If you want to submit a comment
                                               protein, leading to muscle degeneration,                                                                      with confidential information that you
                                               including cardiac and respiratory                       AGENCY:    Food and Drug Administration,
                                                                                                                                                             do not wish to be made available to the
                                               muscles, and greatly decreased life                     HHS.
                                                                                                                                                             public, submit the comment as a
                                               expectancy. There remains a high-level                  ACTION:   Notice of availability.                     written/paper submission and in the
                                               unmet medical need for effective drug                                                                         manner detailed (see ‘‘Written/Paper
                                               treatments for DMD and other                            SUMMARY:   The Food and Drug                          Submissions’’ and ‘‘Instructions’’).
                                               dystrophinopathies. This guidance                       Administration (FDA) is announcing the
                                               addresses FDA’s current thinking                        availability of a guidance for industry               Written/Paper Submissions
                                               regarding the clinical development                      entitled ‘‘How to Prepare a Pre-Request                  Submit written/paper submissions as
                                               program and clinical trial designs for                  for Designation (Pre-RFD).’’ The purpose              follows:
                                               drugs to support an indication for the                  of this guidance is to explain the Pre-                  • Mail/Hand delivery/Courier (for
                                               treatment of dystrophinopathies. This                   RFD process at the FDA Office of                      written/paper submissions): Dockets
                                               guidance finalizes the draft guidance of                Combination Products (OCP), describe                  Management Staff (HFA–305), Food and
                                               the same name issued June 10, 2015 (80                  and help a sponsor understand the type                Drug Administration, 5630 Fishers
                                               FR 32961). It reflects FDA’s                            of information that the sponsor should                Lane, Rm. 1061, Rockville, MD 20852.
                                               consideration of public comments on                     include in a Pre-RFD, and assist                         • For written/paper comments
                                               the draft guidance and makes minor                      sponsors in obtaining a preliminary                   submitted to the Dockets Management
                                               clarifying changes.                                     assessment from FDA through the Pre-                  Staff, FDA will post your comment, as
                                                  This guidance is being issued                        RFD process. The Pre-RFD process is                   well as any attachments, except for
                                               consistent with FDA’s good guidance                     available to provide informal, non-                   information submitted, marked and
                                               practices regulation (21 CFR 10.115).                   binding feedback regarding the                        identified, as confidential, if submitted
                                               The guidance represents the current                     regulatory identity or classification of a            as detailed in ‘‘Instructions.’’
                                               thinking of FDA on developing drugs for                 human medical product as a drug,                         Instructions: All submissions received
                                               the treatment of DMD. It does not                       device, biological product, or                        must include the Docket No. FDA–
                                               establish any rights for any person and                 combination product. In addition, this                2017–D–0040 for ‘‘How to Prepare a Pre-
                                               is not binding on FDA or the public.                    informal process provides information                 Request for Designation (Pre-RFD);
                                               You can use an alternative approach if                  about a non-combination or                            Guidance for Industry.’’ Received
                                               it satisfies the requirements of the                    combination product’s assignment to                   comments will be placed in the docket
                                               applicable statutes and regulations. This               the appropriate Agency Center (Center                 and, except for those submitted as
                                               guidance is not subject to Executive                    for Drug Evaluation and Research                      ‘‘Confidential Submissions,’’ publicly
                                               Order 12866.                                            (CDER), Center for Devices and                        viewable at https://www.regulations.gov
                                               II. Paperwork Reduction Act of 1995                     Radiological Health (CDRH), or Center                 or at the Dockets Management Staff
                                                                                                       for Biologics Evaluation and Research                 between 9 a.m. and 4 p.m., Monday
                                                 This guidance refers to previously                    (CBER)) for premarket review and                      through Friday.
                                               approved collections of information that                regulation.                                              • Confidential Submissions—To
                                               are subject to review by the Office of                                                                        submit a comment with confidential
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                                               Management and Budget (OMB) under                       DATES: The announcement of the                        information that you do not wish to be
                                               the Paperwork Reduction Act of 1995                     guidance is published in the Federal                  made publicly available, submit your
                                               (44 U.S.C. 3501–3520). The collections                  Register on February 16, 2018.                        comments only as a written/paper
                                               of information in 21 CFR parts 312 and                  ADDRESSES:   You may submit either                    submission. You should submit two
                                               314 have been approved under OMB                        electronic or written comments on                     copies total. One copy will include the
                                               control numbers 0910–0014 and 0910–                     Agency guidances at any time as                       information you claim to be confidential
                                               0001, respectively.                                     follows:                                              with a heading or cover note that states


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                                               7052                          Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices

                                               ‘‘THIS DOCUMENT CONTAINS                                whether their human medical product                   for any person and is not binding on
                                               CONFIDENTIAL INFORMATION.’’ The                         will be regulated as a drug, a device, a              FDA or the public. You can use an
                                               Agency will review this copy, including                 biologic, or a combination product, and               alternative approach if it satisfies the
                                               the claimed confidential information, in                which FDA medical product Agency                      requirements of the applicable statutes
                                               its consideration of comments. The                      Center (CDER, CBER, or CDRH) will                     and regulations. This guidance is not
                                               second copy, which will have the                        regulate it, if it is a non-combination               subject to Executive Order 12866.
                                               claimed confidential information                        product, or will have the primary
                                                                                                                                                             II. Paperwork Reduction Act of 1995
                                               redacted/blacked out, will be available                 jurisdiction for the premarket review
                                               for public viewing and posted on                        and regulation of the product, if it is a                This guidance refers to previously
                                               https://www.regulations.gov. Submit                     combination product.                                  approved collections of information
                                               both copies to the Dockets Management                      There are two ways that a sponsor can              found in FDA regulations. These
                                               Staff. If you do not wish your name and                 receive such a feedback from OCP. One                 collections of information are subject to
                                               contact information to be made publicly                 option is to submit an RFD to receive a               review by the Office of Management and
                                               available, you can provide this                         formal, binding determination for the                 Budget (OMB) under the Paperwork
                                               information on the cover sheet and not                  sponsor’s product with respect to                     Reduction Act of 1995 (44 U.S.C. 3501–
                                               in the body of your comments and you                    classification and/or center assignment               3520). The collections of information in
                                               must identify this information as                       that may be changed under conditions                  this guidance regarding how to prepare
                                               ‘‘confidential.’’ Any information marked                specified in section 563 of the Federal               a Pre-RFD have been approved under
                                               as ‘‘confidential’’ will not be disclosed               Food, Drug, and Cosmetic Act (21 U.S.C.               OMB control number 0910–0845.
                                               except in accordance with 21 CFR 10.20                  360bbb–2) and 21 CFR 3.9 in the                       III. Electronic Access
                                               and other applicable disclosure law. For                regulations. The RFD process is codified
                                                                                                       in 21 CFR part 3, and OCP has issued                     Persons with access to the internet
                                               more information about FDA’s posting
                                                                                                       a guidance about this process (see ‘‘How              may obtain the document at https://
                                               of comments to public dockets, see 80
                                                                                                       to Write a Request for Designation’’ at               www.fda.gov/RegulatoryInformation/
                                               FR 56469, September 18, 2015, or access
                                                                                                       https://www.fda.gov/                                  Guidances/ucm534661.htm.
                                               the information at: https://www.gpo.gov/
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                       RegulatoryInformation/Guidances/                        Dated: February 12, 2018.
                                               23389.pdf.                                              ucm126053.htm). A second more                         Leslie Kux,
                                                  Docket: For access to the docket to                  flexible option is for a sponsor to submit            Associate Commissioner for Policy.
                                               read background documents or the                        an inquiry to OCP to receive a                        [FR Doc. 2018–03230 Filed 2–15–18; 8:45 am]
                                               electronic and written/paper comments                   preliminary jurisdictional assessment,
                                                                                                                                                             BILLING CODE 4164–01–P
                                               received, go to https://                                which is not binding.
                                               www.regulations.gov and insert the                         Many sponsors seek to utilize a more
                                               docket number, found in brackets in the                 flexible, approachable way to interact                DEPARTMENT OF HEALTH AND
                                               heading of this document, into the                      with OCP and the medical product                      HUMAN SERVICES
                                               ‘‘Search’’ box and follow the prompts                   Agency Centers, to obtain feedback from
                                               and/or go to the Dockets Management                     the Agency before submitting a                        Food and Drug Administration
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     marketing application to the Agency.
                                                                                                       Over time, these informal methods of                  [Docket No. FDA–2018–N–0404]
                                               Rockville, MD 20852.
                                                  You may submit comments on any                       obtaining feedback have become
                                                                                                                                                             Pediatric Medical Device Development;
                                               guidance at any time (see 21 CFR                        increasingly customary with sponsors,
                                                                                                                                                             Public Meeting; Request for Comments
                                               10.115(g)(5)).                                          and for some, even preferable to the
                                                  Submit written requests for a single                 formal RFD process. Accordingly, FDA                  AGENCY:    Food and Drug Administration,
                                               copies of this guidance entitled ‘‘How to               is enhancing the transparency and                     HHS.
                                               Prepare a Pre-Request for Designation                   consistency of such interaction, which                ACTION: Notice of public meeting;
                                               (Pre-RFD)’’ to the Office of Combination                will now be called the ‘‘Pre-Request for              request for comments.
                                               Products, Food and Drug                                 Designation (Pre-RFD) Program.’’
                                                                                                          This guidance describes this                       SUMMARY:    The Food and Drug
                                               Administration, 10903 New Hampshire                                                                           Administration (FDA, the Agency, or
                                                                                                       structured process with clear
                                               Ave., Bldg. 32, Rm. 5129, Silver Spring,                                                                      we) is announcing the following public
                                                                                                       recommendations for sponsors wishing
                                               MD 20993–0002. Send one self-                                                                                 meeting entitled ‘‘Pediatric Medical
                                                                                                       to submit Pre-RFDs. It also provides the
                                               addressed adhesive label to assist that                                                                       Device Development.’’ The purpose of
                                                                                                       process for review of Pre-RFDs by FDA
                                               office in processing your request. See                                                                        the public meeting is to identify
                                                                                                       staff, the general timeframes for
                                               the SUPPLEMENTARY INFORMATION section                                                                         strategies to enhance the medical device
                                                                                                       sponsors to receive feedback from OCP,
                                               for electronic access to the guidance                                                                         ecosystem to cultivate development and
                                                                                                       and the process for scheduling
                                               document.                                                                                                     innovation of devices that serve the
                                                                                                       teleconferences and meetings in relation
                                               FOR FURTHER INFORMATION CONTACT:                        to a Pre-RFD.                                         unique needs of pediatric populations.
                                               Leigh Hayes, Office of Combination                         FDA carefully considered the                       (The Federal Food, Drug, and Cosmetic
                                               Products, Food and Drug                                 comments received on the draft                        Act (FD&C Act) defines pediatric
                                               Administration, 10903 New Hampshire                     guidance, and, where appropriate, has                 patients, for medical device purposes, as
                                               Ave., Bldg. 32, Rm. 5129, Silver Spring,                revised the guidance to reflect such                  age 21 years or younger at the time of
                                               MD 20993–0002, 301–796–8930.                            comments. FDA encourages                              diagnosis or treatment and specifies
                                               SUPPLEMENTARY INFORMATION:                              stakeholders to contact OCP if they have              categories of pediatric subpopulations.)
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                                                                                                       additional questions.                                 Topics for discussion will include ways
                                               I. Background                                              This guidance is being issued                      to improve research infrastructure and
                                                  Since its establishment on December                  consistent with FDA’s good guidance                   research networks to facilitate the
                                               24, 2002, OCP has served as a resource                  practices regulation (21 CFR 10.115).                 conduct of clinical studies of pediatric
                                               for sponsors at various stages of                       The guidance represents the Agency’s                  devices, extrapolation, use of
                                               development of their products.                          current thinking on how to prepare a                  postmarket registries and data to
                                               Sponsors often seek OCP feedback on                     Pre-RFD. It does not establish any rights             increase pediatric medical device


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Document Created: 2018-02-16 00:55:38
Document Modified: 2018-02-16 00:55:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on February 16, 2018.
ContactLeigh Hayes, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.
FR Citation83 FR 7051 

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