[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50107-50109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]


Notice to Public of Website Location of Center for Devices and 
Radiological Health Fiscal Year 2019 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the website location where the Agency will post two lists of 
guidance documents that the Center for Devices and Radiological Health 
(CDRH or the Center) intends to publish in fiscal year (FY) 2019. In 
addition, FDA has established a docket where interested persons may 
comment on the priority of topics for guidance, provide comments and/or 
propose draft language for those topics, suggest topics for new or 
different guidance documents, comment on the applicability of guidance 
documents that have issued previously, and provide any other comments 
that could benefit the CDRH guidance program and its engagement with 
stakeholders. This feedback is critical to the CDRH guidance program to 
ensure that we meet stakeholder needs.

DATES: Submit either electronic or written comments by December 3, 
2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 3, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 3, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2012-N-1021 for ``Notice to Public of website Location of CDRH 
Fiscal Year 2019 Proposed Guidance Development.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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

[[Page 50108]]

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 ``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.gpo.gov/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.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION: 

I. Background

    During negotiations on the Medical Device User Fee Amendments of 
2012, Title II, Food and Drug Administration Safety and Innovation Act 
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. Among these commitments included:
     Annually posting a list of priority medical device 
guidance documents that the Agency intends to publish within 12 months 
of the date this list is published each fiscal year (the ``A-list''), 
and
     Annually posting a list of device guidance documents that 
the Agency intends to publish, as the Agency's guidance-development 
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA 
Reauthorization Act of 2017 (Pub. L. 115-52) maintained these 
commitments.
    FDA welcomes comments on any or all of the guidance documents on 
the lists as explained in 21 CFR 10.115(f)(5). FDA has established 
Docket No. FDA-2012-N-1021 where comments on the FY 2019 lists, draft 
language for guidance documents on those topics, suggestions for new or 
different guidances, and relative priority of guidance documents may be 
submitted and shared with the public (see ADDRESSES). FDA believes this 
docket is a valuable tool for receiving information from interested 
persons. FDA anticipates that feedback from interested persons will 
allow CDRH to better prioritize and more efficiently draft guidances to 
meet the needs of the Agency and our stakeholders.
    In addition to posting the lists of prioritized device guidance 
documents, FDA has committed to updating its website in a timely manner 
to reflect the Agency's review of previously published guidance 
documents, including the withdrawal of guidance documents that no 
longer represent the Agency's interpretation of or policy on a 
regulatory issue.
    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, withdrawal of 
guidances that no longer reflect FDA's current thinking on a particular 
topic, and annual updates to the A-list and B-list announced in this 
notice.

II. CDRH Guidance Development Initiatives

A. Finalization of Draft Guidance Documents

    CDRH has identified as a priority, and has devoted resources to, 
finalization of draft guidance documents. To assure the timely 
completion or reissuance of draft guidances, in FY 2015 CDRH committed 
to performance goals for current and future draft guidance documents. 
For draft guidance documents issued after October 1, 2014, CDRH 
committed to finalize, withdraw, reopen the comment period, or issue 
new draft guidance on the topic for 80 percent of the documents within 
3 years of the close of the comment period and for the remaining 20 
percent, within 5 years. As part of MDUFA IV commitments, FDA 
reaffirmed this commitment, as resources permit. In addition, in FY 
2018, CDRH withdrew two draft guidances and reopened the comment period 
for two draft guidances of six draft guidances issued prior to October 
1, 2012, and has been continuing to work towards taking an action on 
the remaining draft guidances. Looking forward, in FY 2019, CDRH will 
strive to finalize, withdraw, or reopen the comment period for 50 
percent of existing draft guidances issued prior to October 1, 2013.

B. Applicability of Previously Issued Final Guidance

    CDRH has issued over 450 final guidance documents to provide 
stakeholders with the Agency's thinking on numerous topics. Each 
guidance reflected the Agency's current position at the time that it 
was issued. However, the guidance program has issued these guidances 
over a period of 30 years, raising the question of how current 
previously issued final guidances remain. CDRH has resolved to address 
this concern through a staged review of previously issued final 
guidances in collaboration with stakeholders. At the website where CDRH 
has posted the ``A-list'' and ``B-list'' for FY 2019, CDRH has also 
posted a list of final guidance documents that issued in 2009, 1999, 
1989, and 1979.\1\ CDRH is interested in external feedback on whether 
any of these final guidances should be revised or withdrawn. In 
addition, for guidances that are recommended for revision, information 
explaining the need for revision, such as the impact and risk to public 
health associated with not revising the guidance, would also be helpful 
as the Center considers potential action with respect to these 
guidances. CDRH intends to provide these lists of previously issued 
final guidances annually through FY 2025 so that by 2025, FDA and 
stakeholders will have assessed the applicability of all guidances 
older than 10 years. For instance, in the annual notice for FY 2020, 
CDRH expects to provide a list of the final guidance documents that 
issued in 2010, 2000, 1990, and 1980; the annual notice for FY 2021 is 
expected to provide a list of the final guidance documents that issued 
in 2011, 2001, 1991, and 1981, and so on. CDRH will consider the 
comments received from this retrospective review when determining 
priorities for updating guidance documents and will revise these as 
resources permit.
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    \1\ The retrospective list of final guidances does not include 
special controls documents.
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    In FY 2018, CDRH received comments regarding guidances issued in 
2008,

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1998, and 1988, and has withdrawn fourteen guidance documents in 
response to comments received and because these guidance documents were 
determined to no longer represent the Agency's current thinking. One 
guidance has been revised and issued as a draft guidance, and the 
revision of several guidance documents is also being considered as 
resources permit.
    Consistent with the Good Guidance Practices regulation at 21 CFR 
10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or 
withdraw an already existing guidance document. We request that the 
suggestion clearly explain why the guidance document should be revised 
or withdrawn and, if applicable, how it should be revised. While we are 
requesting feedback on the list of previously issued final guidances 
located in the annual agenda website, feedback on any guidance is 
appreciated and will be considered.

III. Website Location of Guidance Lists

    This notice announces the website location of the document that 
provides the A and B lists of guidance documents, which CDRH is 
intending to publish during FY 2019. To access these two lists, visit 
FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm529396.htm. We note 
that the topics on this and past guidance priority lists may be removed 
or modified based on current priorities, as well as comments received 
regarding these lists. Furthermore, FDA and CDRH priorities are subject 
to change at any time (e.g., newly identified safety issues). The 
Agency is not required to publish every guidance on either list if the 
resources needed would be to the detriment of meeting quantitative 
review timelines and statutory obligations. In addition, the Agency is 
not precluded from issuing guidance documents that are not on either 
list.
    Stakeholder feedback on guidance priorities is important to ensure 
that the CDRH guidance program meets the needs of stakeholders. The 
feedback received on the FY 2018 list was mostly in agreement, and CDRH 
continued to work toward issuing the guidances on this list. In FY 
2018, CDRH issued sixteen of twenty guidances on the FY 2018 list 
(fourteen from the A-list, two from the B-list).

    Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21596 Filed 10-3-18; 8:45 am]
 BILLING CODE 4164-01-P


