[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58429-58431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26721]



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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 2018 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 CDRH (or the Center) intends to publish in 
fiscal year (FY) 2018. 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 February 12, 
2018.

ADDRESSES: You may submit comments 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-2012-N-1021 for ``Notice to Public of Website Location of CDRH 
Fiscal Year 2018 Proposed Guidance Development.'' 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 
``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 (MDUFA III), Title II, Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-114), 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 2018 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 and will update these lists after considering public comments, 
where appropriate. 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,

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FDA has committed to updating its website in a timely manner to reflect 
the Agency's review of previously published guidance documents, 
including the deletion 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, removal 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 re-issuance 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, re-open 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 
2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1, 
2011, and has been continuing to work towards taking an action on the 
remaining draft guidances. Looking forward, in FY 2018, CDRH will 
strive to finalize, withdraw, or re-open the comment period for 50 
percent of existing draft guidances issued prior to October 1, 2012.

B. Earlier Stakeholder Involvement in Guidance Development

    CDRH has received feedback that stakeholders desire earlier 
involvement in the guidance process and has taken steps to create a 
mechanism to address this request. In FY 2016, in anticipation of 
guidance documents expected to be developed, CDRH sought stakeholder 
input regarding electromagnetic compatibility of electrically powered 
medical devices and regarding utilizing animal studies to evaluate the 
safety of organ preservation devices and solutions. FDA appreciated the 
feedback received and considered it in the development of these 
guidances. Demonstrating commitment to incorporating stakeholder input, 
CDRH issued a draft guidance in FY17 on utilizing animal studies to 
evaluate the safety of organ preservation devices, and is progressing 
toward issuance of draft policies reflecting early stakeholder input as 
appropriate.
    FDA also welcomes any additional feedback for improving the 
guidance program and the quality of CDRH guidance documents.

C. Applicability of Previously Issued Final Guidance

    CDRH has issued over 600 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 2018, CDRH has also 
posted a list of final guidance documents that issued in 2008, 1998, 
1988, and 1978.\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 2019, 
CDRH expects to provide a list of the final guidance documents that 
issued in 2009, 1999, 1989, and 1979; the annual notice for FY 2020 is 
expected to provide a list of the final guidance documents that issued 
in 2010, 2000, 1990, and 1980, 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 
the following: (1) Documents that are not guidances but were 
inadvertently categorized as guidance such as scientific 
publications, advisory opinions, and interagency agreements; (2) 
guidances actively being revised by CDRH; and (3) special controls 
documents.
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    In FY 2017, CDRH received comments regarding guidances issued in 
2007, 1997, and 1987, and has withdrawn 32 guidance documents in 
response to comments received and because these guidance documents were 
determined to no longer represent the Agency's current thinking. 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 2018. To access these two lists, visit 
FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.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 2017 list was mostly in agreement, and CDRH 
continued to work toward issuing the guidances on this list. In FY 
2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-
list, 3 from the B-list). At this time, CDRH has decided not to pursue 
several guidances that were on the FY 2017 A or B list, due to factors 
including feedback from industry.


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    Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26721 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P