[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Pages 94382-94384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31006]



Food and Drug Administration

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

Medical Device User Fee and Modernization Act; Notice to Public 
of Web Site Location of Fiscal Year 2017 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the Web site 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) 
2017. 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 21, 

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

[[Page 94383]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Medical Device User Fee and Modernization Act; 
Notice to Public of Web Site Location of Fiscal Year 2017 Proposed 
Guidance Development.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 
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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 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.


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'') 
     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'').
    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 2017 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, FDA has committed to updating its Web site 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 
    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, removal of guidances 
that 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 

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 
another 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. In FY 2016, CDRH finalized 2 and withdrew 5 
of 12 draft guidances issued prior to October 1, 2010, and has been 
continuing to work towards finalizing the remaining draft guidances. 
Looking forward, in FY 2017, CDRH will strive to finalize, withdraw, or 
re-open the comment period for 50 percent of existing draft guidances 
issued prior to October 1, 2011. CDRH expects to renew or modify, as 
appropriate, these performance goals in FY 2017 and subsequent years.

[[Page 94384]]

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 has included these guidances topics on the FY 2017 B-List as we 
progress toward issuance of draft policies reflecting early stakeholder 
input as appropriate.
    We also welcome 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 500 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 Web site where 
CDRH has posted the ``A-list'' and ``B-list'' for FY 2017, CDRH has 
also posted a list of final guidance documents that issued in 2007, 
1997, 1987, and 1977.\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 2018, 
CDRH expects to provide a list of the final guidance documents that 
issued in 2008, 1998, 1988, and 1978; the annual notice for FY 2019 is 
expected to provide a list of the final guidance documents that issued 
in 2009, 1999, 1989, and 1979, 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.

    \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 

    In FY 2016, CDRH received comments regarding guidances issued in 
2006, 1996, and 1986, and has withdrawn 12 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 on this retrospective review list was revised, and revision of 
several guidance documents is also being considered as resources 
    Consistent with 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 Web site, feedback on any guidance is 
appreciated and will be considered.

III. Web Site Location of Guidance Lists

    This notice announces the Web site location of the document that 
provides the A and B lists of guidance documents, which CDRH is 
intending to publish during FY 2017. To access these two lists, visit 
FDA's Web site at http://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). Topics on 
this and past guidance priority lists may be removed or modified based 
on current priorities. 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 2016 list was mostly in agreement, and CDRH 
continued to work toward issuing the guidances on this list. In FY 
2016, CDRH issued 20 of 33 guidances on the FY 2016 list (14 from the 
A-list, 6 from the B-list). In addition, for the guidances that were on 
the FY 2016 A or B list but could not be published within FY 2016, and 
for which we received feedback that these guidances were of high 
priority, CDRH has recommitted to publish these guidances by placing 
them on the annual agenda for FY 2017, as appropriate.

    Dated: December 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31006 Filed 12-22-16; 8:45 am]