[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Pages 1424-1427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00115]



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 2015 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) is intending to publish in Fiscal Year (FY) 
2015. In addition, FDA has established a docket, identified in brackets 
in the heading of this document, where stakeholders 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, and comment on the applicability of guidance documents that 
have issued previously.

DATES: You may submit either electronic or written comments at any 
time. FDA would appreciate if stakeholders provide feedback by March 
10, 2015.

ADDRESSES: Submit electronic comments on the proposed guidance to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Gadiock, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-796-5736.


I. Background

    During negotiations over 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, in return for additional 
funding from industry, to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. 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'') 

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     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 invites interested persons to submit comments on any or all of 
the guidance documents on the lists as explained in 21 CFR 
10.115(f)(5). FDA has established the docket number (FDA-2012-N-1021) 
where comments on the FY 2015 lists, draft language for guidance 
documents on those topics, suggestions for new or different guidances, 
and relative priority of guidance documents may be submitted (see 
ADDRESSES). FDA believes this docket is an important tool for receiving 
information from interested parties and for sharing this information 
with the public. FDA anticipates that feedback from stakeholders, 
including draft language for guidance documents, will allow CDRH to 
better prioritize and more efficiently draft guidances that will be 
useful to industry and other stakeholders. FDA intends to update these 
lists each year.
    Similar information about planned guidance development is included 
in the annual Agency-wide notice issued under its good guidance 
practices (GGPs) (Sec.  10.115(f)(5)). The CDRH lists, however, are 
focused exclusively on device-related guidances and will be made 
available on FDA's Web site at the beginning of each fiscal year from 
2013 to 2017.
    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 
issue, and notation of guidance documents that are under review by the 
    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. Guidance Development Process Workshop

    On June 5, 2014, CDRH held a public workshop to provide 
stakeholders an opportunity to actively engage with Center 
representatives about the guidance development process, provide 
transparency into guidance priority development, promote dialogue on 
guidance process improvements, and generate ideas for assessing the 
impact of guidance (http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm394821.htm). The workshop also provided a forum 
to discuss best practices in guidance development, including public 
participation in guidance development. CDRH carefully considered the 
comments and suggestions provided by stakeholders. The following is a 
summary of the issues discussed at the workshop, actions the Center has 
taken to date in response to the discussions, and plans for 

A. Draft Guidance Documents

    A concern raised by external stakeholders was CDRH's use of 
recommendations contained in draft guidance documents to make 
regulatory and enforcement decisions before the recommendations were 
established through issuance of a final guidance document. CDRH 
reaffirmed that the Center's policy has always been consistent with the 
Agency's GGPs, which state that a draft guidance document is issued for 
public comment purposes only and may not be implemented until finalized 
(Sec.  10.115(g)). However, CDRH agreed additional steps should be 
    Stakeholders requested that draft guidance documents be more 
clearly identified as ``draft'' to indicate to CDRH stakeholders and 
staff that they are not for implementation. CDRH revised its templates 
for new draft guidance documents by adding the watermark ``DRAFT'' to 
all pages in order to more conspicuously mark the guidance as not for 
implementation. CDRH implemented the use of the new templates effective 
August 6, 2014. CDRH also added the watermark ``DRAFT'' to draft 
guidance documents issued prior to August 6, 2014.
    Stakeholders also recommended that CDRH's guidance documents Web 
page (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm) list draft guidances separately from 
those that had been finalized, which would enhance searchability. CDRH 
revised its guidance document Web page to include a new left navigation 
item for ``Draft Guidance.'' In addition, CDRH removed draft guidance 
documents from the office guidance document lists and separated the 
link to ``Recent Medical Device Guidance Documents'' into two separate 
links: ``Recent Medical Device Final Guidance Documents'' and ``Recent 
Medical Device Draft Guidance Documents.''
    CDRH is aware there are some draft guidance documents that have not 
yet been finalized. In order to assure the timely completion or 
reissuance of draft guidances, CDRH is committing to performance goals 
for current and future draft guidance documents. For draft guidance 
documents issued after October 1, 2014, CDRH will finalize, withdraw, 
reopen 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. For draft guidances for which CDRH does not take action 
within the initial 3 years, CDRH will finalize, withdraw, reopen the 
comment period, or issue another draft guidance on the topic within 5 
years. In addition, in FY 2015, CDRH will finalize, withdraw, or reopen 
the comment period for 50 percent of existing draft guidances issued 
prior to October 1, 2009. CDRH expects to renew or modify, as 
appropriate, these performance goals in FY 2016 and subsequent years.

B. Earlier Stakeholder Involvement

    CDRH representatives discussed various ways in which the Center 
currently encourages participation by external stakeholders in the 
guidance development process. In addition to those described in the 
Background section, recently the Center has taken some new approaches 
to developing guidance documents. CDRH has held public workshops and 
panel meetings to solicit stakeholder feedback on both device-specific 
and policy-related issues. For example, this model was utilized for the 
development of the Design Considerations for Devices intended for Home 
Use Guidance (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM331681.pdf) prior to 
the draft guidance's issuance. However, because the resource 
implications for public meetings or workshops and panel meetings are 
very high, CDRH can only use these venues in limited cases. CDRH must 
judiciously balance various approaches to guidance development with 
meeting quantitative review timelines and other statutory obligations.
    In the case of emerging technologies, CDRH is using ``leapfrog'' 
guidances to provide initial recommendations regarding the type of 
information that would be appropriate in the review of emerging 
technologies. Information from external stakeholders helps CDRH 
formulate its initial thinking on the data necessary to support 
marketing approval or clearance of these devices.

[[Page 1426]]

    In anticipation of guidances that are expected to be developed, 
CDRH is posing the following questions to stakeholders for 
consideration and comment so that relevant future draft guidances on 
these technologies can be as complete and useful as possible. CDRH 
believes that stakeholder input at this stage and again after a draft 
guidance is issued on the topic will lead to a comprehensive and 
informed final guidance on the Agency's policy for the technologies and 
processes listed below:
1. Patient Matched Instrumentation for Orthopedics
    These devices are patient-specific instrumentation, created from 
patient imaging scans with the use of segmentation and planning 
software, to affect a surgeon's surgical plan intraoperatively. A 
guidance document addressing the basic elements to be addressed in a 
510(k) submission for patient matched instrumentation for all joint 
replacement product areas will help provide transparency to industry as 
to the level and types of information requested for review of these 
     What methods are used to determine that all phases of the 
design process, including those that rely on execution by a trained 
employee and/or by software, function as intended? How is variability 
controlled across planning personnel and across different patient 
     What impact does preoperative planning of the surgical 
procedure to create a guide have on implant performance? What 
parameters are critical to creating an effective preoperative plan with 
respect to device performance? Please provide a justification for your 
     How extensive is the interaction among the approving 
surgeon and the planning personnel when developing and approving a 
preoperative plan?
     When the manufacturers of patient-matched instruments do 
not manufacture the implant system or have a formal business agreement 
with the implant manufacturer, what information requires monitoring to 
ensure that modifications to the implant system or implantation 
recommendations do not affect the performance of the patient-matched 
2. Medical Devices Intended for Aesthetic Use
    As the U.S. population continues to age, use of medical devices for 
aesthetic purposes is expanding. Given the absence of generally 
accepted metrics for selecting patients and evaluating medical device 
performance for aesthetic uses, there are many challenges in collecting 
and interpreting clinical data that might support clearance or approval 
of aesthetic-use devices. Another difficulty in such studies is 
understanding patients' perspectives on product safety and 
effectiveness, which are important in defining the benefit/risk ratio 
for any new treatment. A guidance document on this topic would address 
development and validation of methods for quantitative measure of 
aesthetic improvement with minimal bias.
    Objective measures of device effectiveness can be difficult to 
develop and validate for endpoints involving aesthetic outcomes. 
However, tools to measure device effectiveness in an objective manner 
are needed in order to reduce bias in interpretation of study results.
     Do the use of validated scales that depict varying degrees 
of change in body features (e.g., wrinkle severity, mid-face volume) 
result in clinically meaningful assessment of product effectiveness? 
Under what circumstances would the use of a validated scale not be 
clinically meaningful?
     How can gender or ethnicity-specific tools be developed in 
order to gather clinically meaningful assessment of product 
     To what extent should emphasis be placed on the use of 
validated patient-reported outcome measures in order to demonstrate 
product effectiveness? Should assessment of the primary endpoint using 
a validated patient reported outcome measure be routine?
     Can photography methods find utility in assessment of 
product effectiveness and be comparable to live assessment when 
evaluating three-dimensional changes in tissue volume? If so, are there 
such methods in clinical use?
     Is there a role for creative or non-traditional methods 
(e.g., crowd sourcing, use of social media) in clinically meaningful 
assessment of product effectiveness? If so, how can this be 
3. Dual 510(k) and Clinical Laboratory Improvements Amendments (CLIA) 
Waiver by Application
    A Dual 510(k) and CLIA Waiver by Application (``Dual'') is a 
regulatory submission requesting both 510(k) clearance and CLIA Waiver 
approval. Under the Dual program, a Dual must be preceded by a 
presubmission during which the strategy for addressing both regulatory 
requirements is discussed. After the presubmission, the Dual 510(k) and 
Waiver by Application are submitted as a single regulatory submission. 
A guidance document addressing considerations for the design of 
clinical studies used to support both CLIA Waiver approval and 510(k) 
clearance will provide transparency on the level and types of 
information to provide FDA. FDA anticipates this will help focus the 
Dual presubmissions and potentially shorten the review process for the 
Dual submission.
     Of what challenges should FDA be aware in drafting this 
guidance document?
    Stakeholders are strongly encouraged to suggest guidance topics as 
well. In order to support their concept, commenters should state the 
potential guidance topic, reasons the guidance is needed, and proposed 
policy for FDA to consider on the topic. See Sec.  10.115(f)(2). 
Ideally, commenters would develop a comprehensive policy in the form of 
a proposed guidance document that CDRH could then consider issuing as 
draft guidance, as explained in Sec.  10.115(f)(2).

C. Applicability of Previously-Issued Final Guidance

    CDRH has issued over 1,000 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 greater than 20 years, raising the question of how 
current do 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 2015, CDRH has also posted a list of final guidance documents 
that issued in 2005, 1995, and 1985.\1\ The Center would appreciate 
external feedback on whether any of these final guidances should be 
revised or withdrawn. CDRH intends to provide such lists annually 
through FY 2025 so that by FY 2025, FDA and stakeholders will have 
assessed the applicability of all guidances older than 10 years. For 
instance, in the annual notice for FY 2016, CDRH expects to provide a 
list of the final guidance documents that issued in 2006, 1996, and 
1986; the annual notice for FY 2017 is expected

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to provide a list of the final guidance documents that issued in 2007, 
1997, and 1987, and so on. CDRH will consider the information received 
from this retrospective review when determining priorities for updating 
guidance documents. Based upon this experience, CDRH will establish a 
process for ongoing periodic review of final guidance that takes into 
account the value provided by the review and the resource implications 
to conduct the review.

    \1\ The retrospective list of final guidances does not include: 
(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.

    Under the GGPs regulation at Sec.  10.115(f)(4), the public may, at 
any time, suggest that CDRH revise or withdraw an already existing 
guidance document. The suggestion should address why the guidance 
document should be revised or withdrawn and, if applicable, how it 
should be revised. Stakeholders are advised to examine the list or 
previously issued final guidances provided by CDRH on the annual agenda 
Web site but feedback on any guidance is appreciated.

III. Web Site Location of Guidance Lists

    This notice announces the Web site location of the two lists of 
guidance documents which CDRH is intending to publish during FY 2015. 
To access these two lists, visit FDA's Web site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm. We note that 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. The Agency is not precluded from issuing guidance 
documents that are not on either list.
    FDA and CDRH priorities are subject to change at any time. Topics 
on this and past guidance priority lists may be removed or modified 
based on current priorities. CDRH's experience in guidance development 
has shown that there are many reasons that CDRH staff may not complete 
the entire agenda of guidances it undertakes. Staffs are frequently 
diverted from guidance development to other priority activities. In 
addition, at any time new issues may arise to be addressed in guidance 
that could not have been anticipated at the time the annual list is 
generated. These may involve newly identified public health issues.

IV. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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.

    Dated: January 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00115 Filed 1-8-15; 8:45 am]