[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1424-1427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00115]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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'')
and
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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
Agency.
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
notice.
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
implementation.
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
taken.
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.
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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
devices.
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
pathologies?
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
response.
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
instrumentation?
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
effectiveness?
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
accomplished?
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.
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\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.
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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]
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