[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Notices]
[Pages 7222-7223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2915]
[[Page 7222]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0062]
Medical Device Innovation Initiative; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``CDRH's Medical Device Innovation Initiative Public
Workshop.'' The purpose of the public meeting is to solicit feedback on
select actions outlined in the Center for Devices and Radiological
Health's (CDRH) document, ``Medical Device Innovation Initiative''
(report). FDA is seeking input on a number of identified challenges
associated with incentivizing innovation, and the proposed solutions.
In addition, the Agency requests comments on the Innovation Pathway
proposed under the report.
DATES: The public meeting will be held on March 15, 2011, from 8 a.m.
to 5:30 p.m. Persons interested in attending and/or participating in
the meeting must register by 5 p.m. on March 4, 2011.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 3502, Silver Spring, MD 20993.
A live Webcast of this meeting will be viewable on the day of the
meeting at http://fda.yorkcast.com/webcast/Viewer/?peid=fae7c7ac49174d159e49e8d83aaf3b9d. Closed captioning for this
Webcast will be available at http://www.speche.com/sbload.aspx?Load=Web,All,New&Height=90%&Width=100%&ClientID=31213.
Submit electronic comments 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.
Contact Person: Jonathan Sackner-Bernstein, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Avenue, Bldg. 66, Rm. 5410, Silver Spring, MD 20993, 301-796-
5420, e-mail: [email protected].
Registration and Requests for Oral Presentations: If you wish to
attend the public meeting, you must register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm241095.htm. Provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. Registration requests should be received by March 4, 2011.
If you wish to make an oral presentation during any of the open
comment sessions at the meeting, you must indicate this at the time of
registration. FDA has included general discussion topics and specific
questions for comment in this document. You should also identify which
discussion topic you wish to address in your presentation. In order to
keep each open session focused on the discussion topic at hand, each
oral presentation should address only one discussion topic. FDA will do
its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is to
begin.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
Non-U.S. citizens are subject to additional security screening, and
they should register as soon as possible. If you need special
accommodations due to a disability, please contact Susan Monahan,
[email protected], 301-796-5661, at least 7 days in advance of
the public meeting.
SUPPLEMENTARY INFORMATION:
I. Background
The United States is the global leader in medical device innovation
and CDRH is committed to assuring that American patients have timely
access to important new technologies and next-generation products
without compromising their safety. Each year, millions of American
patients benefit from innovative medical devices that reduce suffering,
treat previously untreatable conditions, extend lives, and improve
public health.
CDRH is responsible for advancing public health and facilitating
innovation to help bring novel technologies to market and make the
medical devices that are already on the market safer and more
effective. Recently, CDRH announced 25 actions it will take in 2011 to
strengthen its most widely-used premarket review process--the 510(k)
program--and increase its use of emerging science to foster innovation
and improve the predictability, consistency, and transparency of its
decisionmaking.\1\ These actions will not only improve the safety of
medical devices but also increase the ability of innovating companies
to attract investors, estimate costs, and more quickly bring products
to market.
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\1\ See ``510(k) and Science Report Recommendations: Summary and
Overview of Comments and Next Steps.'' Available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239449.pdf, and ``Plan of Action for Implementation of 510(k) and
Science Recommendations.'' Available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf.
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The Medical Device Innovation Initiative proposes the following
actions CDRH might take to help accelerate the development and
regulatory evaluation of innovative devices safely and based on sound
science:
Facilitate the development and regulatory evaluation of
innovative medical devices;
Strengthen the U.S. research infrastructure and promote
high-quality regulatory science; and
Prepare for, and respond to, transformative innovative
technologies and scientific breakthroughs.
Part of the Medical Device Innovation Initiative would consider the
creation of a special Innovation Pathway intended to provide earlier
investment of CDRH time and resources in devices that are true
pioneering technologies and that have the potential to revolutionize
patient care or health care delivery. By front-loading critical
aspects, such as identifying clinical endpoints and key scientific
questions, and seeking advice from external experts, the Innovation
Pathway would facilitate a more efficient regulatory review process for
transformative devices.
The objective of this public meeting is to receive public input on
the proposals to facilitate medical device innovation as set forth in
the report. The public meeting's focus includes the following areas:
The Innovation Pathway and Horizon Scanning (morning
session)
Clinical Test Center Certification, Core Curriculum for
Medical Device Development, and Regulatory Science (afternoon session)
During the meeting, FDA staff will present a brief overview of each
of the previously listed areas. Each of the FDA presentations will be
followed by an open comment session, during which members of the public
may present oral comments related to the topic under
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discussion. As described previously in this document, individuals who
are interested in making an oral presentation during any of the open
comment sessions must indicate this at the time of registration, must
identify which discussion topic they intend to address (see
Registration and Requests for Oral Presentations), and must submit
their presentations in advance. In order to keep each open session
focused on the discussion topic at hand, each oral presentation should
address only one discussion topic. Commenters are free to submit
comments on any discussion topic(s) to the open docket (see II.
Comments). FDA will schedule speakers for each open session as time
permits.
After each of the open comment sessions, there will be a panel
discussion between FDA staff and selected participants representing a
range of constituencies. The participants in the panel discussions will
reflect on the presentations and comments, engage in a dialogue with
each other and FDA staff, and provide closing thoughts for each
session. The participants will not be asked to develop consensus
opinions during the discussion, but rather to provide their individual
perspectives. Others in attendance at the meeting will have an
opportunity to listen to the panel discussions.
In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule for each open comment session,
will be made available on the Internet. This information will be placed
on file in the public docket (docket number found in brackets in the
heading of this document), which is available at http://www.regulations.gov. This information will also be available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm241095.htm.
II. Comments
FDA is holding this public meeting to obtain information on a
number of questions regarding medical device innovation. The deadline
for submitting comments related to this public meeting is March 15,
2011.
Regardless of attendance at the public meeting, interested persons
may submit to the Division of Dockets Management (see ADDRESSES) either
electronic or written comments. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in this document, please identify the question
you are addressing. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (HFI-35), Office of
Management Programs, Food and Drug Administration, 5600 Fishers Lane,
Rm. 6-30, Rockville, MD 20857.
Dated: February 4, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2915 Filed 2-8-11; 8:45 am]
BILLING CODE 4160-01-P