[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]



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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