[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Notices]
[Pages 29560-29561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0237]


Identifying Unmet Public Health Needs and Facilitating Innovation 
in Medical Device Development; Notice of Public Workshop; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Identifying Unmet Public Health Needs and 
Facilitating Innovation in Medical Device Development.'' The purpose of 
the workshop is to obtain public input on what are the most important 
unmet public health needs and what are the barriers to the development 
of medical devices that can cure, significantly improve, or prevent 
these illnesses and injuries.
    Dates and Times: This workshop will be held on June 24, 2010, from 
8 a.m. to 5 p.m. Persons interested in attending the meeting must 
register by 5 p.m. on June 10, 2010. Submit electronic or written 
comments by July 23, 2010.
    Location: The public workshop will be held at Hilton Washington DC/
North Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Melanie Fleming, Office of the Center Director, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5407, Silver 
Spring, MD 20993, 301-796-5424, FAX: 301-847-8510, 
[email protected].
    Registration and Requests for Oral Presentations: Interested 
persons may register at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from 
the list). Registrants must provide the following information: (1) 
name, (2) title, (3) company or organization (if applicable), (4) 
mailing address, (5) telephone number, and (6) e-mail address. There is 
no registration fee for the public workshop. Early registration is 
recommended because seating is limited. Registration on the day of the 
public workshop will be provided on a space available basis beginning 
at 7:30 a.m.
    If you wish to make an oral presentation during any of the open 
comment sessions at the meeting (see section II of this document), you 
must indicate this at the time of registration. FDA requests that 
presentations focus on the areas defined in section III of this 
document. You should also identify which discussion topic you wish to 
address in your presentation and you must submit a brief statement that 
describes your experience and/or expertise relevant to your proposed 
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.
    If you need special accommodations due to a disability, please 
contact Melanie Fleming (see Contact Person) at least 7 days in 
advance.
    Comments: FDA is holding this public workshop to obtain information 
on a number of specific questions regarding unmet public health needs 
and steps the Federal Government can take to reduce barriers to the 
development of medical devices that can cure, significantly improve, or 
prevent these illnesses and injuries. The deadline for submitting 
comments regarding this public workshop is July 23, 2010.
    Regardless of attendance at the public workshop, interested persons 
may submit electronic comments to http://www.regulations.gov, or 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. 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. In addition, when responding to specific questions as 
outlined in section III of 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health (CDRH) has 
undertaken an initiative to proactively facilitate medical device 
innovation to address unmet public health needs defined as illnesses 
and injuries that meet the following criteria: (1) Are serious or have 
moderate adverse impact on health, but affect many individuals; (2) 
could be cured, significantly improved, or prevented by the development 
or redesign of a device; and (3) the device(s) is not being developed 
or redesigned due to barriers that the Federal Government can directly 
or indirectly remove or minimize, where those barriers are out of 
proportion to what is warranted based on the public health needs.
    Medical device development and/or redesign is responsible for 
significant public health benefits, including the prevention, 
treatment, diagnosis, and monitoring of serious or life-threatening 
diseases and improved quality of life. However, unnecessary barriers to 
market may exist either due to market failures or regulatory 
inefficiencies. For example, payment practices can affect financial 
incentives for manufacturers to develop a new or improved technology. A 
predictable and consistent regulatory pathway can encourage would-be 
innovators to invest in the development of an innovative device.
    As part of this initiative, CDRH established a Council on Medical 
Device Innovation composed of participants from federal agencies. 
Agencies represented include the National Institutes of Health, the 
Centers for Disease Control and Prevention, the Centers for Medicare 
and Medicaid Services, the Agency for Healthcare Research and Quality, 
the Department of Defense, the Defense Advanced Research Projects 
Agency, and the Department of Veterans Affairs. The purpose of the 
Council is to identify the most important unmet public health needs, 
the barriers to innovative medical device development or redesign that 
could address those needs, and actions the Federal Government can

[[Page 29561]]

take to reduce those barriers while assuring the safety, effectiveness, 
and quality of medical devices marketed in the United States.
    The Council seeks input from a wide range of constituencies to 
include but not be limited to industry, academia, patient/consumer 
advocacy groups, professional organizations, and other State and 
Federal bodies under aligned public health missions, to address the 
issues outlined in this document.
    During the public workshop, there will be an open dialogue between 
Federal Government Council members and experts from the private and 
public sectors regarding the topics described in this document. 
Workshop participants will not be expected to develop consensus 
recommendations, but rather to provide their perspectives on priority 
areas in which medical device innovations can have the highest positive 
impact on public health. Participants will also be encouraged to 
comment on devices not being developed or redesigned due to barriers 
that the Federal Government can and should directly or indirectly 
remove or minimize.
    Additional information on the public workshop, including an agenda, 
will be made available in advance of June 24, 2010, at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm 
(select the appropriate meeting from the list).

II. Public Participation

    If you wish to make an oral presentation during the public 
workshop, you must indicate this at the time of registration. There are 
two types of opportunities for participation planned for the public 
workshop. In one, formal presentations will address one of the two 
topics (see section III of this document) that will be limited to 15 
minutes and require submission of the presentation in advance of the 
meeting. The other will be time-limited, based on the number of 
requests, as part of the public comment period. When registering, you 
will be required to identify the title of the topic you wish to address 
in your presentation and answer all the related questions on the web 
registration form. FDA will do its best to accommodate requests to 
present and will focus discussions to the topics described in this 
document (see section III of this document). Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their presentations, and to request time for joint 
presentations. FDA will determine the amount of time allotted to each 
presenter and the approximate time that each oral presentation is to 
begin.

III. Issues for Discussion

    The workshop will focus on three topics: (1) Identification of the 
most important unmet public health needs; (2) delineation of the 
barriers to the development, redesign, and patient and healthcare 
professional access to medical devices that can cure, significantly 
improve, or prevent these illnesses or injuries; and (3) identification 
of the actions the Federal Government can take to remove or minimize 
these barriers. The discussion of these general topics should not be 
limited by current statutes or regulations and will include, but not be 
limited to, discussion of the following questions:
    1. Identifying areas of public health need:
    a. Which unmet public health needs could be most effectively 
addressed by the development of new, or the redesign of existing, 
medical devices?
    b. How should the Council set priorities amongst the identified 
public health needs? Are there specific factors that should be 
considered? If so, which and why?
    2. Addressing barriers to development and/or redesign of medical 
devices:
    a. What are the significant barriers facing innovators, academics, 
and/or industry that limit the availability and clinical use of medical 
devices that have the potential to improve public health?
    b. How should any perceived or actual barriers be evaluated to 
determine whether federal intervention is appropriate?
    c. How should federal agencies--including those present and others 
not represented--address those barriers that are out of proportion to 
what is warranted based on the public health needs?

IV. Transcripts

    Please be advised that as soon as a transcript is available, it can 
be obtained in either 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. A transcript of the public workshop will be 
available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate 
meeting from the list).

    Dated: May 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12588 Filed 5-25-10; 8:45 am]
BILLING CODE 4160-01-S