[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56719-56720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Challenging Regulatory and Reimbursement Paradigms for Medical 
Devices in the Treatment of Metabolic Diseases: How to Estimate and 
Reward True Patient-Centric Value in Innovation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Changing Regulatory and Reimbursement Paradigms for 
Medical Devices in the Treatment of Metabolic Diseases: How to Estimate 
and Reward True Patient-Centric Value in Innovation.'' FDA is 
cosponsoring the workshop with the American Gastroenterological 
Association (AGA). The purpose of the workshop is to facilitate 
discussion between FDA, AGA, and other interested parties of the 
development of medical devices for the treatment of morbid obesity and 
other metabolic diseases and evolving approaches for the regulation and 
reimbursement of minimally invasive procedures.
    Dates and Times: The public workshop will be held on October 17, 
2013, from 8:30 a.m. to 5 p.m. and October 18, 2013, from 8:30 a.m. to 
12:15 p.m.
    Location: The public workshop will be held at the Grand Hyatt 
Washington,

[[Page 56720]]

1000 H St. NW., Washington, DC 20001, 202-582-1234.
    Contact Person: Herbert Lerner, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. G114, Silver Spring, MD 20993-0002, 301-796-6511, email: 
herbert.lerner@fda.hhs.gov.
    Registration: Registration is limited and is available on a first-
come, first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m. (EDT), October 10, 2013. Onsite 
registration will be available after this date. To register for the 
public workshop, please visit AGA's Web site at http://www.gastro.org/education-meetings/live-meetings/aga-fda-regulation-and-reimbursement-workshop. For more information on the workshop, please visit FDA's 
Medical Devices News & Events--Workshops & Conferences calendar at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
    The AGA will collect a registration fee to cover its share of the 
expenses associated with the public workshop, which is included in the 
registration information on the AGA Web site.
    If you need special accommodations due to a disability, please 
contact Herbert Lerner (see ``Contact Person'') at least 7 days before 
the public workshop.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the public workshop is to facilitate discussion 
between FDA, the AGA and other interested parties on the issues of 
device development, public and private payer reimbursement, venture 
capital, and regulatory pathways for device innovation and marketing. 
The workshop will provide a forum for discussing new approaches for the 
treatment of morbid obesity and other metabolic diseases as well as 
evolving approaches for the regulation and reimbursement of minimally 
invasive procedures.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to:
     Challenges to MedTech Innovation in the United States;
     Evolving Approaches for the Regulation of Minimally 
Invasive Procedures: The FDA Benefit/Risk Paradigm;
     Evolving Approaches for the Reimbursement of Minimally 
Invasive Procedures: How to Put a Price on Value;
     Obesity as a Disease: Redefining the Regulatory and 
Reimbursement Context; and
     The ``Process''--Investigational Device Exemption Review.

    Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22311 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P