[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Page 69694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Changing Regulatory and Reimbursement Paradigms for Medical 
Devices in the Treatment of Obesity and 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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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Changing Regulatory and Reimbursement Paradigms for 
Medical Devices in the Treatment of Obesity and 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. The public workshop is 
being rescheduled due to the government shutdown. The title of the 
workshop has also been changed.

Dates amd Times:  The public workshop will be held on December 19, 
2013, from 8:30 a.m. to 5 p.m. and on December 20, 2013, from 8:30 a.m. 
to 12:15 p.m.
    Location: The public workshop will be held at the Grand Hyatt 
Washington, DC, 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), December 10, 2013. 
Onsite registration will be available after this date. To register for 
the public workshop, please visit the American Gastroenterological 
Association (AGA) Web site: http://www.gastro.org/education-meetings/live-meetings/aga-fda-regulation-and-reimbursement-workshop. For more 
information on the workshop, please see the 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: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27771 Filed 11-19-13; 8:45 am]
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