[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Page 9469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03584]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Medical Devices--The Case for Quality
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
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The Food and Drug Administration (FDA), Office of Regulatory
Affairs, Southwest Regional Office, in cosponsorship with the FDA
Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public
workshop entitled ``Medical Devices--the Case for Quality.'' The public
workshop is intended to seek input from representatives of medical
device manufacturers and other stakeholders on best practices, what has
worked for them, and what FDA can do to inspire quality efforts. This
event will also focus on various topics of interest for those industry
representatives who are responsible to ensure compliance with FDA
regulations.
Date and Time: The meeting will be held on April 11, 2014 from 8
a.m. to 5 p.m.
Location: The meeting will be held at Wyndham Dallas Suites-Park
Central, 7800 Alpha Rd., Dallas, TX 75240. Directions and lodging
information are available at the FMDIC, Inc. Web site at http:/
www.fmdic.org/.
Contact: C. Sue Thomason, Food and Drug Administration, 4040 N.
Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5203, FAX:
214-253-5318, email: [email protected].
Registration: FMDIC has early registration (industry $250,
government with ID $150, student $50) available until March 11, 2014.
Registration after March 11, 2014, increases to industry $300,
government with ID $200, with student registration staying the same at
$50. To register online, please visit http://www.fmdic.org/. As an
alternative, send registration information including the registrant's
name, title, organization, address, telephone and fax numbers, and
email address (for each registrant), along with a check or money order
(covering all registration fees) payable to FMDIC, Inc., to FMDIC
Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX
75205.
FMDIC, Inc. accepts registrations onsite on the day of the event
beginning at 7:30 a.m. at the regular registration fee stated above.
Registration onsite will be accepted on a space-available basis on the
day of the public workshop beginning at 7:30 a.m. Please note that due
to popularity, similar past events have reached maximum capacity well
before the day of the event. The cost of registration at the site is
$300 payable to FMDIC, Inc. The registration fee will be used to offset
expenses of hosting the event, including continental breakfast, lunch,
audiovisual equipment, venue, materials, and other logistics associated
with this event.
If you need special accommodations due to a disability, please
contact C. Sue Thomason (see Contact) at least 7 days in advance.
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop.
SUPPLEMENTARY INFORMATION: The workshop is being held in response to
the interest in the topics discussed from small medical device
manufacturers in the Dallas District area. This workshop helps achieve
objectives set forth in section 406 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 393), which
include working closely with stakeholders and maximizing the
availability and clarity of information to stakeholders and the public.
This workshop is also consistent with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as an outreach
activity by Government agencies to small businesses.
The goal of the public workshop is to present information that will
enable manufacturers and regulated industry to better comply with FDA's
medical device requirements. Please visit the www.fmdic.org Web site
for the agenda and for information about the presenters at the
workshop.
Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03584 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P