
[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26769-26770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Educational Forum on Medical Device Reporting, Complaint Files, 
and Recalls, Corrections, and Removals; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Office of Regulatory 
Affairs (ORA), Southwest Region (SWR), Dallas District Office (DALDO), 
in collaboration with the FDA Medical Device Industry Coalition 
(FMDIC), is announcing a public workshop entitled ``Educational Forum 
on Medical Device Reporting, Complaint Files, and Recalls, Corrections, 
and Removals.'' The purpose of the public workshop is to provide 
information about FDA's Medical Device Quality Systems Regulation (QSR) 
to the regulated industry, particularly small businesses.

DATES:  Date and Time: The public workshop will be held on June 15, 
2012, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Renaissance 
Dallas Hotel, 2222 Stemmons Freeway, Dallas, TX 75207. Directions and 
lodging information are available at the FMDIC Web site at http://www.fmdic.org/.
    Contact Person: David Arvelo, Food and Drug Administration, 4040 
North Central Expressway, Suite 900, Dallas, TX 75204, 214-253-4952, 
FAX: 214-253-4970, email david.arvelo@fda.hhs.gov.
    Registration: FMDIC has a $250 early registration fee. Discounts 
for full-time students and government employees with valid 
identification are available. Early registration ends June 1, 2012. 
Registration is $300 thereafter. For more information on fees and/or to 
register online, please visit http://www.fmdic.org/. As an alternative, 
you may send registration information including name, title, firm name, 
address, telephone and fax numbers, and email, along with a check or 
money order for the appropriate amount payable to the FMDIC, to FMDIC 
Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX 
75205.

[[Page 26770]]

Registration on site 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 the FMDIC. The registration fee will be used to offset 
expenses of hosting the event including continental breakfast, lunch, 
refreshments, venue, materials, audiovisual equipment, and other 
logistics associated with this event.
    If you need special accommodations due to a disability, please 
contact David Arvelo (see Contact Person) at least 21 days in advance.

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 (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 is also consistent 
with the purposes of FDA's Regional Small Business Program, which are 
in part to respond to industry inquiries, develop educational 
materials, sponsor workshops and conferences to provide firms, 
particularly small businesses, with firsthand working knowledge of 
FDA's requirements and compliance policies. 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 workshop is to present information that will enable 
manufacturers and regulated industry to better comply with the Medical 
Device QSR. The following topics will be discussed at the workshop: (1) 
The role of complaint files, (2) medical device reporting, (3) medical 
device recalls, corrections, and removals, and (4) Corrective and 
Preventive Actions as They Relate to Complaints.
    Transcripts: Transcripts of this event will not be available due to 
the format of this workshop. Handouts will be posted online at http://www.fmdic.org/ or may be requested in writing from David Arvelo (see 
Contact Person), after the public workshop.

    Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10893 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P


