[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Notices]
[Pages 9342-9343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


The Essentials of Food and Drug Administration Medical Device 
Regulations: A Primer for Manufacturers and Suppliers; Public Seminar

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public seminar.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Devices 
and Radiological Health and Office of Regulatory Affairs, in 
cooperation with AdvaMed's Medical Technology Learning Institute, is 
announcing a series of three seminars on FDA medical device 
regulations.
    These 2-day seminars, which are designed to address the training 
needs of start up and small device manufacturers and their suppliers, 
will include both industry and FDA perspectives and a question and 
answer period.
    Dates: The seminars are planned for the following dates:
    1. March 15 and 16, 2007, in Irvine, CA 92614. Details about dates 
are posted on AdvaMed's Web site at: www.advamed.org/irvine.\1\
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    \1\ FDA has verified the Web site addresses, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.
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    2. May 22 and 23, 2007, in Lakewood, CO 80228. Details about dates 
are posted on AdvaMed's Web site at: www.advamed.org/denver.
    3. June 6 and 7, 2007, in Pittsburgh, PA, Details about dates are 
posted on AdvaMed's Web site at: www.advamed.org/pittsburgh.
    Locations: The seminars are planned for the following locations:
    1. March 15 and 16, 2007, Crown Plaza Hotel, 17941 Von Karman, 
Irvine, CA 92614. Details about location sites are posted on AdvaMed's 
Web site at: www.advamed.org/irvine.
    2. May 22 and 23, 2007, Sheraton Denver West, 360 Union Blvd., 
Lakewood, CO 80228. Details about location sites are posted on 
AdvaMed's Web site at: www.advamed.org/denver.
    3. June 6 and 7, 2007, Hilton Pittsburgh, 600 Commonwealth Pl., 
Pittsburgh, PA 15222, www.HiltonPittsburgh.com. Details about location 
sites are posted on AdvaMed's Web site at: www.advamed.org/pittsburgh.
    Contact: For FDA: William Sutton, Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, 
800-638-2041, ext. 125, FAX: 240-276-3151, e-mail: 
[email protected].
    For AdvaMed: Dia Black, 202-434-7231, FAX: 202-783-8750, e-mail: 
[email protected].
    Registration: The registration fee for FDA employees is waived. 
Send registration information (including name, title, firm name, 
address, telephone, and fax number) and the registration fee of $495 
per person to AdvaMed contact Dia Black, 202-434-7231, FAX: 202-783-
8750. Payment forms accepted are major credit card (MasterCard, Visa, 
or American Express) or company check. If you wish to pay by check, 
contact Dia Black at: [email protected].
    To register via the Internet, go to www.AdvaMed.org. The latest 
information on dates/venue sites will be posted on this Web site at: 
www.advamed.org/irvine, www.advamed.org/denver, and www.advamed.org/pittsburgh (FDA has verified the Web site addresses, but is not 
responsible for changes to the Web sites after this document publishes 
in the Federal Register).
    For more information on the meeting, or for questions on 
registration, contact Dia Black (see Contact).
    Attendees are responsible for their own accommodations. For further 
hotel information and driving directions, go to the registration Web 
site.
    The registration fee will be used to offset the expenses of hosting 
the conference, including meals (breakfasts and a lunch), refreshments, 
meeting rooms, and training materials. It also includes a networking 
reception on the evening of the first day of each seminar.
    Space is limited; therefore, interested parties are encouraged to 
register early. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Dia Black (see Contact) at AdvaMed at least 7 days in advance 
of the seminar.

SUPPLEMENTARY INFORMATION: The ``Essentials of FDA Medical Device 
Regulations: A Primer for Manufacturers and Suppliers'' seminar helps 
fulfill the Department of Health and Human Services' and FDA's 
important mission to protect the public health by educating new 
entrepreneurs on the essentials of FDA device regulations. FDA has made 
education of the medical device community a high priority to assure the 
quality of products reaching the marketplace and to increase the rate 
of voluntary industry compliance with regulations.

[[Page 9343]]

    The seminar helps to implement the objectives of section 903 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan 
for Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The seminar also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed at small 
businesses.
    The following topics, as well as others, will be discussed at the 
seminar:
     Doing business in a regulated industry;
     Organizational structure of FDA;
     Overview of the quality system regulation;
     Design controls;
     Documents, records, and change control;
     Purchasing controls and acceptance activities;
     Production and process control;
     Corrective and preventive actions;
     Complaints, medical device reports, corrections, and 
recalls;
     Compliance issues;
     Management responsibility;
     Interacting with FDA--Where do you go for assistance?
     General question and answer session;
     Manufacturers and suppliers--the chain regulatory 
responsibility;
     Reimbursement of medical technology;
     The AdvaMed code of ethics; and
     Fraud and abuse.

    Dated: February 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3619 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S