[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Pages 30099-30100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14907]



Food and Drug Administration

[Docket No. FDA-2009-N-0664]

The Essentials of Medical Device Regulations: A Primer for 
Manufacturers and Importers; Public Seminar

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public seminar.


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 public seminars on FDA medical device 
    These 2-day public seminars, which are designed to address the 
training needs of startup and small device manufacturers and their 
suppliers, will include both industry and FDA perspectives and a 
question and answer period.

DATES: For the dates of the public seminars, see table 1 in the 
SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: For the locations of the public seminars, see table 1 in the 
SUPPLEMENTARY INFORMATION section of this document.

For FDA:
    William Sutton, Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, 10903 
New Hampshire Ave., W066-4626, Silver Spring, MD 20993-0002, 301-796-
5849, FAX: 301-847-8149, e-mail: [email protected].
For AdvaMed:
    For hotel and general information: Veronica Allen, 202-434-7231, 
[email protected].
    For registration information: Katia Kunze, 202-434-7237, FAX: 202-
783-8750, [email protected]


I. Background

    The ``Essentials of Medical Device Regulations: A Primer for 
Manufacturers and Importers'' 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.
    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 
    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 
    The following topics, as well as others, will be discussed at the 
     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 
     Compliance issues;
     Management responsibility;
     Interacting with FDA--Where do you go for assistance?
     General question and answer session;
     Manufacturers and suppliers--The chain regulatory 
     Reimbursement of medical technology;
     The AdvaMed code of ethics; and
     Fraud and abuse.

II. Public Seminar Locations and Dates

    The locations and dates for the public seminars are listed in table 
1 of this document.

[[Page 30100]]

                  Table 1.--Seminar Locations and Dates
            Seminar Location                           Date
Coronado Island Marriott Resort and      July 14 and 15, 2009
 Spa, 2000 Second St., Coronado, CA
 92118. Details are posted on AdvaMed's
 Web site at www.advamedmtli.org/san_diego diego\1\
Gaylord Opryland Resort, 2802 Opryland   August 4 and 5, 2009
 Dr., Nashville, TN 37214. Details are
 posted on AdvaMed's Web site at
San Juan Marriott Resort and Stellaris   August 12 and 13, 2009
 Casino, 1309 Ashford Ave., San Juan,
 PR 00907. Details are posted on
 AdvaMed's Web site at
\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.

III. Registration

    The registration fee is $650 per person per seminar. 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.
    To register and pay by personal check: Send your registration 
information (including name, title, firm name, address, telephone, and 
fax number) to Katia Kunze, AdvaMed, 202-434-7237, FAX: 202-783-8750, 
or email [email protected]. Katia Kunze will then provide you with 
information on how to pay your registration fee by check.
    To register and pay via the Internet: Visit the designated Web site 
for the seminar that you plan to attend (see table 1 of this document). 
Payment forms accepted are major credit card (MasterCard, Visa, or 
American Express).
    Space is limited; therefore, interested parties are encouraged to 
register early. If you need special accommodations due to a disability, 
please contact Veronica Allen (see For Further Information Contact) at 
AdvaMed at least 7 days in advance of the seminar.
    Attendees are responsible for their own accommodations. For hotel 
information and meeting locations, see table 1 of this document. There 
are a limited number of hotel rooms blocked for the seminars. Please be 
advised that the seminar room blocks close 1 month before the beginning 
of the seminar. Interested parties are encouraged to make hotel 
reservations early, as the seminar room block will fill up quickly.

    Dated: June 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14907 Filed 6-23-09; 8:45 am]