[Federal Register Volume 70, Number 193 (Thursday, October 6, 2005)]
[Notices]
[Pages 58446-58447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20093]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Philadelphia District, 
in cooperation with AdvaMed's Medical Technology Learning Institute, is 
announcing a public workshop on FDA device regulations. This 1 1/2-day 
public workshop for start up and small device manufacturers and their 
suppliers will include both industry and FDA perspectives and a 
question and answer period.
    Date and Time: The public workshop will be held on Tuesday, October 
11, 2005, from 8:30 a.m. to 5:30 p.m. and Wednesday, October 12, 2005, 
from 8:30 a.m. to 12 noon.
    Location: The public workshop will be held at The Wyndham 
Philadelphia at Franklin Plaza, 17th and Race St., Philadelphia, PA 
19103, 215-448-2000. For further hotel information and driving 
directions, go to http://www.wyndham.com/hotels/PHLFP. (FDA has 
verified the Web site address, but is not responsible for subsequent 
changes to the Web site after this document publishes in the Federal 
Register.)
    Contact:
    For FDA: Judy Summers-Gates, Food and Drug Administration, rm. 900, 
U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-717-
3008, FAX: 215-597-4660, e-mail: <a href="/cdn-cgi/l/email-protection#e68c93828f928ec895938b8b839495cb8187928395a6808287c8818990"><span class="__cf_email__" data-cfemail="c0aab5a4a9b4a8eeb3b5adada5b2b3eda7a1b4a5b380a6a4a1eea7afb6">[email protected]</span></a>.
    For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-783-8750, 
<a href="/cdn-cgi/l/email-protection#503b3d33372231243810313426313d35347e3f2237"><span class="__cf_email__" data-cfemail="214a4c42465340554961404557404c44450f4e5346">[email protected]</span></a>; or Dia Black, 202-434-7231, FAX: 202-783-8750, e-
mail: <a href="/cdn-cgi/l/email-protection#8de9efe1eceee6cdecfbece0e8e9a3e2ffea"><span class="__cf_email__" data-cfemail="a4c0c6c8c5c7cfe4c5d2c5c9c1c08acbd6c3">[email protected]</span></a>.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), and the registration 
fee of $350 per person to the AdvaMed contacts (see Contact). The 
registration fee for FDA employees is waived. To register via the 
Internet go to http://www.advamed.org/philadelphia. (FDA has verified 
the Web site address, but is not responsible for subsequent changes to 
the Web site after this document publishes in the Federal Register.)

[[Page 58447]]

    Payment forms accepted are major credit card (MasterCard, Visa, or 
American Express) or company check. If you wish to pay by check contact 
Krystine McGrath (see Contact). For more information on the meeting, or 
for questions on registration, contact Krystine McGrath or Dia Black 
(see Contact). Attendees are responsible for their own accommodations.
    The registration fee will be used to offset the expenses of hosting 
the workshop, including meals (breakfasts and a lunch), refreshments, 
meeting rooms, and training materials. It also includes a networking 
reception on Tuesday, October 11, 2005. 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 Judy Summers-Gates at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The ``Essentials of FDA Device Regulations: 
A Primer for Manufacturers and Suppliers'' workshop 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 workshop 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 workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by government agencies directed to small 
businesses.
    The following topics will be discussed at the workshop:
    <bullet> Doing business in a regulated industry;
    <bullet> Organizational structure of FDA;
    <bullet> The quality system regulations and inspections;
    <bullet> Complaints, medical device reporting, corrections, and 
recalls;
    <bullet> Compliance issues;
    <bullet> Management responsibility;
    <bullet> Interacting with FDA--where do you go for assistance?;
    <bullet> General question and answer session;
    <bullet> Manufacturers and suppliers--the chain of regulatory 
responsibility;
    <bullet> Reimbursement and medical rechnology;
    <bullet> The AdvaMed code of ethics; and
    <bullet> Fraud and abuse.

    Dated: September 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20093 Filed 10-5-05; 8:45 am]
BILLING CODE 4160-01-S


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