06-5570. 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.

SUMMARY:

The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 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 July 12, 2006, from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at The Marriott Fremont, 46100 Landing Pkwy., Fremont, CA 94538, 510-413-3710, FAX: [phone]. For further hotel information and driving directions, go to http://Marriott.com/​property/​propertypage/​sjcfm. (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: Eric Anderson, Office of Regulatory Affairs (HFR-PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 95115, 408-291-7548, ext. 115, FAX: [phone], e-mail: [e-mail].

For AdvaMed: Krystine McGrath, 202-434-7237, FAX: [phone], e-mail: [e-mail].

Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495.00 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.advamedmtli.org/​mtli/​fda.cfm. (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.)

Payment forms accepted are major credit cards (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 (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 lunches), refreshments, meeting rooms, and training materials. It also includes a networking reception on July 12, 2006. 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 Eric Anderson (see Contact) 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 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:

• Doing business in a regulated industry;
• Organizational structure of FDA;
• The quality system regulations and inspections;
• Design controls;
• Compliance issues;
• Management responsibility;
• Interacting with FDA—where do you go for assistance;
• Manufacturers and suppliers—the chain of regulatory responsibility;
• Reimbursement and medical technology;
• The AdvaMed code of ethics;
• Fraud and abuse;
• Human factors;
• Documents, records and change controls;
• Purchasing controls and acceptance activities;
• Production and process control;
• Corrective and preventive actions;
• Complaint handling, medical device reporting, and servicing; and
• Training and audits;

Transcripts: There will be no transcripts for this public workshop.

Dated: June 16, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.