2010-6865. Food and Drug Administration/Xavier University Global Medical Device Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

SUMMARY:

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University Global Medical Device Conference.” This 3-day public conference includes presentations from key FDA officials, global regulators, and industry experts. The public conference has three separate tracks of interest for quality, regulatory affairs, and clinical research professionals, and is intended for companies of all sizes and employees at all levels.

Dates and Times: The public conference will be held on May 5, 2010, from 8 a.m. to 5 p.m.; May 6, 2010, from 8 a.m. to 5 p.m.; and May 7, 2010, from 8 a.m. to 1 p.m.

Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 513-745-3396.

Contact Persons:

For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext 167, FAX: [phone], e-mail: [e-mail].

For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: [e-mail].

Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 3 days of the conference. Early registration ends April 5, 2010. Standard registration ends May 4, 2010. There will be onsite registration. The cost of registration is as follows:

Table 1.—Registration Fees¹

Attendee	Fee by April 5th	Fee by May 4th
Industry	$995	$1,200
Small Business (<100 employees)	$800	$1,000
Academic	$600	$700
Student	$200	$250
FDA Employee	Fee Waived	Fee Waived
1 The fourth registration from the same company is free.

The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.

To register online for the public conference, please visit the “Registration” link on the conference Web site at http://www.XavierMedCon.com. 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.

To register by mail, please send your name, title, firm name, address, telephone and fax numbers, e-mail, and payment information for the fee to Xavier University, Attention: Sue Bensman, 3800 Victory Parkway, Cincinnati, OH 45207. An e-mail will be sent confirming your registration.

Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati, OH, 45202, 513-421-9100. To make reservations online, please visit the “Venue/Logistics” link at http://www.XavierMedCon.com to make reservations.

If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference.

SUPPLEMENTARY INFORMATION:

The public conference helps fulfill the Department of Health and Human Services and FDA's important mission to protect the public health. The conference will provide those engaged in FDA-regulated medical devices (for humans) with information on the following topics:

• Global compliance,
• Global approval process,
• Global harmonization,
• Recalls and corrections and removals,
• Common 483 observations,
• What happens after an inspection,
• Medical device reports,
• Regulatory impact of design and process changes,
• Integrating internal and external resources for clinical trials,
• New ways of doing biostatistics,
• Innovative clinical study design,
• Challenges in conducting global clinical trials,
• Comparison of design history file and dechnical dossier,
• Integrating risk management in device/combination products,
• Design controls: Human factors,
• Labeling and promotion,
• Corrective and preventive actions,
• International filing requirements,
• Promotion of device prior to approval,
• Combination product filings—tips for successful application,
• The role of information technology in clinical trials and post-approval process,
• Bioresearch monitoring early intervention initiatives for electronic records, and
• Handling images and other non-traditional electronic data.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) by providing outreach activities by Government agencies to small businesses.

Dated: March 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.