Food and Drug Administration/Xavier University Global Medical Device Conference

SUMMARY: The Food and Drug Administration(FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled "FDA/Xavier University Global Medical Device Conference (MedCon)." This 3-day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels.

.... Table 1--Registration Fees..*1

Attendee Type.................................. Early.... Advanced..Standard

................................................rate......rate......rate

................................................(through..(3/12/14..(4/9/14

................................................3/11/14)..to........to

..........................................................4/8/14).. 5/9/14)

Industry........................................ $1,195....$1,495....$1,695

Small Business (<100 employees)..................$900......$1,000....$1,200

Startup Manufacturer............................ $200......$250......$300

Academic........................................ $200......$250......$300

FDA/Government Employee........................ Fee...... Fee...... Fee

................................................Waived....Waived....Waived.

....*1 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, email, and payment information for the fee to Xavier University, Attention: Mason Rick, 3800 Victory Parkway, Cincinnati, OH 45207. An email will be sent confirming your registration.

Attendees are responsible for their own accommodations. The conference headquarters hotel is the Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati, OH, 45202, 513-421-9100. Special conference block rates are available through April 16, 2014. To make reservations online, please visit the "Venue/Logistics" link at http://www.XavierMedCon.com.

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:

* Center for Devices and Radiological Health Future Vision and Strategy Keynote Address;

* European Union Regulations: New Regulations, Company Strategy, and Open Discussion Forum;

* How to Implement the Unique Device Identification Requirements;

* Update from the Office of Device Evaluation;

* FDA Regulation of Health Information Technology: Medical Apps, Cybersecurity, and "the Cloud";

* Managing Scientific and Regulatory Disagreement;

* Combination Products;

* FDA Inspectional Approach--Panel with current FDA investigators;

* Operationalizing Post-Market Surveillance;

* 510(k) Process;

* Risk Management;

* Purchasing Controls;

* Office of Compliance Update; and

* Strategic Thinking on Access in China.

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 (Pub. L. 104-121) by providing outreach activities by Government Agencies to small businesses.

Dated: February 20, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

Notice of public conference.

Citation: "79 FR 10815"

Document Number: "Docket No. FDA-2014-N-0001"

Federal Register Page Number: "10815"

"Notices"