Food and Drug Administration/Xavier University Global Medical Device Conference
Federal Register, Volume 79 Issue 38 (Wednesday, February 26, 2014)
Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)
Notices
Pages 10815-10816
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-04134
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-N-0001
Food and Drug Administration/Xavier University Global Medical Device Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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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.
Dates and Times: The public conference will be held on May 7, 2014, from 8:30 a.m. to 5 p.m.; May 8, 2014, from 8:30 a.m. to 5 p.m.; and May 9, 2014, from 8:30 a.m. to 12:45 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 513-745-3020.
Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, FAX: 513-679-2771, email: gina.brackett@fda.hhs.gov.
For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu.
Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. Early registration ends March 11, 2014. Advanced registration rates begin March 12, 2014. Standard registration rates begin April 9, 2014. There will be onsite registration. The cost of registration is as follows:
Page 10816
Table 1--Registration Fees \1\
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Early rate (through 3/ Advanced rate (3/12/14 Standard rate (4/9/14
Attendee Type 11/14) to 4/8/14) to 5/9/14)
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Industry............................. $1,195 $1,495 $1,695
Small Business ( 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.
FR Doc. 2014-04134 Filed 2-25-14; 8:45 am
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