Food and Drug Administration/Xavier Medical Device Conference
Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016)
Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)
Notices
Page 4915
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-01681
Page 4915
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-N-0001
Food and Drug Administration/Xavier 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 co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier Medical Device Conference (MedCon).'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.
DATES: The public conference will be held on May 4, 2016, from 8:30 a.m. to 5 p.m.; May 5, 2016, from 8:30 a.m. to 5 p.m.; and May 6, 2016, from 8:30 a.m. to 12:05 p.m.
ADDRESSES: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3016.
FOR FURTHER INFORMATION CONTACT: 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: Mason Rick, Program Manager, Xavier Health, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 513-745-
3016, email: rickm@xavier.edu or visit http://www.XavierMedCon.com.
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:
Update from FDA's Office of Combination Products
Center Director Corner: Strategic Priorities for 2016 and Beyond
Office of Compliance Strategic Priorities
Medical Device Innovation Consortium (MDIC)/Xavier University Medical Device Metrics Initiative
Critical Thinking--Responding to FDA
Working Through Challenges with Supplier Quality and Design--
What to Do and When
FDA Inspections and Insights
Canada's Changing Quality System Requirements
European Medical Device Regulation Progress
Update from the Office of Device Evaluation
What to Expect with FDA's Program Alignment
When to File a 510(k) for Modifications to Your Cleared Device
Storing Clinical Data in the Cloud
Regulatory Strategy for Innovation
Internet and Social Media Concerns--FDA and Federal Trade Commission (FTC) Perspectives
Navigating Japan's Regulatory Environment
Action Plan Writing
Lunch Networking by Topic
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.
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 rates end February 3, 2016. Advance registration rates end on March 3, 2016. Standard registration rates begin March 4, 2016. There will be onsite registration. The cost of registration is as follows:
Table 1--Registration Fees \1\
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Early rate Advance rate (2/ Standard rate
Attendee type (through 2/3/16) 4/16-3/3/16) (after 3/3/16)
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Industry.................................................. $1,195 $1,495 $1,695
Small Business (
