Faculty
Robert Klepinski, Partner, Fredrikson & Byron, P.A.
Casper E. Uldriks, Associate Director for Regulatory Guidance and Government Affairs, Office of the Center Director, CDRH, FDA

Program Description
With the Endotec case as the first custom medical device case in years, and perhaps only the second in history, what is the status of custom devices after the Endotec case?   FDA has never promulgated regulations or guidance on custom devices, and, industry needs guidance. The speakers will review the statute and interpret the Endotec case going forward. Medical device experts will also discuss:

• What is a custom device?
• Do limits exist for the number of custom devices a manufacturer can produce?
• How do custom devices contrast to other methods, such as compassionate use?

The speakers will review the statute, interpret Endotec and explore FDA's potential regulatory response.

Handouts
Slides will be made available to registrants before each webinar.

Q&A: 
Questions can be submitted during the webinar and addressed by the appropriate speaker or mailed to questions@fdli.org

Registration Fees

$ 395 Member
$ 595 Nonmember

$ 395 Government Member
$ 450 Government Nonmember        

$ 395 Academic Member
$ 450 Academic Nonmember

$ 395 Sole Practitioner Member
$ 595 Sole Practitioner Nonmember

$ 100 Student Member
$ 125 Student Nonmember

Special CD Price!
Purchase the CD set for just $75 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC and Maryland addresses will be charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420,
or by e-mail at service@fdli.org, if you have any questions about your conference registration or CD order.

ROBERT J. KLEPINSKI is an Officer with the law firm of Fredrikson & Byron, PA based in Minneapolis, MN. He practices in the Food, Drug & Medical Device Regulation, Health Care Fraud & Compliance and Intellectual Property Groups. Mr. Klepinski counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA matters. He was the regulatory attorney for Medtronic, Inc., the world’s leading medical technology company specializing in implantable and invasive therapies. Mr. Klepinski frequently speaks at both local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is currently an adjunct professor at St. Thomas University in its Graduate School of Engineering and mini MBA programs. Mr. Klepinski received his BA in mathematics and English from the University of Minnesota and his JD from William Mitchell College of Law.

CASPER E. ULDRIKS is the Associate Director for Regulatory Guidance and Government Affairs at the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH). He is recognized as FDA’s expert on several statutory provisions and regulatory programs for devices. Mr. Uldriks served for ten years as the senior special assistant to the Director of the Office of Compliance in CDRH and for five years as the Congressional Liaison in FDA’s Office of Legislative Affairs for FDA’s medical device program. He also served as a Public Health Advisor in the U.S. House of Representative’s Small Business Subcommittee on Regulation, Business Opportunity, and Technology under the LEGIS Fellows Program. Mr. Uldriks began his FDA career in 1978 as a Field Investigator in Boston, MA. He received his BA from Albion College, his MDiv from Boston University, and his JD from Suffolk University in Boston, MA.

Minimum requirements to run Conference America’s WebEcho, the service that delivers visual presentations over the web in combination with a standard conference:
Windows 98 / ME / NT / 2000 / XP
Other compatible Operating Systems:
• SPARC Solaris
• Netscape 4.7
• IRIX and HP-UX
• Netscape 4.7
• Red Hat Linux 7.3
• Netscape 4.7
• Mac OSX
• Internet Explorer 5.1
• Netscape 6.2.3

Intel x86 (Pentium 400MHZ +) or compatible processor
256 MB RAM
JavaScript and cookies enabled in the browser
Java 1.4 Plug-in (www.java.com)
56K or faster Internet connection (DSL+ Recommended)