Conference

Monday, June 2, 2008
9:00 A.M. - 4 P.M.

Session 100 - Marketing a Medical Device in the United States

Instructors: William (Bill) Sutton, DSMICA, CDRH, FDA; Marjorie Shulman, ODE, CDRH, FDA; Julie "Brandi" Stuart, Consumer Safety Officer, ODE, POS, CDRH, FDA; Michael Marcaelli, Director, CDRH, OC, DBM, FDA; and Joseph (Joe) V. Puleo, DSMICA, CDRH, FDA CDRH Regulatory Overview: William (Bill) Sutton, DSMICA, CDRH, FDA Definition of a device General and special controls Registration and listing Labeling FDA Clearance and Approval: Marjorie Shulman, ODE, CDRH, FDA and Julie "Brandi" Stuart, Consumer Safety Officer, ODE, POS, CDRH, FDA Premarket notification - 510(k) Premarket approval application (PMA) Unapproved Medical Devices: Michael Marcarelli, Michael Marcaelli, Director, CDRH, OC, DBM, FDA Investigational Device Exemption Bioresearch Monitoring Program Overview of FDA Amendments of 2007: Joseph Puleo, DSMICA CDRH, FDA Medical Device User Fees Small Business Determinations (SBDs) for Foreign Establishments Streamlines accredited persons for inspection Pediatric devices

ABOUT THE INSTRUCTORS

William (Bill) Sutton, DSMICA, CDRH, FDA

William (Bill) Sutton has been employed by the Food and Drug Administration (FDA) for over 24 years. He has been a consumer safety officer in the Center for Devices and Radiological Health's (CDRH's) industry and international assistance program since 1995 and currently serves as Deputy Director. Prior to joining the Division of Small Manufacturers, International and Consumer Assistance (DSMICA), he served 12 years in the Office of Device Evaluation. His primary duties were to perform preliminary reviews of medical device applications. He received numerous awards for is role in developing detailed databases to track investigational and premarket applications. Since 1998, Mr. Sutton has done extensive work with the International Relations Staff. This group facilitates commerce in medical devices by pursuing harmonization of regulatory requirements and by encouraging mutual recognition agreements between the U.S. and other countries. He has explained the FDA requirements for exporting and importing medical devices to industry and officials of governments including Canada, China, Malaysia, Russia, South America, Africa, as well as member states of the European Union. He is also a principal member of the Center's U.S./EC Mutual Recognition Agreement (MRA) Medical Device Annex Implementation Team.

Marjorie Shulman, ODE, CDRH, FDA

Marjorie Shulman is a consumer safety officer on the Premarket Notification Staff, Program Operations Staff, in FDA’s Office of Device Evaluation. She is also the project officer for the Center for Devices and Radiological Health’s document mail centers and mailroom as well as the classification/ reclassification coordinator for the Office of Device Evaluation. Ms. Shulman has also been involved in the implementation of MDUFMA.

Julie "Brandi" Stuart, Consumer Safety Officer, ODE, POS, CDRH, FDA

Mrs. Julie Stuart has been an employee with the Department of Health and Human Services (DHHS) since 1992. She currently serves as a Consumer Safety Officer in the Office of Device Evaluation's Premarket Notification (510(k)) Staff in the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). Since 1992 her experience in DHHS has included time in various offices and program areas throughout DHHS such as medical device premarket programs (medical device premarket submission regulations and policies, medical device classification, Good Guidance Practices, reprocessed single-use devices), medical device post-market and inspectional programs (quality system regulations, foreign and domestic inspection programs) and research and development (NIH (Pubmed)).

Michael Marcarelli, Michael Marcaelli, Director, CDRH, OC, DBM, FDA

Michael Marcarelli serves as Director of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health. He has over 20 years of FDA regulatory experience in the field and in Headquarters. Prior to his work at FDA, Michael served as an investigator with the Drug Enforcement Administration and as a clinical pharmacist with the Veterans Administration.

Michael received his undergraduate degree from Northeastern University in Boston and his doctorate from the University of Arkansas in Little Rock. He recently received a MS Regulatory Affairs degree from Johs Nopkins University, Baltimore, MD.

Joseph Puleo, DSMICA CDRH, FDA

Joseph (Joe) V. Puleo is the Chief of the Technical Assistance Branch, Division of Small Manufacturers, International and Consumer Assistance (DSMICA), U.S. Food and Drug Administration (FDA), Rockville, Maryland. He joined the DSMICA staff in 1990 after 18 years in FDA's Brooklyn complex as an FDA investigator and on the staff of the Regional FDA Director. He has inspected a wide variety of medical device, in vitro diagnostic and pharmaceutical manufacturers, reprocessors, and distributors. Mr. Puleo has a wealth of experience in providing training and assistance to federal, state, and local health, agriculture, and consumer protection departments; professional associations, and trade organizations. He has conducted workshops throughout the Northeast Region, Puerto Rico, and the U.S. Virgin Island, while based in New York. Since coming to DSMICA, he has made presentations throughout the United States, Canada, Mexico, and Europe. Mr. Puleo now specializes in the medical device good manufacturing practices, process validation, environmental controls, and quality systems for medical devices. He has assisted in the revision of the Quality System (GMP) Manual and many of the DSMA workshops. He served as president of the New York Conference of CASA (Central Atlantic States Association of Food and Drug Officials.), and committee member on several professional associations. Mr. Puleo has written articles on a variety of environmental health and regulatory issues.