OBJECTIVES: Upon completion of this activity, the participant should be able to:

1.  Recognize the federal regulatory process to design trials for innovative novel devices.

2.  Identify the reasons companies select clinical sites to conduct these trials.

FACULTY DISCLOSURE:  J. Michael DiMaio, MD has no relevant financial relationship(s) with companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

PLANNER DISCLOSURE:  Dr. Michael Mack, MD; Jennifer Thomas, BS, MS;  Alaina Tellson PhD, RN, NPD-BC, NE-BC; and Crystal Brooks, LMSW, ACM-SW, CTP , have no relevant financial relationship(s) to disclose with companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

ACCREDITATION: The A. Webb Roberts Center for Continuing Medical Education of Baylor Scott & White Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION:  The A. Webb Roberts Center for Continuing Medical Education of Baylor Scott & White Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

SOCIAL WORKERS: This program meets the qualifying criteria for social work continuing education pursuant to TAC 781.509 and is directly related to the practice of social work and is approved for 1.0 CEU- BSWH SW CE Approval 369235.