At Spectranectics, we are committed to doing business with compliance at the forefront. Our dedicated Compliance department is responsible for overseeing many of the operations at the Company. The Department provides insight into everything from promotional and product activities to manufacturing regulations. Our Chief Compliance Officer reports directly to the CEO and communicates directly with the Board of Directors Compliance Committee Chairman on all compliance activities.
Federal and State Disclosure Requirements
Spectranetics closely monitors evolving federal and state laws and regulations governing disclosure requirements surrounding our relationships with health care professionals.
1. California Annual Declaration of Compliance
As part of Spectranetics´ continuing commitment to corporate compliance, Spectranetics declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Spectranetics believes it is in compliance with its Commercial and Development Comprehensive Compliance Program in all material respects.
Consistent with Spectranetics´ understanding of the California statute, this declaration is limited to those activities undertaken by Spectranetics that are directed to California. Spectranetics makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the May 2003 Compliance Program Guidance for Pharmaceutical Manufacturers issued by the United States Department of Health and Human Services Office of Inspector General. This Guidance advances the seven elements of an effective compliance program, now widely recognized throughout the industry, however affords broad discretion to manufacturers in the definition of scope as well as development and design of manufacturer administered compliance programs.
To report compliance concern please call (877) 792-6460 or email Spectranetics.