Compliance Program
InVivo Therapeutics has a well-established Compliance Program that reflects a strong commitment to compliance with the laws and regulations that govern the medical device and pharmaceutical development, marketing and commercialization activities in the United States. InVivo Therapeutics’ Compliance Program adheres to the requirements of the U.S. Food and Drug Administration’s “Medical Device Quality Systems Manual,”, and is consistent with, where applicable, the recommendations set forth in “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). In addition, InVivo is committed to promoting and enforcing the provisions of the “Code of Ethics on Interactions with Health Care Professionals” as adopted by the Advanced Medical Device Technology Association (AdvaMed). The goal of our Compliance Program has always been to maintain a culture that promotes the prevention, detection, and resolution of potential violations of law or Company policy and appropriate and proactive identification and management of potential hazards in the development, research and use of medical devices and their component or adjunctive therapies in human populations.
The fundamental elements of InVivo Therapeutics’ Compliance Program as it relates to development, sales and marketing activities in the United States are described below. The Compliance Program is dynamic, involving regular assessment and adjustment to ensure the Program is responsive to changes in the regulatory environment and requirements with sensitivity to the Company’s evolving business and associated compliance risks.