FDA & Regulatory
Technology and Regulatory Affairs Department
AdvaMed's Technology and Regulatory Affairs (T&R) department works to ensure that patients have timely access to needed medical technologies. Our goal is to ensure that regulatory processes, especially those involving the Food and Drug Administration (FDA), are reasonable and predictable and result in science-based decisions. We work with members to develop pre-market approval policies that speed patient access to new technologies, ensure reasonable post-market and inspection programs, develop a legislative agenda, and to coordinate on international regulatory efforts.
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