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RISMedical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: The FDA 510(k) clearance process is the most common regulatory pathway for medical devices. Since 2010, it has been at the forefront of regulatory policy discussion, with a multitude of stakeholders involved in a substantive ...