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Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
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Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Details of the PCCP will be publicly available (i.e., PMA summary of safety and effectiveness document (SEED) and approval order, 510(k) Summary, De Novo decision summary).
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