Description
Gaining access to the United States medical device market requires full compliance with the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 807. The FDA medical device approval process involves determining device classification, selecting the correct regulatory submission pathway, and ensuring compliance with the Quality Management System Regulation (QMSR) under 21 CFR Part 820.
SOP-REG-005: Medical Device Marketing Authorization in the United States provides a structured, step-by-step Standard Operating Procedure (SOP) for manufacturers, importers, and regulatory professionals navigating the 510(k) clearance, De Novo classification, or Premarket Approval (PMA) process. This SOP ensures full compliance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and FDA post-market requirements, allowing companies to accelerate approval timelines and maintain regulatory compliance in the U.S.
Navigating the FDA medical device approval process is complex, with strict regulatory requirements and multiple approval pathways. Without a clear regulatory strategy, companies risk delays, application rejections, and compliance penalties. SOP-REG-005: Medical Device Marketing Authorization in the United States simplifies the process by providing a structured approach to determining the correct classification, preparing and submitting 510(k), De Novo, or PMA applications, ensuring compliance with FDA Quality System Regulation (QSR) and MDSAP, and meeting post-market obligations such as Medical Device Reporting (MDR) and recalls.
This SOP is an essential tool for businesses planning to enter or expand in the U.S. medical device market. It is designed for Medical Device Manufacturers, Regulatory Affairs Professionals, Importers & Distributors, Consultants & Advisors, and Startups & SMEs needing a cost-effective and structured regulatory approach to FDA compliance.
With SOP-REG-005, your business can save time and eliminate uncertainty with a structured regulatory roadmap, prevent application rejections with accurate, complete submissions, and reduce costs and speed up approvals by leveraging international regulatory certifications. Ensuring full post-market compliance minimizes the risk of penalties and product recalls, helping your company gain U.S. market access faster with a proven step-by-step regulatory strategy.
