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When introducing a medical device into the U.S. market, one of the most critical steps is determining whether the product requires a 510(k) submission and identifying the correct FDA device classification. The U.S. Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and proper classification [...]
A 510(k) dossier is the cornerstone of the FDA premarket notification process for medical devices. To demonstrate that a device is substantially equivalent to a legally marketed predicate, manufacturers must prepare a comprehensive submission that meets all regulatory requirements. The quality and completeness of this dossier directly influence review timelines [...]
The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]