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Developing the right regulatory strategy is one of the most critical steps in successfully bringing a medical device to the U.S. market. The U.S. Food and Drug Administration (FDA) requires medical devices to follow specific premarket pathways, and choosing the correct route can save time, reduce costs, and improve approval [...]
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 [...]
Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations ensures patient safety, reduces liability, and supports timely FDA oversight. At XPRO AMERICA, we provide end-to-end support for implementing a [...]
Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based on risk level, intended use, and regulatory controls. Choosing the correct submission route 510(k), De Novo, or PMA (Premarket Approval)—is [...]
The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain FDA marketing authorization by demonstrating safety and effectiveness while establishing a new device classification. At XPRO AMERICA, we provide expert [...]