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Regulatory Strategy Development for FDA 510(k) Submissions – XPRO AMERICA

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 [...]

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510(k) Eligibility & Device Classification Guidance – XPRO AMERICA

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 [...]

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