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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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Radiation-Emitting Product Compliance & Reporting – XPRO AMERICA

Devices that emit radiation, including X-ray machines, lasers, ultrasound equipment, tanning lamps, and microwave ovens, are regulated by the FDA under 21 CFR Parts 1000–1050. Manufacturers, importers, and distributors must comply with strict registration, reporting, and safety requirements to ensure public health and avoid regulatory enforcement actions. At XPRO AMERICA, we provide end-to-end [...]

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