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The U.S. FDA provides multiple 510(k) pathways to streamline medical device clearance, including the Special 510(k) and Abbreviated 510(k) routes. Selecting the correct pathway is essential for efficient review, regulatory compliance, and avoiding unnecessary delays or additional testing. At XPRO AMERICA, we specialize in guiding manufacturers through these specialized pathways, [...]
Accurate and FDA-compliant labeling is essential for the safe use, marketing, and distribution of medical devices in the United States. Under 21 CFR Part 801, the FDA sets strict requirements for device labels and Instructions for Use (IFU), ensuring that healthcare providers and patients clearly understand product applications, limitations, and [...]
After obtaining 510(k) clearance, medical device manufacturers must maintain strict compliance with the FDA Quality System Regulation (QSR, 21 CFR Part 820). FDA inspections can occur at any time and focus on ensuring that your quality management system, production processes, and corrective actions meet regulatory requirements. Being unprepared can result [...]
Successful FDA 510(k) submissions require not only a complete dossier but also effective communication with the FDA throughout the review process. Misunderstandings, incomplete responses, or delays in addressing Additional Information (AI) requests can prolong approval timelines and create regulatory risk. At XPRO AMERICA, we provide end-to-end support for FDA communication [...]
After successfully navigating the 510(k) or De Novo submission process, medical device manufacturers must secure their FDA clearance certificate and ensure ongoing compliance with post-market requirements. Timely clearance and accurate post-market setup are essential for legal distribution and long-term regulatory success in the U.S. market. At XPRO AMERICA, we provide [...]
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 [...]
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 [...]
The FDA regulates color additives and food contact substances (FCS) to ensure safety for consumers. Companies introducing new color additives or materials intended for contact with food must comply with rigorous FDA requirements, including premarket approval, notifications, and safety testing. At XPRO AMERICA, we provide end-to-end guidance for manufacturers, distributors, [...]
Foreign companies manufacturing, repackaging, relabeling, or importing FDA-regulated products into the United States are required to appoint a U.S. Agent. The U.S. Agent serves as the official liaison between the company and the FDA, ensuring that regulatory communications, inspection notices, and emergency matters are handled efficiently and accurately. At XPRO [...]