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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 [...]
Compliance with the FDA Quality System Regulation (QSR / 21 CFR Part 820) is critical for medical device manufacturers to ensure product safety, effectiveness, and regulatory adherence. The QSR outlines requirements for a Quality Management System (QMS), covering design controls, production, process validation, and corrective actions. At XPRO AMERICA, we [...]
Premarket Approval (PMA) is the FDA’s regulatory pathway for high-risk Class III medical devices, which require extensive scientific evidence demonstrating safety and effectiveness before marketing in the United States. Unlike 510(k) or De Novo submissions, PMA applications often involve clinical study data and rigorous review processes. At XPRO AMERICA, we [...]
FDA compliance does not end after a product receives clearance or approval. Companies must actively manage post-market surveillance to ensure ongoing safety, effectiveness, and regulatory compliance. Failure to meet post-market obligations can lead to recalls, penalties, import alerts, and reputational damage. At XPRO AMERICA, we provide comprehensive post-market surveillance and [...]
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 [...]
Accurate and compliant device labeling is critical to ensure safety, regulatory adherence, and market access in the United States. Under 21 CFR Part 801, the FDA requires medical devices to have labels that clearly communicate intended use, instructions, and risk information. Compliance with Unique Device Identification (UDI) regulations further enhances [...]
An Investigational Device Exemption (IDE) allows medical device manufacturers to conduct clinical trials in the United States using investigational devices that have not yet received FDA clearance or approval. IDE submissions enable the collection of safety and effectiveness data essential for regulatory pathways such as 510(k), De Novo, or PMA. [...]
Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical devices entering the U.S., including establishment registration, device listing, labeling, and prior notice requirements. At XPRO AMERICA, we provide comprehensive [...]
For companies that manufacture, package, or distribute FDA-regulated products, inspection and audit readiness is critical to maintaining compliance and avoiding enforcement actions. The FDA routinely conducts inspections, including at foreign facilities exporting to the U.S., to ensure adherence to regulatory standards. Lack of preparedness can result in Warning Letters, Import [...]
The FDA requires electronic submissions for medical device applications, including 510(k), De Novo, and PMA pathways. Two primary formats are used: eCopy and eSTAR (Electronic Submission Template And Resource). Correct formatting and submission are critical to avoid review delays and ensure regulatory compliance. At XPRO AMERICA, we provide full-service support [...]