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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 [...]
Submitting medical device applications to the U.S. FDA requires not only accurate regulatory content but also the correct submission format. The FDA now strongly encourages the use of eSTAR (Electronic Submission Template And Resource) for 510(k) and De Novo submissions, while eCopy remains the standard for PMA and certain other [...]
For many medical devices, bench testing, biocompatibility studies, and performance data may be sufficient to demonstrate safety and effectiveness. However, in certain cases, the FDA requires clinical evidence to support a device’s regulatory submission. Knowing when clinical data is expected and preparing it correctly can be the difference between a [...]
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 [...]
Veterinary medical devices are regulated similarly to human medical devices, with the FDA providing guidance to ensure safety, efficacy, and regulatory compliance for animal health products. Manufacturers, importers, and distributors must comply with device registration, product listing, labeling, and safety reporting requirements to legally market veterinary devices in the United [...]
The U.S. FDA’s Center for Tobacco Products (CTP) regulates tobacco and electronic nicotine delivery systems (ENDS), including e-cigarettes. Manufacturers, importers, and distributors must comply with rigorous regulatory requirements to legally market their products in the United States. Compliance ensures both legal market access and alignment with public health objectives. At [...]