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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 [...]
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 [...]
Infant formula and baby foods are subject to strict FDA regulations to ensure safety, nutritional adequacy, and labeling accuracy for vulnerable populations. Manufacturers must comply with specialized review requirements, register facilities, and maintain adherence to nutrient content standards before marketing their products in the United States. At XPRO AMERICA, we provide comprehensive guidance [...]
Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) are highly regulated by the FDA to ensure safety, quality, and traceability. Facilities that manufacture, process, store, or distribute HCT/Ps must comply with 21 CFR Part 1271 requirements, including registration, listing, adherence to Good Tissue Practices (GTP), and inspection readiness. At XPRO AMERICA, [...]