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…
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…
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…
intaining 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…
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with…
For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead…