In the highly regulated U.S. market, product recalls and enforcement actions can significantly impact a company’s reputation, finances, and consumer trust. Whether involving food, dietary supplements, cosmetics, or medical devices,…
Achieving U.S. FDA compliance is only the first step maintaining it requires constant attention. FDA regulations are dynamic, with frequent updates to labeling rules, safety standards, registration requirements, and inspection…
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…
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…
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…
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…
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…
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…
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…