米国FDA：医療機器規制

What does FDA do for medical devices? Its device center, CDRH, reviews devices before they reach patients and oversees them after. Risk sets the route, and the price. Most class I devices are exempt from a 510(k). Most class II devices need one: $28,653 in fiscal year 2027. A De Novo costs $191,020, and a PMA, for most class III devices, $636,732. Each route ends in its own word. A 510(k) is cleared, a De Novo is granted, and a PMA is approved. FDA's rules say a 510(k) does not in any way denote official approval. After launch, FDA keeps watching. Since February 2, 2026, it inspects device makers against the QMSR, built on ISO 13485:2016, and tracks reported deaths, serious injuries and certain malfunctions. Start with three things. One: find your device's classification regulation and product code. Two: pick the route: exempt, 510(k), De Novo or PMA. Three: register your establishment and list the device. Know your class, then your route. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.