FDA 510(k): 허가 및 제출

What does a 510(k) take now? A legally marketed predicate, proof of substantial equivalence, an eSTAR, and a fee that rose on October 1. Here is the short version. For fiscal year 2027, which began on October 1, the 510(k) review fee is $28,653, up from $26,067. Traditional, Special and Abbreviated 510(k)s all pay it. A qualified small business pays $7,163. FDA usually decides within 90 days. And use the right word for the result. A 510(k) device is cleared, not approved. FDA's rules say any claim of official approval based on a 510(k) is misleading, and counts as misbranding. Every 510(k) to CDRH, unless exempted, goes in as an eSTAR, through the CDRH Portal. If it fails technical screening, you have 180 days to send a replacement, or FDA closes it. Start with three things. One: confirm your product code and regulation number. Two: choose a predicate with the same intended use. Three: submit at least 90 days before you plan to sell. Prove equivalence, then say cleared. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.