FDA PMA：市販前承認の解説

When does a device need a PMA? Usually when it is Class III, and FDA must approve it before it is marketed. Here is the cost and the clock. For fiscal year 2027, which began on October 1, an original PMA carries a user fee of $636,732. A qualified small business pays $159,183, and one with sales of $30 million or less may have its first PMA fee waived. A PMA does not rest on a predicate. FDA approves it on sufficient valid scientific evidence that the device itself is safe and effective for its intended use, usually from lab studies and clinical investigations. The regulation sets the clock: 45 days to decide on filing, then a 180-day review from the filing date. A major amendment can add up to 180 days. Start with three things. One: confirm a PMA is required for your product code. Two: get FDA feedback on your study plan. Three: apply for small business status 60 days ahead. Build the evidence before the filing. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.