FDA Pre-Sub与Q-Sub：会议、时限与指南

How does an FDA Pre-Sub work? You send specific questions before a 510(k), De Novo, PMA or IDE, and FDA answers in writing, with an optional meeting. Here is the clock. A Pre-Sub is one type of Q-Submission. There is also the Submission Issue Request, after an FDA hold letter; the Study Risk Determination, for a planned clinical study; and the Informational Meeting, where FDA staff generally just listen. For a Pre-Sub, FDA runs its acceptance check within 15 days. Written feedback comes within 70 days, and at least 5 days before any meeting. Meetings usually land on day 70 to 75 and normally last one hour. Keep it small. FDA says the most effective Pre-Subs typically have no more than 7 to 10 questions, including sub-questions, across no more than four substantial topics. Start with three things. One: ask specific questions, not for a pre-review. Two: propose meeting dates around day 70. Three: send your draft meeting minutes within 15 days of the meeting. Fewer questions, sharper answers. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.