If a device is cleared in the US for pediatric use, is that information always included in the Indications for Use portion of a 510(k) summary or is it possible to have it buried in the equivalence table under target population or somewhere else? Phrased ...

Here is the question: The Sponsor has a US IND, the planned clinical trial was not initiated, but there are other studies ongoing in country X, the sponsor reported 2 SUSAR report of the foreign study to the US IND and leads to the clinical hold of the ...

ChatGPT is everywhere these days, it seems. For those who are unfamiliar, ChatGPT is an AI chatbot that can answer all sorts of questions and spit out detailed responses. (It’s largely in the news in the U.S. right now because teachers are concerned ...

Greetings, India Local Networking Group members! I’m Ryan Connors, our community manager here at RAPS. I help make sure our groups on RegEx (including the Regulatory Open Forum, which all RAPS members can access) are providing the best possible experience ...

I am curious to know if anyone on the thread has had a timely response to a Request for Clarification (process established under PDUFA VII) following receipt of a Written Response? ------------------------------ DJ Smith --------------------------- ...