Hi, 21CFR806 and 21CFR1003 have to be followed together. § 1003.5 Effect of regulations on other laws. The remedies provided for in this subchapter shall be in addition to and not in substitution for read more
Hi Anon, Kevin and Richard always give good advice. I have three additional suggestions for you. a. Ask an experienced writer and native speaker of English to review the document before you submit it. read more
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 read more
Hello Shivam, I was just wondering if a study group has already been formed ? Thank you and regards, Veena ------------------------------ California ------------------------------
As and ex-FDA Investigator, I will add that Kevin's advice is spot on. The affidavit is essentially a document attesting to the truth/accuracy of some situation be it simply an affidavit that has you attesting read more
View this profile on Instagram RAPS (@regulatoryprofessionals) โข Instagram photos and videos
RAPS (@regulatoryprofessionals) โข Instagram photos and videos
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 --------------------------- ...
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
JoinMy RAPS DashboardLearn More
About UsTerms of UsePrivacy Policy