After a letter from FDA
Deficiency letter answered, Q-Sub prepared
FDA sent Ortolog a long list of problems. They had 180 days to reply. We used a small part of that time.
- Answers sent long before FDA's 180-day deadline
- Months earlyAnswers sent long before FDA's 180-day deadline
- For Complizen to turn FDA's letter into a plan
- SecondsFor Complizen to turn FDA's letter into a plan
- To prepare their Q-Sub request
- 3 daysTo prepare their Q-Sub request
A long list of problems, and a hard deadline
Ortolog had already sent a 510(k) to FDA. Another company prepared it. FDA replied with an Additional Information letter. People also call it a deficiency letter. FDA calls it an AI letter, and it has nothing to do with artificial intelligence.
The letter was long. It listed many real problems. Each one needed an answer that FDA would accept.
An AI letter starts a 180-day clock. If you miss that date, FDA closes your submission. You start again, and you pay the fee again. Ortolog came to us with the clock already running.
We turned the letter into a clear plan
We put FDA's letter into Complizen. In seconds it produced a plan. It separated every problem, explained what FDA was really asking for, and said what we needed to fix it.
Our regulatory team checked that plan against the letter before Ortolog saw it. Then we worked through the list together and wrote the answers.
We joined the call with FDA. Some points needed discussion, not just an answer. That is easier to do in a live conversation than on paper.
We also prepared a Q-Sub request. A Q-Sub lets you ask FDA a question directly instead of guessing. The work was done over three days.
FDA accepted the answers, and most of the time was saved
We sent the answers and FDA accepted them. Most of the 180 days were still unused.
That spare time is important. If an answer is wrong and no time is left, the submission closes. Finishing early gives you a second chance.
What Ortolog got
- Every problem in the letter, separated and explained in simple words
- A written answer to each one
- The FDA call, attended with the client
- A Q-Sub request, prepared
- The answers sent, and accepted
Where it stands
Ortolog still works with us on this file.
The services we used
