Service
FDA correspondence
Deficiency letters, holds, and questions. We manage the exchange with the agency for you.
What this covers
Every submission produces correspondence. An IDE approval with conditions. A 510(k) Additional Information request. A PMA deficiency letter. A reviewer's email asking for one more table. Each one has a deadline and a right way to answer, and the answer decides whether the review cycle is the last one.
You remain the sponsor and the signatory. We read the letter, sort the deficiencies into what is missing, what is disputed, and what has been misunderstood, and draft the response item by item in FDA's own numbering. Where a request cannot be met as written, we propose the alternative and the justification.
Interactive review and Submission Issue Requests
Some questions should be asked before you run a new test. The Q-Submission program includes a Submission Issue Request for exactly that, and interactive review lets the lead reviewer resolve smaller items by email or phone. We prepare you for those calls and write the record afterward.
The clock
A 510(k) Additional Information response is due within 180 days or the submission is withdrawn. An IDE letter states its own deadline. We hold the calendar and start the response the day the letter arrives.
When you need it
The day a letter arrives: an IDE approval with conditions, an Additional Information request, a deficiency letter, or a reviewer's question in interactive review. The sooner we see it, the more of the response period goes to the work and the less to the triage.
What you receive
- The response documentEach deficiency restated, answered, and cross-referenced to the new material.
- A deficiency trackerEvery open item, its owner, its evidence, and its status until the letter is closed.
- Call preparation and summaryA briefing before each reviewer call and a written record after it.
What we need from you
- The letter as receivedAnd the submission it responds to.
- The data behind the disputed itemsRaw results, not only the summary tables.
- Someone who can decideResponse cycles are short. We need a person who can approve a change in days.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.