Why choose CITECH as your third-party reviewer?
CITECH was accredited as a third-party reviewer in 1996, when the program first began, so we’ve been doing it longer than many third parties. CITECH is also accredited to review most devices that are eligible for third-party review; this isn’t true of all third parties.
CITECH is attuned to your needs. If you’re in a hurry, consider this: The 510(k)s for two different ultrasound systems received final clearance from FDA just 26 and 33 days (respectively) after CITECH’s review started! A noninvasive blood pressure monitor sailed through the entire process in 35 days, compared with an average of 320 days for other NIBP monitor 510(k)s reviewed by FDA around the same time. Of course, we can’t achieve these results for everyone, but they show what is possible, even for something as complex as a diagnostic ultrasound imaging system.
One reason for this impressive record—and perhaps the main reason to choose CITECH—is that your review will be done by a product specialist, not a generalist. We subcontract most of the detailed review to ECRI (we’re both in the same building). ECRI is the world’s largest independent assessors of healthcare technology, and it has a large staff of experts who specialize in specific areas of healthcare. Your 510(k) will be reviewed by someone who understands your technology and knows how it is used clinically; no time is lost coming up to speed. You’ll be given your reviewer’s name and phone number, and you are free to call if you have any questions about the progress of your review.
Getting started
The first step is to determine whether your 510(k) is eligible for third-party review; we’ll help you do that. If it is, we’ll ask you to send us a hard or electronic copy of the complete 510(k), or a nearly complete draft. We’ll conduct a quick examination of its size, complexity, and organization, to estimate the effort that our review will entail. From this (and in some cases, where it’s required, a brief discussion with FDA), we’ll send you a no-obligation proposal with a fixed fee and a guaranteed turnaround time for our part of the review.
When you accept our proposal and send us 3 copies of the complete 510(k), our reviewer begins checking your submission for Substantial Equivalence. Where information is missing or unclear, the reviewer will ask for additional information, but will continue with the review while you’re preparing it. When the review is complete, we send our report and the 510(k) to FDA for final decision by the Branch Chief, bypassing the primary reviewer. This determination is usually made within 15 days.
Learn how CITECH third-party 510(k) review can get you to market faster!
Contact Us
