Get to Market Faster
Third-party review can slash months off the total 510(k) clearance (approval) time. With faster reviews, product launch dates become more predictable. Third-party review could make the difference between introducing your new product at the annual professional meeting and having to wait until months later. Third-party review is also friendlier, less adversarial, than FDA review.
A faster alternative
Because of staff overload, FDA sometimes takes many months to review a 510(k); this can result in lost sales. FDA has authorized a small number of outside organizations (called "Accredited Persons" or third parties) to serve as alternative primary reviewers of many 510(k)s. These third-party reviewers have shown that they can usually do the job faster than their FDA counterparts—our record is 22 days, including the final FDA decision time!
To take advantage of third party review, you prepare the 510(k) just as you would for direct FDA submission (Note: We are not permitted to help you prepare it). Then, instead of sending the 510(k) to FDA, you send it to an accredited third-party reviewer, such as CITECH. Our reviewer takes the place of the primary FDA reviewer, which is where most of the review time is typically lost. Once a contract is in place, our reviewer determines whether your 510(k) includes sufficient information to demonstrate Substantial Equivalence. Where this is not the case, we will ask you for additional information. When our review is complete, we rush the 510(k), along with our review report, to FDA for a final determination of Substantial Equivalence by the Branch Chief. This determination is usually made in 15 days or less.
Not all 510(k)s are eligible for third-party review. Any 510(k) that requires human clinical data to support Substantial Equivalence (except for NIBP devices) is ineligible. So are 510(k)s for life-support devices, life-sustaining devices, and implants. Except for these, nearly every other device that requires a 510(k) is eligible. If you’re not sure, we will help you determine whether your submission is eligible for CITECH review. No obligation.
Third-party reviewers receive no funds from the government, so we must cover our costs through fees that we charge the clients. CITECH provides no-obligation proposals for 510(k) reviews. These proposals include a fixed fee that is based on the size, complexity, and organization of the 510(k); we also provide a guaranteed turnaround time (typically several weeks) for our part of the review. Third-party reviews are exempt from the FDA review fee ($3,404 as of October 2007, $1,702 for small US companies). Thus, your real cost for CITECH review is our fee less the FDA fee.
Confidentiality? We know it’s a concern for you; it’s also a concern for us. FDA requires the same confidentiality from accredited third parties as it does from its own staff. Absolute confidentiality also makes good business sense for us. However, we are happy to a sign confidentiality agreement with you, if you prefer.
Learn more about CITECH third-party review
Contact Us
