Third-Party 510(k) Reviews - Slash Clearance Times
Two 510(k) submissions, both for Class II devices, went through third-party review by CITECH and were cleared by FDA less than 2 months after CITECH's review began. One of them, for a new diagnostic ultrasound system, sailed through the entire process in just 26 calendar days! The second 510(k), for an automated noninvasive blood pressure (NIBP) monitor, took 57 days, compared with an average of 320 days for recent NIBP monitor submissions directly to FDA. This time includes CITECH's primary review, FDA's final determination, and any manufacturer response time.
Can saving months in new product release mean extra sales for you?
CITECH 3rd-Party 510(k) Review Offers Non-Adversarial Process
Does it seem that your 510(k) always lands at the bottom of the FDA reviewer's pile? Do you see the reviewer as your adversary? This won't happen to you when you choose CITECH as your FDA-accredited third-party reviewer. And now, dozens of more Class II devices are eligible for third-party review, making the program attractive to more companies.
CITECH, the independent medical device testing laboratory, builds on an impressive record as an accredited third-party reviewer that began with FDA's 1996 pilot program. "We're excited about the expansion of the third-party program," said Robert Mosenkis, CITECH president. More than 150 Class II products, including such popular devices as electrosurgical units, laparoscopes, and infusion pumps are eligible. In addition, all Class I devices that still require 510(k) submissions (e.g., gloves) are eligible for third-party review.
Easy Access to Your Reviewer
While a jump on the market may be your major reason to choose CITECH over FDA for primary review of your 510(k), another big benefit is faster, friendlier, more direct access to the reviewer. According to Mosenkis, "Companies tell me that some FDA reviewers don't contact them until nearly 90 days after they submit the 510(k), and then it's with a long list of deficiencies. Companies also say that it's hard to reach their reviewer on the phone. CITECH addresses these issues."
CITECH subcontracts the detailed review of 510(k)s to ECRI, which assigns each one to a specialist in that product area. "The primary reviewer for each 510(k)," explains Mosenkis, "is someone who knows how that device is used in clinical practice, and doesn't need to be brought up to speed." The reviewer is in contact with the submitter during the review process, so any problems or deficiencies are dealt with as they are found. The submitter is also welcome to call the reviewer.
CITECH's proposal to the company includes a guaranteed turnaround time for the primary review, with a reduction in fee for each day it's late. FDA has a goal of completing its final supervisory review of these 510(k)s within 30 days. "They usually do much better than that," Mr. Mosenkis commented.
The fee charged for a 510(k) review is based on CITECH's estimate of the review time. This, in turn, depends on the length, complexity, and organization of the 510(k) itself. If the company submits a draft or final 510(k) for quotation, CITECH provides a firm proposal of time and cost at no obligation. If the company is unable to submit the 510(k) or a draft, a preliminary time and cost proposal is based on discussions regarding the submission.
CITECH is known for safety and performance testing services to the medical device industry. ECRI, a Collaborating Center of the World Health Organization, is known worldwide for its assessment of healthcare technology.
CITECH, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Tel: 610-825-6700; Fax: 610-834-1275.