T3 Labs is pleased to share that our sponsor Surefire Medical has received 510(k) FDA clearance for Surefire Precision Infusion System in record time.

T3 Labs provided preclinical GLP testing services for “Design Validation of the Surefire Precision Microcatheter” essential to the 510(k) submission. According to our sponsor Bryan Pinchuk, Project Manager at Surefire Medical, the direct-to-tumor embolization device achieved FDA 510(k) clearance just 76 days after submission.

“Every day we are unable to provide our devices to the patient care teams that need them, not only delays critical improvements in care but also delays company-wide goals and objectives,” Bryan said. “Being confident that our preclinical CRO partner T3 Labs delivers thorough GLP reports that generate regulatory clearances as swiftly as possible is immensely valuable to us.”

Only 22 percent of devices achieve FDA 510(k) clearance within 90 days

According to a review of publicly available data, medical device consulting firm Emergo found that over the past 15 years, the FDA has been taking progressively longer to clear 510(k) submissions, which now averages about six months (180 days).(1) More specifically, just 22 percent of devices are cleared within three months (90 days).

“We take great pride in getting it right the first time ensuring the most efficient use of resources for all of our preclinical GLP sponsors,” T3 Labs Program Director Deepal Panchal said. “We congratulate the entire Surefire Medical team on the success of Surefire Precision.”

Read the entire Surefire Medical announcement release here.

Talk to us about your preclinical and GLP for FDA 510(k) needs

If your medical device or pharmaceutical company is seeking 510(k) FDA clearance and needs the highest quality preclinical GLP testing, training or translation services, contact our team at info@t3labs.org or call (404)894-5227