Arazy Group’s Fastest Clearance
18 Days for Traditional FDA 510(k) Clearance via the “Triage Quick” Program.
On August 14, 2020 Arazy Group received its fastest Traditional 510(k) clearance via the FDA’s new expedited 30-day Triage Quick route. This is an option that the Triage Quick program is offering any Traditional 510(k) submission that meets its criteria. The Traditional 510(k) submission, K202068, which was sent for Triage Quick review on July 27, 2020 and was cleared only 18 days later.
“Arazy Group’s clearance of eighty-four Traditional 510(k)s applications over the past 3 years is an average of 150 days. Through using its regulatory technology, LICENSALE® – Global Medtech Registration Platform, a variety of medical therapeutic and diagnostic products, including software were successfully cleared. We believe that this good standing with the FDA contributed to our submission being selected as one of the very first to go through the Triage Quick clearance program”, comments Raymond Kelly, Chief Regulatory Officer at the Arazy Group.
Raymond Kelly, CRO
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