Breaking Records – Traditional FDA 510(k) Cleared in 18 Days

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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 rate 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.

LICENSALE® is an all-in-one global regulatory affairs system. It comes complete with the knowledge and assistance of Arazy Group regulatory experts or it can be used as stand alone Medtech registration management software to independently process all your registration activities worldwide.

LICENSALE® has been in use since 2013, processing thousands of product registrations, world-wide.  LICENSALE® 2.0, released in April 2020, provides real-time management of any registration type (initial, amendments, renewal, and transfers) and information on the progress and maintenance of such registration processes. It offers a one-stop solution for exchanging regulatory information, collecting compliance documents, reviewing documents, providing consultation, preparing submission files, and securing the approval once granted.

Interested in simplifying and streamlining your clearance process to the US- FDA or any other regulatory authority in over 140 countries?  Learn more about our regulatory technology, by emailing us at info@arazygroup.com or joining one of our multi-language weekly webinars.

Arazy Group Consultants Inc.

#200- 1333 Johnston St.

Vancouver, Canada

www.arazygroup.com

+1 604.681.6888





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