The summer of 2014 marked an important milestone for LICENSALE.COM™, Arazy Group’s product registration system. Hanin Medical’s SAAD patient monitor, the first Saudi designed and manufactured device of its kind to be cleared for sale in the EU and USA, received its 510(k) clearance in August 2014. Although this was an achievement on its own, it was the latest in an unbroken period of 11 successful 510(k) clearances submitted between 2013 and 2014.
FASTER REVIEW TIMES
Since the Medical Device User Fee and Modernization Act (MDUFMA III) was reapproved in October 2012, Arazy Group has applied its innovative LICENSALE.COM™ process to new 510(k) submissions, resulting in zero Not Substantially Equivalent (NSE) letters (100% of 510(k) submissions were cleared) and review times have been reduced since the implementation of LICENSALE.COM™. While the average time for review is set between 90-110 days, several of the clearance letters issued in the last 16 months have been completed in 60-70 days. VisionSense’s VS3 Stereoscopic High Definition Vision System traditional 510(k) application, for example, was submitted on April 18, 2014 and was cleared 67 days later on June 26, 2014.
How is this achieved? The LICENSALE.COM™ process has prevented the review clock from pausing by eliminating Refuse to Accept (RTA) deficiencies during screening and keeping substantive review questions to a minimum (or, in some cases, avoided altogether), allowing FDA reviewers to meet their target performance goals and clients to get their products to market faster. The LICENSALE.COM™ process achieves this with its innovative and proprietary design, constructed over a period of four years by regulatory experts in their fields.
The application for Ultrasonix’s (Analogic) GPS ultrasound nerve block guide kit, for example, was originally submitted by a traditional consulting company as a third party review submission. By the time the submission came to Arazy Group, it was already 175 days into RTA deficiencies. LICENSALE.COM™ was not only able to respond to the RTA deficiencies noted by the FDA within a few days (and thereby saving the 510(k) from being withdrawn as an NSE), but was also able to address substantial review requests resulting in 510(k) clearance on a submission that was days away from receiving an NSE determination.
INNOVATIVE REGULATORY SUBMISSIONS
Some delays were avoided altogether through innovative submission practices and expert knowledge of regulations. When the material supplier for the FDA Class III Ameco hemodialysis catheter changed the formulation of the raw material, LICENSALE.COM™ was able to submit the modification as a Special 510(k) notification and, as a result, received clearance in only 30 days. Had the modification been submitted as a traditional application, review time would be a minimum of 90 days – not including the time required to prepare the submission and address AI review cycles.
Similar to the case of Ameco, changes or delays to the products themselves can be unavoidable, but regulatory delays need not necessarily follow as a result. Cardiac Designs designed a Holter monitor and EKG analysis software but experienced delays with the Holter monitor design. With LICENSALE.COM™, Arazy Group experts were able to get the EKG analysis software cleared for a generic indication to be used with compatible monitoring devices on the market, getting Cardiac Designs’ software to market before the hardware component was completed.
Expert knowledge of USA FDA regulations allowed Equashield, another Arazy Group client, to gain a significant regulatory advantage over their competitors. Equashield was prevented by the FDA from including a seven-day microbial ingress prevention claim in their Indications for Use Statement (IFUS). Through the LICENSALE.COM™ process, Arazy Group experts were able to include this claim in the 510(k) Summary, allowing Equashield to include the desired claim in their cleared labelling and have a critical advantage over its competitor, Becton Dickinson. As a result of its license advantage and product excellence, Equashield was able to report significant market growth and secure several multi-million dollar accounts, including world-renowned New York cancer hospital Sloan-Kettering.
Learn more about how Arazy Group’s LICENSALE.COM™ propriety regulatory affairs service technology can benefit your product registration needs with the USA FDA and regulatory authorities in another 100 countries around the world. Visit us at licensale.com.