RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
Since our inception, we have always emphasized communication as a way of providing top-quality service. Originally the message was "over communicate" which matured into "communication is our oxygen." I note this core value because our frequent, clear, and effective communication with the FDA allowed us to obtain clearance in 95 days.
A recent analysis of 510(k) approval times up through 2011 found that the average approval time from submission to clearance is 138 days. Furthermore, submissions of devices in the same category take longer than 140 days to approve. RQS was able to work with our client and the FDA to beat the average by over 40 days!
How were we able to use communication to obtain FDA clearance more quickly than the average submission? Because of our collective experience on development teams, we understand the challenges facing our clients. As regulatory professionals, we are keenly aware of the pressures facing the FDA with the increased scrutiny placed on them by legislators, the public, and the industry in recent years. This understanding allowed us to act as a facilitator between the two parties with frequent emails to ensure alignment at all times and scheduling two phone calls (one of generous length) to discuss and clarify the submission.