Case Study: Anson Revises Regulatory Strategy to Obtain Fast 510(k) Clearance

As I’ve previously reported in past blogs, the average review time for 510(k)s is about 140 days with about 2 review cycles.  This week, with the help of Anson, a small device manufacturer obtained FDA Clearance on a Traditional 510(k) with a 75 day review time.  This submission was Cleared in half of the average review time with half the number of review cycles!  The manufacturer came to Anson when they were struggling through the submission review with a Third Party Reviewer (TPR).  The TPR had raised several questions around substantial equivalence to the predicates and performance testing for the subject device.  Anson made a number of recommendations including a call to FDA, a change to the substantial equivalence discussion and predicate device choices, and additional performance testing.  Furthermore, Anson assisted in the writing and editing of the submission documents to create a clear, well-written submission with all of the FDA requirements.  The client decided to withdraw their previous submission with the TPR and submitted the revised 510(k) directly to FDA.  FDA had one request regarding the addition of language to the indications for use statement, which did not result in the submission being put on hold.  The language was new for devices of this type and different from that contained in the predicate’s submission, but in-line with a recent Clearance for that device type.  This proves that FDA’s “current thinking” is constantly changing.  Nonetheless, within 24 hours of the revised documents being delivered to FDA, we had a Clearance letter coming through the fax machine!  Anson’s knowledge, experience, and expertise led this client to a fast Clearance time with minimal questions to FDA.

Back to the Blog