Address Concerns in FDA's August 510(k) Task Force Findings

U.S. FDA'S 510(K)  WORKING  GROUP  FINDINGS, AUGUST 2010

As I am actively involved in compiling and submitting 510(k)s for clients, I find the August 2010 Working Group findings on 510(k)s to be a useful tool. Current indications are that these findings may not be immediately implemented.  However, they indicate some of the concerns re: the 510(k) process, and it may be wise to address those that affect product safety or indicate a company's efforts to increase device safety. My 510(k) submissions address many of the recommendations as if they were already implemented, especially in showing safety.  I do this primarily in two ways:  1) by including an ISO 14971-based hazard analysis / risk management file that includes an FTA and FMECA; and 2) by also performing an analysis of the FDA's MAUDE database for that family of product, and include that analysis in the submission. A complete product description seems like a "no brainer", but it's best not to assume anything and address even the most basic elements in a device description and in the SE / predicate(s) comparison matrix. It is also useful to incorporate principles from all regulated industries, not just devices, to address stated and anticipated FDA (and patient / clinician / user) concerns (e.g., the ICH Q-series principles and HACCP techniques). 

-- J. E. Lincoln and Associates LLC Medical Device Consulting:  http://www.jelincoln.com/