DuVal and Associates – CLIENT ALERT 1/2012

In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on the current 510(k) and pre-IDE programs.  We provide some practical insights on what it is like to approach FDA today on a 510(k), whether you start with a pre-IDE meeting or you get into a clinical discussion after a 510(k) submission.  This CLIENT ALERT is longer than most, but is full of practical insights and inside advice.  Here is the Table of Contents:

PART I

FDA’s Stage-Gating Review of 510(k)s

PART II

What is Producing These Clinical Requests?

--The 510(k) Standard in a Nutshell

--FDA is Seeing Many New Technological Differences

--Why Clinical Data Requests Arise—New “Types” of Questions

--FDA’s Newly Proposed Guidance Document Covers “Reference Devices”

--The Bottom Line is that Technological Issues Raise the Specter of Clinical Trials

PART III

Negotiating on Clinical Trials Using the Least Burdensome (LB) Principles

--Congressional and Industry Pressure is Mounting

--Management Podium Talk Does Not Translate into Reviewer Walk

--Alternatives to RCTs—the Least Burdensome Guidance Documents

PART IV

The Role of Pre-IDE Meetings Today

--Pre-IDE Meetings Are Not Working Well

--What If You Come Into a Clinical Discussion With FDA After Your 510(k) Submission?

--Holding Back Clinical Data in a 510(k) Submission

--FDA is Getting Better at Allowing Alternatives to RCTs

--Conclusion

READ THE WHOLE THING HERE!