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
