FDA Often Sees No Data, Speaks No Data, Hears No Data—A Failure to Review Data in a 510(k)

Is FDA not reviewing your data in a 510(k) submission? Have you ever received a Not Substantially  Equivalent (NSE) letter from FDA stating your device does not meet of the definitional elements of
“substantial equivalence?” Did FDA do this without even looking at your data when your data may  have helped your device meet the SE definition?

Well join the club; where FDA sees no data, speaks no data, hears no data.

The issue of course is whether FDA in a stage-gated review should look at data submitted by the  sponsor in making a determination of whether a device is substantially equivalent (SE) or not. Stated

another way, is it acceptable for FDA to make a legal/regulatory determination in a stage-gated  review of the SE status without looking at any data? We know that FDA for decades did not apply
“stage-gated reviews” as they are being interpreted and applied by FDA today. Today FDA averts its  eyes, ears and does not even speak about data if it can avoid it.

Our firm last week submitted comments to the Docket for FDA’s recently finalized 510(k) Guidance, for  which it is seeking new input: “The 510(k) Program: Evaluating Substantial Equivalence in Premarket  Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability,” dated July 28,  2014. You can get our comments sent individually to Christy Foreman, Director, Office of DeviceEvaluation (ODE), and to the FDA’s docket, by “clicking here” in the original email or going to ur website.

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