Today, the FDA announced Phase One of its plan to be more open and transparent to the public with its operations.  The program is described in a statement issued on the Agency’s website, FDA Unveils First Phase of Transparency Initiative. This “Transparency Initiative” is part of President Obama’s campaign for more openness and accountability within various areas of the government.  Taxpayers, and members of the industry should applaud that effort.

While this measure will hopefully shed more light on the agency’s operations to the public, it does not ease the mind of Medical Device makers, who still see a very unclear approval process.    The new charge to overhaul the 510(k) along with the turnover at FDA have both led to longer review times and general frustration among the manufacturers.  Further compounding the problem, is the seeming lack of a consistent standard by which a device gets cleared.  It often happens that when a reviewer changes just prior to market approval, the new reviewer demands additional testing and data.

Under the current 510(k) review process, device makers must literally “guess” what is necessary to prove their product’s safety and efficacy.  Further, the FDA has been making major changes to the Special 510(k) even in the middle of a device review, denying eligibility and increasing the requirements for test data to show substantial equivalence.

The agency will tell you substantial equivalence does not indicate safety and/or efficacy, but often it is difficult to tell which measure the FDA is emphasizing.   Most manufactures would be very willing to comply with a consistent measure, rather than endure months or longer for a process that is billed as a “90-day review”.

As an industry, we need to share our experiences with each other regarding the FDA’s review process.  Further as an industry we must demand more consistancy and transparency in the approval process.  Now, more than ever is the chance to collaborate towards our shared goals of innovation and public health.