I understand everyone's thought that FDA is biased toward companies that pay them for expedited review, however, I think there are several misconceptions and also poor structure setup that attribute t...

I think this statement if fairly accurate by I disagree on having some diagnostic devices move from Class III into Class II. The reason behind this is that diagnostic devices drive life or death decis...

From my experience in industry I think making as little claims as possible is the ideal way to go. Anything that doesn't support the main claim or function of a product should be avoided and wording i...