Deanna J Carter - Comment

There are a number of terms that need to be clarified: "intended use," "indications for use," "technological characteristics," etc. It was extremely disappointing that reviewers within CDRH have such differing thoughts/opinions on the definition of these terms and their application. It lends to the ongoing hope of "I hope I get a good reviewer." Industry should not hope to have a "good" reviewer but rather, industry should know exactly what is expected and required of them. Likewise, industry should know what to expect from FDA. It is also disappointing that FDA subcumbs to political pressures to clear/approve devices. Grant it, this is not the norm; however, there should be clear requirements and everyone should be required to satisfy them. Although it is a great idea, asking mfg's to provide addt'l data to FDA with regards to changes and the justification for not submitting supplemental or new 510ks will be extremely burdensome. Will the list of changes just merely be submitted to FDA and get lost in a black hole or will there be a response time in which FDA will respond with "proceed" or "halt production?" I recommend that no FDA decision is required to continue production/sales. In fact, I recommend that mfg's keep a list of changes and their corresponding justifications for not submitting a supplemental or new 510k on file for FDA to review while auditing the site. This eliminates the need for "random" reviewers to get up to speed with the company, background, product, etc and promotes the relationship between the Mfg and the Mfg's FDA auditor. Ultimately, this would save FDA time and would create value whereas sending in a list to FDA to a random reviewer is burdensome, time consuming, and potentially disruptive to the commerical/patient market.