CDRH's Daniel Schultz told attendees at the Medical Device Manufacturers Association annual meeting that FDA and industry have not done a very good job of communicating to the public that the 510(k) process is not the “mindless rubberstamp that some people are making it out to be.” You can read more about his comments in Jim Dickinson's Washington Wrap-Up column in the August issue of MD&DI. But below are some excerpts that may not make it into the print issue. During the question and answer period at the meeting, Schultz was asked to comment on sponsors’ perception that the advisory committee process isn’t always as predictable as planned because of panel members asking questions outside the scope of the meeting’s agenda. “We try to be selective on what we take to panel,” he responded. “We try to take devices where we have specific questions that we want [OEMs] to address as opposed to taking every PMA to panel and no 510(k)s for instance.” That approach may change. Schultz said that the focus should be on what the question is and on the type of expertise necessary to make the best decision. “So I think maybe we’ll see a more risk-based approach to making those decisions.” In terms of predictability, Schultz said one of the issues CDRH needs to focus on is making sure the right expertise is represented on the panels. Conflict-of-interest issues make that challenging, he added, because a particular discipline may be very narrow. There may be only a few experts and they may all be conflicted, resulting in “having people [on the panel] who really don’t understand the particular issue or technology, giving you a variety of opinions that may not be exactly on point.” Schultz said that in terms of transparency, there will be more panel meetings, and the advisory panels have a valuable role to play there. He added, “then it becomes a matter of figuring out how to use the system as well as we can possibly use it. “We can’t tell the panel members what to say, so obviously they have the right to ask the questions that they see fit,” Schultz said. “We can provide training for them to understand the regulatory questions we are seeking answers to, and we can focus the questions" in such a way that the panelists will help get FDA the answers it needs.