Ashley Boam, acting deputy director for science and review policy at CDRH, had some microphone time during day two at the FDLI/FDA conference. Regarding the regulatory issues FDA anticipates in connection with computer and IT systems, she acknowledged that "software reliability is an issue now and will be more of an issue going forward." Hence, validation will become more important, so much so that seemingly small changes to software may raise questions of what constitutes "small."

As for wireless communication, "ensuring electromagnetic compatibility with other devices" is key, Boam said, and data integrity is a major concern given the possibility of distorted data transmission and the modern, electronics-loaded hospital room.

Boam also said that minimally invasive technologies "start to blur the lines between devices and drugs." Bench testing previously characterized a lot about a device, but "as you get to smaller technologies," reviewers will ask, "Will we be able to understand them?"

Surgeon training is becoming central to the use of many devices, and Boam said that the agency is "seeing more use of simulators for training, but this raises the issue of how realistic these simulators are." The increased technical demands of modern devices could shrink the universe of doctors who can perform many procedures, she said.

FDA, Boam said, is aware that "smart homes are becoming more a part of the environment," suggesting that the smart home is itself a kind of device.

"Is it just gathering information," or "does it tell you your blood pressure is too high?" The answer, she said, would "make it a different system" in regulatory terms.

Boam said in some instances, "Moving more things into the home sounds great," in some instances, she said. "But having patients operating these devices is a little scary" considering the cognitive impairment that goes with old age.

Another consideration is a possible uptick in false positives. "We learned some difficult lessons [about false positives] from lung cancer screening," Boam said.

"Education of review staff is going to be critical," but "we also get a significant amount of education in meetings with industry."

Given the spread of technological innovation across numerous innovators, "[f]or many technologies, you are the best source of that information," she said.

Panel moderator Mark Duval, principal of Duval & Associates (Minneapolis), a device development consulting firm, said he often finds that FDA reviewers "don't understand the law," and ask for more data than is required.

"It used to be to get a device to market it was $25 to $30 million now it's $90 million. This is unsustainable in a global economy," he said

"The concept of need-to-know vs. want-to-know is something that every branch chief deals with," Boam said. Still, "if you look at the types of products we used to receive through 510(k) and the ones we receive now," the more recent versions are an order of magnitude greater complexity.

"There are some very complicated technologies that come to us through 510(k)," Boam said, forcing agency's reviewers to learn everything relevant to the application. This sometimes means requests for information that are excessive, but the risks associated with not asking for enough are even greater.

Boam said the phrase "least burdensome ... doesn't mean lowering the bar it means the lowest level of information necessary to answer the [safety/efficacy] question. How to answer the question is not always the way we think it is, but the question should still be addressed."

Boam said, "we've made a lot of efforts to make best use of" clinical data from outside the U.S., but she said she is aware of trials conducted overseas that do not confirm with U.S. studies in important ways.