The FDA is about halfway through a retrospective study of its pre-market approval program, a review that could result in some devices being removed from the highest-risk category, according to Dr. Bill Maisel, deputy director for science at the FDA’s Center for Devices & Radiological Health.

Maisel, speaking before a group of medtech executives in Waltham, Mass., yesterday, said the FDA would be completing its review of the PMA program in 2015.

"We’re going to see if we can shift some of the pre-market data to post-market," he told the crowd at MassMEDIC’s annual FDA update.

Maisel said the FDA is conducting a review of the PMA process back to its inception in 1976, including whether or not some devices, which were once classified as "high risk" can be reclassified in order to improve the process of approving medical devices for market.

Maisel also highlighted the agency’s improvements in speeding up timelines for both PMAs and 510(k) clearances, saying the FDA has done a better job of improving its customer service.

He also discussed some of the watchdog agency’s views on regulation of mHealth devices, stressing that the FDA is "platform agnostic" when it comes to mobile apps.

"What matters is the function of the product, whether it’s on a mobile app or not," Maisel said. "An EKG [device], whether it’s on a table or in your hand, is still a medical device and we’re going to regulate that."

In addition, he touched on the FDA’s recent guidance on medical device cybersecurity, saying that the agency is going to start asking questions about whether a risk analysis for potential hacking attempts or data breaches has been performed by the manufacturer.

"It’s unlikely you’ll see the FDA be very prescriptive about what to do with your device, but we will be asking questions," Maisel said.