FDA Senior Policy Advisor Bakul Patel

A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance for new medical devices – including smartphone accessories – that follow such standards.

In its annual update to its list of accepted consensus standards for premarket reviews of medical devices, issued last week, the FDA included several items related to data exchange. Among the standards now accepted are ISO and IEEE specifications related to point-of-care and personal medical device communication for such categories as weight scales, thermometers, pulse oximeters, glucose meters, simple electrocardiographs and other devices that are increasingly being linked to smartphones and home monitoring stations.

The FDA also added standards for risk management of medical devices connected to wireless networks.

"This is the first time to my knowledge the FDA has recognized standards for interoperability," Mary Logan, president of the Association for the Advancement of Medical Instrumentation (AAMI), told MobiHealthNews.

The AAMI and the FDA last year jointly convened a summit on medical device interoperability. A few months later, the agency and the trade group issued a report in which they said healthcare organizations needed to start paying closer attention to all the data being generated by connected medical devices.

In a post on an official FDA blog last week, Bakul Patel, senior policy advisor in the FDA Center for Devices and Radiological Health, called the recognition of standards "a first step" in achieving interoperability between devices and health IT systems. "We hope this first set of voluntary standards will encourage further efforts to identify standards and create new ones for our review, because improving the care of patients through medical devices increasingly depends on those devices and information systems being 'interoperable,'" Patel wrote.

What it means for device-makers is that they now have a new option to demonstrate efficacy of their products to the FDA in 510(k) reviews, according to Logan. "There are different paths for getting to market," Logan explained. "One of the ways you can prove your product is safe is to show that you follow standards."

Logan added that the FDA normally does not attach a lot of fanfare to the annual update of recognized standards. "They made a big deal of this. They don't usually do that," she said.

"For those not used to being in a regulated environment," Logan continued for the benefit of mobile app developers, "my advice would be to take note. This is very important."