Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled “Draft Guidance Would Exempt Some Devices from Premarket Notification Requirement.”
Following is an excerpt:
New draft guidance released by the FDA holds the potential to stimulate growth in the mobile health industry, a lawyer specializing in medical devices regulatory matters told Bloomberg BNA Aug. 1.
The draft guidance, announced Aug. 1 in a Federal Register notice (79 Fed. Reg. 44,804), outlines the Food and Drug Administration’s plans to exempt specified class II (moderate risk) and class I (lowest risk) device types from premarket notification requirements. According to the notice (FDA-2014-D-0967), comments on the draft guidance are due Sept. 30.
Bradley Merrill Thompson, a medical devices regulatory attorney with Epstein Becker & Green PC, said the guidance may positively affect the mobile health (mHealth) industry and the development of health-related smartphone applications (apps). Many of the device classifications specified for 510(k) exemption in the guidance, such as thermometers, stethoscopes, talking first aid kits, fertility diagnostic devices and exercise equipment, fall under the mHealth category, he said.
“I actually think the immediate impact of this guidance is very substantial,” Thompson said. Many of the device classifications listed in the document “are areas where many folks are developing mobile apps,” he said. He also noted that there is a keen interest in the mHealth industry developing exercise apps.
Thompson said he believes the guidance “augurs well for the future” because “it suggests that FDA is being very practical and not wanting to apply regulatory requirements where the risks don’t merit them. It also suggests that FDA is working hard to communicate more precisely to the whole industry, including the mHealth sector, its regulatory expectations.”