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 "FDA Proposes to Exempt Dozens of Devices from 510(k) Requirements."
Following is an excerpt:
FDA plans to exempt an array of class II and class I medical devices from premarket submission requirements because the devices are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. FDA has proposed a list of devices that it plans to exempt from premarket submission requirements in a draft guidance posted July 31.
The list identifies the class II medical devices for which FDA believes a 510(k) review is not necessary to assure safety and effectiveness as well as certain class I medical devices which it believes no longer meet the "reserved" criteria requiring a 510(k).
Device attorney Bradley Merrill Thompson praised FDA for taking the step. "It shows that FDA is being extremely practical in reviewing its own practices, and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources," he said. Thompson, who, among other things, represents the mHealth Regulatory Coalition, pointed out that FDA's proposed list covers several devices that fall into the mobile health category, including thermometers, stethoscopes, talking first aid kits, fertility diagnostic devices and exercise equipment.
