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 Deregulation of Several Medical Devices."
Following is an excerpt:
The U.S. Food and Drug Administration on Friday released draft guidance on a wide ranging list of medical devices--many of which fall into the mobile healthcare spectrum--which the agency believes do not require premarket notification review for safety and effectiveness. The list includes thermometers; stethoscopes; talking first aid kits; ear, nose and throat devices; general and hospital use devices; ophthalmic devices; endoscopic light; fertility diagnostic devices; and exercise equipment.
"This is big news, and a huge boost to the mHealth industry," health attorney Brad Thompson of Epstein Becker Green tells FierceMobileHealthcare in an email. Thompson represents five groups on the matter, including the CDS Coalition, the CDS Consortium, the Continua Health Alliance, the mHealth Regulatory Coalition and the Wireless-Life Sciences Alliance.
"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," Thompson says. "My hat is off to FDA."
