FDA mHealth Proposal ‘Big News'

By Katie Wike, contributing writer

The FDA released a proposal which would loosen the requirements for certain mobile devices. 

The FDA’s latest mHealth draft guidance reduces approval requirements for certain mobile devices. The agency proposes to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers go through the 510(k) process.

“This is big news, and a huge boost to the [mobile health] industry,” the mHealth Regulatory Coalition’s Bradley Merrill Thompson wrote MobiHealthNews in an email. “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. My hat is off to FDA.”

Among those being deregulated are some smartphone enabled devices including thermometers, smart body scales, stethoscopes, and ophthalmic cameras. Other devices identified by the FDA proposal are:

• anesthesiology devices
• cardiovascular devices
• dental devices
• ear, nose & throat devices
• gastroenterology and urology devices
• general and plastic surgical devices
• general hospital and personal use devices
• neurological devices
• obstetrical and gynecological devices
• ophthalmic devices
• physical medicine devices

iHealth Beat reports the draft guidance states, "The FDA believes devices identified ... are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness."

Thompson told mHealth News that the 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."