The 12-page document issued on August 1 is part of the FDA’s draft guidance for the regulation of mobile medical devices and apps. In this latest posting, the FDA has proposed that it will not require premarket submission requirements from certain Class I and II medical devices under the reserved criteria of section 501(I) of the Federal Food, Drug and Cosmetic Act of 2012.
The proposal is “a huge boost the to mHealth industry,” said Bradley Merrill Thompson, an attorney for the Washington D.C. law firm of Epstein Becker Green and counsel for the mHealth Regulatory Coalition.
He said it exempts a number of devices, such as thermometers, stethoscopes, talking first aid kits, hearing aids, fertility diagnostic devices and exercise equipment.
Thompson told mHealth News the categories targeted by the FDA are home to some of the newest mHealth innovations – like apps that turn cellphones into stethoscopes, or hearing aids and those that help users exercise – but they don’t present a risk to the user, a key ingredient to the requirement for more stringent regulation.
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The FDA “is being very practical and not wanting to apply regulatory requirements where the risks don’t merit them,” he said. “It also suggests that FDA is working hard to communicate more precisely to the whole industry, including the mHealth sector, its regulatory expectations.”
The devices identified by the FDA in its latest guidance fall under the following categories:
- 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; and
- Physical medicine devices.
Thompson said mHealth advocates are awaiting further guidance from the FDA on other categories as well. In particular, regulators will need to clarify the difference between wellness claims and disease claims, a growing concern as the mHealth industry blurs the lines between health and wellness tools and clinical tools. The agency also needs to take a closer look at accessories, or devices that, when plugged into a medical device, become medical devices themselves.
“That’s a big issue for mobile health where cell phones and other accessories are routinely now being connected to medical devices to transmit data back to a caregiver,” he said.
Another “huge issue” he said the FDA needs to take a closer look at is clinical decision support apps, which have the potential to affect how a clinician delivers care.
Date: August 04, 2014