Classifying Healthcare Devices and Apps

The mobile health developers and innovators are very pleased with the new regulations proposed by US Food and Drug Administration. The new document was released on August, 1st as a 12-page guidance report for the regulation of mobile medical devices and apps. FDA proposed under the Federal Food, Drug and Cosmetic Act of 2012 – section 501 (1) reserved criteria that the companies that are involved in the developing of Class I and Class II devices or mobile apps are exempted from the requirements of premarket submission.

mHealth Regulatory Coalition counsel, Bradley Merrill Thomson told MHealth News that FDA is adopting a very sensible approach by targeting the devices and apps which don’t pose any direct threat to the health of the users. For example, apps that turn mobile into stethoscope or hearing aids, fertility monitors, stethoscope etc. Thomson is also serving as a practicing attorney at Epstein Becker Green law firm in Washington, D.C.

Based on the latest recommendations, the devices can be classified in the following categories:

1. Cardiology
2. Dentistry
3. General hospital and personal use
4. ENT
5. GI and Urology
6. Plastic and general surgery
7. Anesthesiology
8. Neurological
9. Obstetrical and gynecological
10. Ophthalmic
11. Physical medicine.

Thompson also said that mHealth advocates are waiting for FDA’s guidance on other categories as well. Particularly, wellness claims and disease claims need to be differentiated for regulators, as mHealth industry doesn’t distinguish between them.

These are big issues at which FDA should take a look that mHealth apps are used routinely to transmit medical data and a closer look should be taken at clinical decision apps as they affect clinical practices, he said.