FDA suggests deregulation of some Class II and Class I medical devices

August 9, 2014 | Reply More

The U.S. Food and Drug Administration recently proposed the deregulation of a sizeable list of Class II and Class I medical devices, sparing their makers the task of going through the 510(k) process. While the FDA made clear that the deregulatory move would not exempt device makers from appropriately registering and labeling their apparatuses as medical devices, the FDA will not be enforcing 510(l) requirements for the listed devices. These devices include clinical digital thermometers, smart body scales, smartphone-connected stethoscopes, ophthalmic cameras, and more. The full list can be found on the FDA’s website here: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf

“This is big news, and a huge boost to the [mobile health] industry,” the mHealth Regulatory Coalition’s Bradley Merrill Thompson told MobiHealthNews. “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.”

What do you think about the FDA’s proposed deregulation? Let us know in the comments below or reach out to us on Twitter and Facebook.

Read more: http://mobihealthnews.com/35378/fda-suggested-deregulation-affects-smart-scales-fertility-thermometers-some-iphone-connected-scopes/

Category: Archives, In The News, Industry News, News

Leave a Reply