Article Excerpt: The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their wares as medical devices or quality systems requirements. While today’s announcement is just a proposal and requires the usual public comment period and so on, the FDA said it would not enforce 510(k) requirements for the devices it listed and it doesn’t expect companies making these devices to submit 510(k)s for them in the meantime.
Full Article: http://tinyurl.com/p6cn58r
Article Source: mobihealthnews