On June 30th, the US Food and Drug Administration (FDA) announced the intent to exempt 120 medical device classes with the goal to make it easier for companies to market devices. These devices will be exempt from the review requirements and premarket notifications (i.e. 510(k)).
FDA regulation has three classifications for medical devices; low, moderate and high risk. Low risk medical devices have fewer costs and regulatory requirements; therefore manufacturers often desire that their products meet this category.
More details and a list of the 120 types of medical devices can be found in the new FDA guidance released July 1, 2015 entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.”
FDA should change the regulations to exempt this list of devices from premarket notification ultimately; however, per Alexander Gaffney’s article in www.raps.org, FDA says it won’t “enforce compliance with 510(k) requirements” in the meantime, and will not require companies to submit a 510(k).