by
Gus Iversen, Editor in Chief | July 02, 2015
For manufacturers of certain low-risk medical devices, bringing their products to market will become much easier — and less expensive.
The standard fee for a 510(k) application is $5,018, which doesn't even factor in the cost of compiling the necessary research and paperwork to recommend the product.
By making it easier for manufacturers to bring these products to market, the process of commercializing can also be completed faster.
The formal exemptions will be rolled out gradually, but the FDA will use its enforcement discretion to ignore them as they stand.
Among the devices no longer subject to 510(k) clearance are trocars, first aid kits, teething rings, surgical drapes and pads, opthalmic sponges, and spine curvature monitors.
The full list can be found in the FDA's
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements, issued on July 1st.
