New Medical Device and Product Marketing Approvals

Every month, thousands of new medical devices are submitted for marketing approval from the FDA. Many of these devices are turned down or re-classified, but hundreds of them end up getting approved for marketing nationwide. There are several types of approvals companies can seek from the FDA, which are PMA, 510(k), and HDE. We will review each type of approval in this article and provide a few examples of the devices approved this month. Manufacturers and supply companies must also get their items re-approved each time a change is made, such as different electronic boards, lubricants, or even when software is changed. These "re-approvals" seem to make up the majority of the applications for approval, but there are still many new devices and companies who are striving to improve medical devices and equipment world wide.

Pre Market Approvals (PMA) are for devices that require more complete testing for functionality and safety, because they are new to the market or are high risk devices. A few recent devices that have been approved under this category are a Harmony HiResolution Bionic Ear System, which was a model change that needed to be approved, not a brand new product, as well as a Open Pivot Heart Valve. The heart valve manufacturing location was approved by the FDA.

The next category is the 510(k) category, which is for medical devices that are similar to other medical devices that are already legally marketed for the exact same use. When a device is being marketed for a different use, it would most likely need a PMA or HDE approval instead. Some examples of recently approved medical devices that fall under this category are the 101 Total Hip and The G60 Diagnostic Ultrasound System. Both of these items were medical devices that fell under this category, because they were substantially equivalent to existing devices being used for the same thing.

The third category is Humanitarian Device Exemptions (HDE). These are devices that are considered less of a risk, because they are not used with the mainstream public. To qualify for HDE approval, it must be a medical device or diagnostic tool used on a condition or disease that affects less than 4000 people within the USA each year. Companies who market these types of devices are generally planning on taking a loss when bringing these products to market. When a product is only designed to work with less than 4000 people each year, the costs and expenses of getting this product to marked will generally outweigh the profits a company will make.