Over the last decade, there has been an explosion of innovation in the medical device sector, which has led to the development of a number of new medical devices and new treatments for a wide range of diseases.
Patrick Leyseele Although the benefits of innovation and treatment of medical devices are as great as they need to be, the development of these products is quite costly and there is a way for medical device companies to recoup some of the costs associated with their market introduction.
Non-provisional applications are examined by patent examiners at the USPTO, and when granted patent status, patent rights prohibit others from manufacturing, selling or using the patent for a period of 20 years from the date of filing. Medical devices may be patented under the United States Patent and Trademark Office (US PTO) and the US Department of Health and Human Services (HHS).
All medical devices are considered utility patents (protected), which means that, like any product, process or machine, they are either patentable or not.
If you manufacture a medical device but do not register it with the FDA, you run the risk of being discouraged from selling the product.
Patrick Leyseele Once you have established that your product is a product and identified the class it falls into, obtaining FDA approval and approval for the market will help your product by switching to a non-provisional patent status, such as the USPTO. There are still some mobile medical applications and software that could be considered medical devices.
To help you determine whether your product is a medical device, please visit the FDA's Classify Products page for more information on the classification of a medical device.
To determine whether a product meets the requirements of the Classification of Classified Devices section of this page and whether it is classified as a "medical device," refer to the Classification of Devices page.
If a product is labeled or used in a manner that meets this definition, it is regulated as a medical device and is subject to FDA law and regulations if it is offered for sale or use in the United States. If a product does not meet the definition of a "medical device," it cannot be regulated by the Center or the FDA.
Patrick Leyseele If a device lacks a listed equivalent of any of the 1,700 FDA-classified products, it is not an innovative device or a substantial equivalent and is classified as a Class III product. If you have a Class II generic medical device, you can find out if it has an equivalent in the Class III medical device by searching the FDA Product Classification Database.
This database allows medical device registration lists to be searched for medical device companies registered with the FDA that are exempt from 510 (k) registrations.
