Medical Device Testing: Start With a Strategy and Plan

Most medical device manufacturers must first receive approval from the U.S. Food and Drug Administration (FDA) before they can market a medical device. Device manufacturers must demonstrate that their device is safe and effective for the intended application. The tests that must be performed vary with the device, application of the device, and components of the device, such as coatings, as well as the length of time that the device may be used in a patient. To prevent delays in the FDA review process, manufacturers must ensure that they complete the necessary tests and avoid wasting time on tests that are not required or do not add to the assurance of safety of the product.