Developing a medical device is one accomplishment; bringing it to market is quite another. DeviceLab is a contract medical device design and product development firm with specialties in marketing. Since its inception in 1998, DeviceLab has successfully helped medical device manufacturers bring over 100 products from the concept phase to market Dac Vu, an engineer with DeviceLab, states “marketing a medical device in the United States requires passing a strict evaluation process by the FDA. Domestic and foreign manufacturers must undergo one of two evaluation processes: a Pre-Market Notification 510(k), unless exempt; or, a Pre-Market Approval (PMA).
Details of 510(k) and PMA
In general, products requiring 510(k) approval are less risky/less hazardous to humans than products requiring PMA approval. According to Vu, “the 510(k) process involves less time (taking about 2 to 3 months on average) and therefore costs much less than the PMA process. Products requiring PMA evaluation tend to have a higher risk factor, or have not been proven safe. These products are looked at with closer scrutiny and must withstand lengthy clinical testing and data analysis (over a period of 1 to 4 years on average). Plus it can cost millions of dollars.”
A Medical device classification is needed to determine which, if any, pre-market approval submission is needed. Class I devices present minimal risk to the user. They are simple in design and have been proven safe and effective. Examples of Class I include tongue depressors and arm slings. Most Class I devices are exempt from 510(k) and pre-market approval submission. Most Class II devices cannot assure safety and effectiveness with General Controls (as defined by the FDA) and typically require pre-market approval by 510(k) submission. Examples of Class II devices include x-ray systems, pumps, and surgical drapes. Class III medical devices have the most controls due to the level of risk they present to the user. These products generally lack sufficient information to assure their safety and effectiveness. Class III devices are usually involved in supporting or sustaining human life, or present an unreasonable risk of injury or illness (i.e. a replacement heart valve). A PMA submission is almost always required for Class III medical devices.
You can go to www.fda.gov to view a list of devices similar to the one you are trying to bring to market. This process is detailed and often requires a working knowledge in the field of medical device classification. DeviceLab has experienced FDA consultants who can classify your device and assist you with the FDA approval submission process.
Visit www.devicelab.com to learn more.