Five Steps to Commercialization
The process of bringing medical devices to market in the U.S. can be complex, requiring an understanding classification, premarket preparation and submissions to the Food and Drug administration. Here are five steps in the process that manufacturers should consider:
- Classify your device: The first step is to determine the type of device you’re bringing to market. Class is based on: risk to patient/user, intended use and indications for use. Class I devices pose the lowest risk and are subject to general controls. Class II devices illustrate moderate risk and will require special controls in addition to general ones. High-risk, or Class II, devices requires not only general controls but premarket approval, which Class I and some Class II devices are exempt from.
- Identify the correct premarket submission: The premarket submission will depend on the device classification. The most common types of submission include the 510(k) Premarket Notification, for devices that are “substantially equivalent” to a predicate device; Premarket Approval Application (PMA), which, as the most stringent, requires valid scientific evidence demonstration a reasonable assurance of safety and effectiveness; De Novo Evaluation of Automatic Class III Designation, which provides means for a new device without a valid predicate to be classified as Class I or II, provided it meets certain criteria; and the Humanitarian Device Exemption (HDE) for devices intended to benefits patients in treatment of rare diseases or conditions.
- Prepare the premarket submission: In order to adequately prepare your premarket submission, it’s important to know what information must be included. Design controls, nonclinical testing, clinical evidence and labeling are all important items to consider, based on your device’s classification. Higher risk devices, for example, require much more detailed information, including clinical and usability data, than lower risk devices, which may be cleared with non-clinical performance data and bench test information.
- Submit to the FDA:After the information is compiled, it must be sent to the FDA for review and include an electronic copy and, in the case of a 510(k) or PMA, the associated fee. The FDA will then conduct an administrative review to determine if the submission is sufficiently complete, with review times varying from 90-180 days, based on the device class and premarket submission type.
- Establish registration and device listing: The final step is to register the device’s establishment and list with the FDA, after premarket approval is granted.