Before being able to market a device intended for human use in the United States, it must be cleared or approved by the FDA. Whether clearance or approval is required, depends on whether it can be proven that the new device is substantially equivalent, or at least as safe and effective, as a device already marketed, commonly referred to as the “predicate” device. In the case that this applies, a 510(k), or Premarket Notification, must be made to the FDA for clearance[A]. In the submission, the device is compared to the predicate to demonstrate that it is substantially equivalent by providing the necessary support to do so. Though some devices are exempt from premarket approval, all medical devices must be cleared by the FDA before commercial distribution.
Once submitted, the 510(k) the review process begins, first with an Acceptance Review to determine if the submission meets the minimum requirements for acceptability. Afterwards, it is moved into a Substantial Review, where a comprehensive review of the material is done. Generally, the goal of the FDA is made within 30 to 90 days, depending on the submission type and excluding any time the submission is placed on hold. Once the device has been …show more content…
But, certain changes made to a device currently in commercial distribution also trigger the need for a 510(k) submission. According to the 21 CFR 807.81, if the device will be “significantly changed,” including changes to resolve a recall or corrective action, labeling, technology or performance, or material, premarket notification is required[F]. The FDA provides additional guidance on determining when to submit, such as various flow charts for which types of changes can be done to the device and which changes would require a submission. If no 510(k) is required for the specific change, the change must still be