Medical devices are required to undergo FDA review and approval before being marketed for sale in the United States. In order to achieve this approval, the appropriate application(s) must be submitted to the Agency. The applicable application and regulatory requirements vary depending on the device’s classification. As such, the successful classification of your device is imperative.
Lexium consulting has the knowledge and expertise to help you determine the correct classification for your device and assist with the production and submission of your application.
A 510(k) is a premarket submission which demonstrates that the device in question is substantially equivalent to a legally marketed medical device and is not subject to a PMA. 510(k) submissions are the most common medical device submission, and FDA-clearance of this application is required before applicable devices can be marketed for sale in the United States.
Lexium Consulting Team members has substantial experience developing and submitting 510(k) applications. We have compiled substantial of 510(k) submissions . We have a proven track record of success with the FDA and are highly qualified to assist you through the submission process.
Premarket Approval (PMA) is the regulatory and scientific process used by the FDA to review and evaluate the safety and effectiveness of certain Class III medical devices. Medical devices that are considered high-risk and must obtain an approved PMA from the FDA before the device can be marketed for sale in the United States.
PMA is the most rigorous of all the device marketing applications, and FDA approval is based on the scientific evidence presented in the submission to demonstrate that the device is safe and effective for its intended use(s). Developing a PMA application is extremely complex and time consuming. Due to the Agency’s requirement that sponsors provide clinical evidence of the device’s safety and effectiveness, developing a successful application requires a significant amount of planning, preparation, and resources. Getting the submission right the first time is critical to the sale of your device, and we can help you do just that.
We work with you through every step of the PMA process. Together we will compile an application that is ready for review by the FDA.
Call us for your USFDA 510K requirements