The United States regulatory landscape for approving medical devices is complex and navigating it can be a challenge. According to the US Food and Drug Administration (FDA), the regulatory agency responsible for approving medical devices, the majority of 510(k) submissions have major deficiencies or are rejected the first time. Medical device manufacturers are able to reduce the chances of rejection by obtaining feedback through the FDA’s pre-submission process. By having a clear understanding of this process, companies can gain enormous benefit from the feedback given as they attempt to bring their medical device to market.

The 510(k) submission allows applicants to fast-track approval of a medical device by claiming it is “substantially equivalent” to a device that has already been cleared and marketed in the US. However, depending on the modifications made to the device, this process may begin with multiple setbacks for the applicant. A formal Pre-Submission meeting with the FDA is an opportunity for applicants to gauge the FDA’s current thinking on their device’s overall safety and effectiveness and help improve the likelihood of a successful 510(k) submission.

The Agency embraces and encourages applicants to participate in the pre-submission process and holds roughly 1,500 Pre-Sub meetings per year. According to the Medical Device User Fee Amendments (MDUFA) IV, FDA expects to provide feedback for at least 1,950 Pre-Subs received in 2022 as it strives to assure more timely access to safe and effective medical devices.