TSG Consulting urges medical device manufacturers to take advantage of FDA’s Pre-Sub meeting program
WASHINGTON DC: With the majority of 510(k) submissions having major deficiencies or being rejected the first time, scientific and regulatory experts TSG Consulting recommend that manufacturers schedule a Pre-Submission (Pre-Sub) meeting with the FDA to improve the likelihood of the medical device being approved for sale in the US market.
510(k) submissions allow manufacturers to fast-track approval of their 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 may begin with multiple setbacks for the applicant, for example the FDA might refuse to accept the submission if it is incomplete, or send a long list of major deficiencies if the submission is technically inaccurate. 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, as well as resolve any technical issues prior to the final 510(k) submission.
“Pre-Sub meetings are completely voluntary and give applicants the opportunity to interact with the FDA at no cost,” says Dr Om Singh, Senior Scientific Consultant, TSG Consulting, and former Lead Reviewer at the FDA. “The Pre-Sub program is extremely valuable for obtaining the FDA’s written feedback on existing technology, as well as helping to identify a path forward for device development and clearance or approval. FDA’s feedback is highly desirable in situations where a company may need to provide more information to ensure acceptance of the submission, for example when a device is semi-critical or critical. It is important though that FDA’s advice is sought early in order to allow for the quality of data to be improved before it is included in the actual 510(k) submission.”
To help companies prepare for a Pre-Submission meeting, TSG Consulting has published a free paper – How to get the most out of 510(k) Pre-Submission meetings with FDA. In addition to outlining the types of scenarios where Pre-Sub meetings are useful, the paper also outlines what needs to be submitted in the Pre-Sub package in order to obtain the most effective feedback. The free paper is available to download at www.tsgconsulting.com/advisory/how-to-guide-pre-submission-meetings-fda/