Device Clearance in Less Than 90 Days: Analysis & Tips

Summary

There are approximately 3,500 medical device Premarket Notifications a year that are received by the Center for Device and Radiological Health (CDRH) at the Food and Drug Administration (FDA). Section 510(k) of the Food, Drug and Cosmetic Act (FD&C Act) requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance.

While the FD&C Act indicates this timeframe for a 510(k) submission, assuming that 90-days is sufficient may be imprudent. A device cannot be marketed until FDA finds it “substantially equivalent (SE)” within section 513(i) of the FD&C Act.

• What is the actual time that can be expected from submission date to FDA response?
• What factors contribute to the actual observed time frame?
• Can these factors be addressed proactively to ensure the window of 90-days is met?

This white paper is intended to provide responses to these questions on 510(k) submissions.