The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to provide medical device manufacturers with greater clarity on when changes to a currently approved device trigger the need for a new premarket review and approval.
Under current FDA regulations, medical device manufacturers are required to submit a new 510(k) application to the agency whenever changes or modifications to an existing, approved device alter its intended use or could significantly affect its safety or effectiveness. According to the FDA, the updated draft guidance is “intended to help manufacturers determine when a change is significant enough to warrant FDA review.”
Updates to the recommendations in the draft guidance, which was released in early August 2016, include:
- Recommendations for manufacturers to conduct a risk-based assessment to determine whether a modification to a device could significantly affect its safety or effectiveness;
- Updated sections to provide further clarification on changes to labels, materials, technology, engineering or performance that might trigger the need for a new 510(k) filing;
- Examples of specific changes that would likely require the filing of a new premarket notification, as well as those that would not.
Guidance documents are intended to present the Agency’s current view of a given topic and are not binding on either the FDA or the public. Nonetheless, they offer an important perspective that can help manufacturers and importers achieve compliance with FDA requirements.