Medical Device Manufacturing Posts

The ACK Facts: Truths About eMDR Acknowledgement Files

The ACK Facts: Truths About eMDR Acknowledgement Files

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to adverse event reporting and eMDR, understanding how things work plays a role in your organization’s success. This is especially true with acknowledgement files (ACKs), as they determine whether you have met your regulatory reporting requirements. (more…)

How to Reduce Premarket Review Times

By: Mark Crawford

Medical device manufacturers (MDMs) know all too well how the FDA 510(k) review process of premarket applications for devices can seem to take forever. Although it’s easy to blame the FDA, there is a lot MDMs can do to expedite the process.

According to a new FDA guidance, total review time—the time it takes FDA to review an application and for companies to respond to the FDA’s questions—has increased, primarily due to companies taking more time to respond to requests for additional information. In addition, the number of Additional Information (AI) letters per submission the FDA sends out (“cycles”) has also increased. (more…)