Devices and device-led combination may be eligible for enhanced access to reviewers and priority review through the Breakthrough Devices program if they meet the program criteria:

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and
2. The device meets at least one of the following:

• Represents Breakthrough Technology
• No Approved or Cleared Alternatives Exist
• Offers Significant Advantages over Existing Approved or Cleared Alternatives
• Device Availability is in the Best Interest of Patients

The device in question may be subject to premarket notification, premarket approval, or DeNovo classification, and the Breakthrough Device design may be submitted at any time prior to sending the marketing submission. When the FDA identifies a device they feel may be eligible for Breakthrough designation, personnel will recommend that the sponser of the device consider applying to the program. This program is a replacement for the Expedited Access Pathway, and devices previously granted designation under the older pathway are now designated under the Breakthrough Devices program. 

Requests for Breakthrough Device designation use the Q-Submission (Q-Sub) process, and while it uses the common process guidance, the Breakthrough Device Q-Sub is its own type of Q-Sub. More details on what to include in the Q-Sub may be found in the program guidance and the Breakthrough Device program web page. The designation request will be reviewed within 30 days of receipt and a decision letter will be sent within 60 days. 

Once Breakthrough designation has been granted, sponsors will have access to FDA feedback through sprint discussions, requests for discussion on a data development plan, and request for clinical protocol agreement. Priority review on future regulatory submissions is also a feature of the program. You may want to view the program webinar or read the transcript for more information.

Text Copyright © 2019 Katrina Rogers