Approval of Medical devices via fast track process (Breakthrough device program)

There are various treatment options available in the market to treat majority of diseases or serious conditions. However, for few the treatment options are minimal to nil. Keeping this in mind, FDA has formulated a program, known as Breakthrough Device Program (BDP). This is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or serious conditions.

The BDP replaces the Expedited Access Pathway (EAP) and priority review for medical devices. This helps the device manufacturers especially startups to interact directly with CDRH expert team to discuss any issues during device development, evaluation, and premarket review. Also, manufacturers can expect a prioritized review for their submission.

There are two main criteria given by FDA to be eligible for BDP:

a) The device should present an effective treatment for or diagnosis of life-threatening or irreversibly debilitating human disease or conditions 

b) The device must meet any one of the following criteria

-The device should represent breakthrough technology

-No approved alternative/treatment/diagnosis exists

-Significant advantage over existing technology

-Device availability is in the Best Interest of Patients

Breakthrough designation can be requested prior to marketing submission (premarket approval (PMA), premarket notification (510(k)), or De Novo classification request). Designation request should include information to describe the device, the proposed indication for use, regulatory history, how the device meets the statutory criteria for a Breakthrough Device, and what type of marketing submission planned for the subject device. 

The manufacturer can expect a letter of communication from FDA decision to grant or deny the BD designation request within 60 days.

Once and if the device is granted BD designation, the manufacturer can directly interact with the FDA and can obtain feedback on device development, relevant tests to be conducted etc. The manufacturer also receives prioritized review on future regulatory submissions, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.