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Breakthrough Designation Program: Is this an option for my medical device?

The breakthrough designation program (BDP), created by Congress as part of the 21st Century Cures Act in 2016, is an extension of the expedited access program (EAP) (April, 2015 guidance) and before that the Medical Device Innovation Initiative (MDII) and before that…  The BDP represents the next in a series of “special programs” to encourage companies to pursue “breakthrough technologies” often (but not always) in areas of unmet clinical need. FDA issued “draft” guidance on the BDP in 2017 and “finalized” guidance  in December, 2018.

The goal of the BDP and similar programs is simple: to help patients gain timely access to breakthrough technologies that have the potential to change lives without compromising safety or effectiveness – at least in theory, but is that reality?  According to recent statistics (here), CDRH has received 94 requests for breakthrough status for devices treating a variety of conditions and has granted 54 – resulting in an overall success rate of 57%. 

Simply put: when used appropriately, the BDP can offer significant advantages to the manufacturer by getting their device to market sooner.  But if the device doesn’t qualify, your BDP application will be rejected by FDA and you have just wasted a bunch of time and money!