Dec 19, 2018


  • US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products.
  • The new program incorporates elements of prior FDA programs including the Expedited Access Pathway (EAP) and Priority Review program.
  • Devices that use novel and cutting-edge technologies to address life-threatening or permanently debilitating diseases may qualify for the new program.

The US Food and Drug Administration has finalized details of a new registration route for breakthrough medical devices first announced in 2017.

Final guidance from FDA on its Breakthrough Devices Program covers cutting-edge medical devices as well as combination products with devices as primary components developed to more effectively target life-threatening or debilitating diseases and health conditions. These devices would otherwise undergo Premarket Approval (PMA), 510(k) premarket notification or De Novo classification request review in order to be sold in the US.

As previously reported by Emergo by UL, the Breakthrough Devices Program replaces FDA’s Expedited Access Pathway (EAP), established in 2015, as well as the regulator’s Priority Review Program. In addition, the new program incorporates the agency’s Innovation Pathway pilot program launched in 2011. Devices that previously obtained designation under the EAP now fall under the Breakthrough Devices Program, according to the agency.

Key criteria for program qualification

In order to qualify for participation in the Breakthrough Devices Program, a device must meet two key criteria:

  • The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.
  • The device represents breakthrough technologies that have no cleared or approved alternatives already available on the US market; offer significant advantages over existing alternative devices; and for which availability is in patients’ best interest.

“One thing it is important for manufacturers to understand is that this program does not take the place of a PMA, 510(k), or De Novo premarket process, but rather it is a means to expedite the device evaluation using whichever premarket pathway is needed,” explains Audrey Swearingen, Regulatory Affairs Manager at Emergo by UL.

“The program is not intended to simply be an expedited review of the submission data, but a partnering with FDA where agency reviewers are more involved early in the development of the device in order to ensure a more streamlined, successful clearance or approval of the submission,” Swearingen adds. “And of course it is only applicable to certain devices that meet the two key criteria, which need to be well supported when a sponsor requests designation as a Breakthrough Device.”

Components of the Breakthrough Devices Program

FDA’s final guidance involves two main phases: a Designation Request phase wherein device manufacturers and sponsors request Breakthrough Device designation, and a second phase that includes processes to expedite device development and prioritize premarket reviews.

Specific features of the Breakthrough Devices Program include interactive and timely communications between FDA and premarket registrants; more flexible clinical study design requirements; and expedited manufacturing inspection regimens depending on registrants’ compliance track records.

Qualifying premarket submissions will also undergo priority review at FDA, but manufacturers should be aware that such reviews may take longer due to novel scientific and technology issues posed by these devices that agency reviewers will have to consider.

Additional US FDA medical device regulatory resources from Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • US FDA medical device and IVD regulatory strategy support
  • Combination product regulatory consulting
  • Whitepaper: Understanding the US FDA medical device classification system
  • Whitepaper: Early communication with US FDA


  • Stewart Eisenhart