FDA Finalizes Breakthrough Device Guidance, Outlines Safer Technologies Program

Regulatory NewsRegulatory News | 18 December 2018 |  By 

The US Food and Drug Administration (FDA) on Tuesday finalized guidance detailing its breakthrough devices program and announced plans to bring safer medical device alternatives to market via a new safer technologies program (STeP).
“We continue to encourage device manufacturers to consider the breakthrough devices program for innovative, lifesaving devices, and, in the near future, our goal is to have STeP as an option for those devices with new advances and adaptations that could lead to a reduction in risk to patients or their providers,” said FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren.
Breakthrough Guidance
The 30-page guidance finalizes a draft version released in October 2017 and includes clarifications to address comments received during the public consultation.
The breakthrough devices program was created by the 21st Century Cures Act and supersedes and combines several of the agency’s earlier programs to speed access to promising new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.”
Breakthrough designation can be applied to devices subject to FDA’s premarket approval (PMA), de novo and 510(k) pathways and provides guaranteed priority review status for designated devices. However, unlike FDA’s priority review program for drugs, devices granted priority review are placed at the top of the review queue and are assigned additional review resources but are not guaranteed a faster review.
The final guidance clarifies that devices granted designation under the agency’s previous expedited access pathway (EAP) are considered to be part of the breakthrough devices program.
Additionally, FDA specifies that breakthrough devices that receive marketing authorization “have no additional limitations solely by virtue of their designation.”
The final guidance has also been reordered to move the program features section to after the section on designation requests.
Safer Technologies Program
FDA first introduced the concept of the STeP program in its Medical Device Safety Action Plan released in April 2018.
Under the program, FDA says it plans to apply features from the breakthrough devices program to devices that otherwise would not qualify that offer safety improvements over currently available devices.
“We envision that STeP would be available for devices that do not otherwise meet the criteria to be considered a breakthrough device in our current program, but through innovative designs, have the potential to be significantly safer than currently available alternative treatments or diagnostics,” Gottlieb and Shuren said.
While the full details of the program are still being worked out, Gottlieb and Shuren said the agency will be releasing more information on STeP next year.
Guidance, Statement


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