FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening.1
Devices and device led combo products that are required to submit either a PMA, 510(k) or a De Novo are eligible for this program. Under the ‘Safer Technologies Program’ aka ‘STeP’, manufacturers can expect an expedited assessment and review process for their device while still keeping the same regulatory requirements for premarket submissions.
The factors considered while evaluating the eligibility of a product for the STeP are:2
- The severity of the disease/disorder being treated or diagnosed by the device.
- Should not be eligible for the Breakthrough Devices Program
- How a device in STeP is expected to improve the benefit-risk profile of a treatment or diagnostic compared to alternatives for the identified disease or condition, as well as the significance of the expected improvement.
- The device should be subject to marketing authorization via PMA, De Novo, or 510(k) pathways.
FDA might accept multiple devices into STeP that are intending to address the same safety issue or improvement.
This program will greatly promote innovation in the medical devices, advance patient care and facilitate timely access to safe and effective medical devices. The draft guidance for the ‘STeP’ was released on September 19, 2019 and is open for comments from the industry until November 11, 2019.
If you would like to submit your comments on the draft guidance, the docket can be found here: https://www.regulations.gov/docket?D=FDA-2019-D-40481
Have questions? Reach out to us at 248-987-4497 or email email@example.com.
1FDA (Sept 2019) Safer Technologies Program for Medical Devices retrieved on 09/19/2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medicaldevices?utm_campaign=091819_FIB_FDA%20issues%20draft%20guidance%20on%20the%20Safer%20Technologies%20Program&utm_medium=email&utm_source=Eloqua
2FDA (Sept 2019) Safer Technologies Program for Medical Devices retrieved on 09/19/2019 from https://www.fda.gov/media/130815/download