News | Radiology Imaging | November 22, 2019

FDA Continues Steps to Promote Innovation in Medical Devices

The draft guidance helps advance patient safety through the Safer Technologies Program

the Food and Drug Administration (FDA) issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks

November 22, 2019 — In September, the Food and Drug Administration (FDA) issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks.

The Safer Technologies Program, as described in the FDA’s 2018 Medical Device and Safety Action Plan, aims to spur innovation towards safer medical devices and was modeled after the Breakthrough Devices Program. As agency resources permit, the Safer Technologies Program will include features such as interactive and timely communications with the FDA, review team support, senior management engagement and prioritized review. The FDA believes this interactive and expedited feedback may reduce the total time to develop a device and achieve marketing authorization, while still meeting the agency’s gold standard for safety and effectiveness. Advances in safety and innovation are both important priorities for the agency and improvements in these areas are expected to result in timely access to devices that can increase quality of life and health benefits for patients, while still providing reasonable assurances of both safety and effectiveness.

Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)), and meet program eligibility factors as described in the guidance.

“Because technology continues to advance, patients are benefitting from more innovative medical devices that can help improve their health and even save their lives. Safety and innovation are both important priorities for the agency. Improvements in each of these areas are expected to result in increased quality of life and health benefits for patients, while simultaneously providing a reasonable assurance of both safety and effectiveness,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “To promote these goals, today we’re issuing a draft guidance on a new voluntary pathway for certain medical devices and device-led combination products that do not otherwise meet the criteria for our Breakthrough Devices Program, but through innovative designs, have the potential to be significantly safer than currently available treatments or medical diagnostics. We believe the Safer Technologies Program for Medical Devices will help ensure that we’re giving patients timely access to safe, effective and high-quality medical devices by expediting their development, assessment and review, and by facilitating the generation of the robust evidence required to support product marketing authorizations. We will do this without changing our statutory standards, data requirements or quality of review.”

For more information: www.fda.gov

Related Content

Gadolinium based contrast dye in brain MRI

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | January 17, 2020
January 17, 2020 — Bracco Diagnostics Inc., the U.
Carestream’s X-ray digital tomosynthesis functionality creates three-dimensional datasets from digital radiography (DR) that can be scrolled through similar to computed tomography (CT) imaging. It received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2020. Digital tomosynthesis uses a single sweep of X-ray exposures and streamlines operator workflow by separating the process of DT exposure acquisition from image volume formation.
News | Digital Radiography (DR) | January 15, 2020
January 15, 2020 — Carestream’s X-ray digital tomosynthesis (DT) functionality, which creates three-dimensional datas
Imaging Technology News (ITN) has been acquired by Wainscot Media
News | Imaging Technology News - ITN | January 14, 2020
January 14, 2020 — Park Ridge, N.J.-based publisher Wainscot Medi...
Videos | RSNA | January 13, 2020
ITN Editor Dave Fornell takes a tour of some of the most innovative new medical imaging technologies displayed on the
Partners of Collaborative Imaging experience billing collection improvements of over 25 percent while reducing operating costs by 30 percent

Image courtesy of Philips Healthcare

News | Radiology Business | January 08, 2020
January 8, 2020 — The $18 billion radiology industry continues to face a growing threat of consolidation, resulting i
Sponsored Content | Videos | Digital Radiography (DR) | January 06, 2020
An experienced technologist and two Agfa executives talk about what distinguishes the new Agfa 100s.
Sponsored Content | Videos | Ultrasound Imaging | January 06, 2020
The Arietta 850SE provides facilities with numerous features and functionality to get the most out of a system.
Sponsored Content | Videos | Computed Tomography (CT) | January 06, 2020
Hitachi announced the FDA clearance of its newest CT – Scenaria View – at RSNA2019.
The use of augmented and virtual reality in radiology was the subject of two articles and part of the HIMSS 2019 trends article in the top 25 list. Augmented reality is being looked at as a way to better train radiologists, allow surgeons to use medical imaging in true 3-D to better plan surgeries, and it can allow patients to better understand their conditions compared to use of traditional 2-D medical images. Photo by Dave Fornell.

The use of augmented and virtual reality in radiology was the subject of two articles and part of the HIMSS 2019 trends article in the top 25 list. Augmented reality is being looked at as a way to better train radiologists, allow surgeons to use medical imaging in true 3-D to better plan surgeries, and it can allow patients to better understand their conditions compared to use of traditional 2-D medical images. Photo by Dave Fornell.

Feature | Radiology Imaging | January 03, 2020 | Dave Fornell, Editor
January 3, 2020 — Here is the top 25 radiology articles on the Imaging Technology News (ITN) website from 2019 based
Sponsored Content | Videos | Digital Radiography (DR) | January 03, 2020
At RSNA19, David Widmann, president and CEO of Konica Minolta Healthcare Americas, discussed innovation, stressing th