With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices
By Mark Durivage, Quality Systems Compliance LLC
The FDA’s Center for Devices and Radiological Health (CDRH) releasedthe
Safer Technologies Program for Medical Devices (STeP)
Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. The two-month delay is due to the expected time to “operationalize” the program, which is a voluntary program applicable to “certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.”
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IMPROVED sun safety measures may soon be installed at an East Ipswich water park amid calls from parents regarding the dangers of uncovered playgrounds.
Amanda Fay was among several residents who took to social media on Monday, revealing she feared her children were at risk of being burned by equipment which was frequently exposed to harsh sunlight.
She has since called upon Ipswich City Council to install more shade cloths at the park.
It comes after her partner reportedly tended to a distraught young boy who became “stuck in the boiling sand” at Bob Gamble Park on Monday.
LOWER MERION â The City Avenue Special Services District this week announced that Phase II of its long-term Streetscape and Safety Improvement Program is now complete. The goal of these improvements is to enhance the overall safety and vibrancy along the City Ave corridor, while also creating multi-modal access for pedestrians, bicyclists and people of all abilities.
Phase II work focused on enhancements to pedestrian safety and traffic calming, including the installation of thermal pedestrian detection, critical improvements to crosswalks such as five-second lead intervals for pedestrians, visibly improved stamped crosswalks and solar-powered flashing beacons, and the installation of dynamic speed feedback âSpeedminderâ signs. Stormwater collection and drainage improvements, along with intersection upgrades were also completed.
Powers and Research interchange one of many major road projects on tap for 2021
Here s a breakdown of some of the biggest traffic game-changers we can expect
the Powers and research diverging diamond interchange will break ground this summer
and last updated 2021-01-12 08:42:37-05
COLORADO SPRINGS â As people continue to flock to Colorado, our roads just keep getting more crowded. In response, CDOT has several new highway improvement projects on tap for 2021, including a long awaiting interchange along Powers Boulevard.
âThere are two very large projects coming to the Colorado Springs area,â said CDOT Communications Manager Michelle Peulen.
Those projects include CDOTâs Military Access, Mobility and Safety Improvement project, as well as a new interchange at Powers and Research.