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.”
WOLHUSEN, Switzerland (BUSINESS WIRE) Geistlich Pharma, a Swiss developer of biomaterials for regenerative therapies in orthopedics, announced that the Chondro-Gide® articular cartilage cover has been granted a Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration. Chondro-Gide® is a col.
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Pedra Tissue Perfusion System Receives FDA Breakthrough Device Designation
Novel perfusion monitor allows real-time, periprocedural monitoring of tissue perfusion in patients with critical limb threatening ischemia
The Pedra Blood Perfusion Index tracks real-time changes in foot tissue perfusion attendant with balloon inflation and deflation during an angioplasty procedure.
January 26, 2021 Pedra Technology, a privately held company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for the periprocedural use of its Pedra Xauron Perfusion System in the treatment of critical limb threatening ischemia (CLTI).
CLTI is a severe form of peripheral artery disease (PAD) that is defined as ischemic rest pain, tissue loss, or gangrene (tissue death) that develops as a result of chronically poor blood flow to the lower limbs. If left untreated, CLTI can lead to limb amputation or death. The 1-year mortality rate o
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Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited.
To start off the new calendar year, FDA issued a revised version of its guidance document on the Q-submission program on January 6, 2021, “
Obtaining feedback on submissions that may qualify for FDA’s recently announced Safer Technologies Program (STeP), also launched on January 6, 2021 (see
Guidance Document). The STeP Program provides an expedited review and authorization process for certain device 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 wit