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A Look Ahead: US FDA And Medical Device Regulations In 2021 | Lowenstein Sandler LLP

Med Device Online - March 10, 2021
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote inspections, and what accommodations should be made for clinical trials disrupted by COVID-19. On top of that, FDA found itself facing an enormous and unprecedented amount of political pressure, with its actions, or lack thereof, potentially altering the presidential election. Yet through it all, the agency continued to largely fulfill its core responsibilities of ensuring compliance and helping to bring new products to market, including, for example, approving by its own reckoning 132 novel medical devices, a significant increase over 2019. Now that we are in 2021, what big developments can we expect from FDA in general and regarding medical devices in particular? This article explores some of the FDA initiatives and activities wor ....

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A Look Ahead US FDA And Medical Device Regulations In 2021

Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article. ....

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With Release Of New Guidance Document FDA Launches Safer Technologies Program for Medical Devices

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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FDA Opens the Pre-Sub Program to Compliance Actions, Including Form 483s and Warning Letters | Morgan Lewis

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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 ....

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FDA Issues Final Guidance on the Safer Technologies Program (STeP) for Medical Devices | Manatt, Phelps & Phillips, LLP

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On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal of expediting development and FDA review of medical devices or device-led combination products that are likely to offer safer treatment or diagnosis of certain diseases and conditions as compared to currently available alternatives. Such alternatives may include currently marketed medical devices or other standard care practices, such as use of FDA-approved drugs and biologics. ....

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