In a press release Bakul Patel, director of the FDA’s Digital Health center, stated:
“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”
The draft guidance pertains to software in a medical device (“SiMD”) and software as a medical device (“SaMD”). The Regulatory Affairs Professional Society (RAPS) describes SiMD as “software that is a part of a medical device or controls it” and SaMD as “software that meets the definition of a device but is not part of the overall device’s hardware.” According to the FDA, both SiMD and SaMD are “device software functions.”
The draft guidance is intended to cover: firmware and other means for software-based control of medical devices, stand-alone software applications, software intended to be operated on general-purpose computing platforms, dedicated hardware/software medical devices, and accessories to medical devices when those accessories contain or are composed of the software.
Portions of the draft guidance to consider include the software device documentation and software risk management requirements. Software may require a basic or enhanced level of documentation, depending on risk to a patient, user, other individual, or environment. A risk assessment and risk management plan may be required.
PORTLAND, Ore. – November 4, 2021 – SensiML™ Corporation, a leading developer of AI tools for building intelligent Internet of Things (IoT) endpoints, today announced that it has teamed with onsemi to deliver a complete machine learning solution for autonomous sensor data processing and predictive modeling. The collaboration combines SensiML’s Analytics Toolkit development software with the RSL10 Sensor Development Kit from onsemi to create a platform ideal for edge sensing applications such as industrial process control and monitoring. SensiML’s ability to support AI functions in a small memory footprint, along with the advanced sensing and Bluetooth® Low Energy connectivity provided by the RSL10 platform, enables sophisticated smart sensing without the need for cloud analytics of highly dynamic raw sensor data.
Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger […]
Today on Fintech, we are please to speak to Vinny Yu and Jeff Tsai, Co-Founds of JAVLIN Invest. JAVLIN Invest is the only portfolio optimization app to provide both risk-return portfolio optimization and the ability to project long-term risk-return based on potential macroeconomic conditions. Leveraging machine learning and sophisticated risk models, JAVLIN Invest offers self-directed […]
Before we head towards the concept of a cannabis tolerance break, let’s first understand what is a tolerance. Tolerance is a state when a body becomes resistant to a medication or any substance when consumed on a regular basis. The tolerance leads to a stage where an individual requires a higher dosage of the substance …
Anthony Arundel, co-author of Harnessing public research for innovation in the 21st Century: An international assessment of knowledge transfer policies, discusses the main gaps in our understanding of how knowledge transfer works and key considerations for policymakers in crafting effective knowledge transfer policies for the future.
Is it time to fly again? It’s a decision we all need to make for ourselves. But as COVID rates downtrended in some parts of the world, and with at least a chunk of the population vaccinated, this summer felt like the right moment for me. And I took advantage with a long-haul itinerary from […]