Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
MD&M East

Validating Software as a Medical Device (SaMD)

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
RAPS

Medical device software regulations in the EU and US

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.
Nature

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway

Medical devices have played a critical role in raising the standards of healthcare delivery. The COVID-19 pandemic underscored clinical medicine’s dependence on devices ranging from diagnostic test ...
Nature

FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges

FDA approval is widely regarded as a benchmark of quality for medical devices. However, concerns persist regarding its regulatory framework for digital mental health devices. This perspective article ...
JD Supra

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series ...
ISA

Focus on HART Devices and Software

The 154 HART calibration assistant is a standalone tablet-based communication tool for HART configuration. The 154 provides HART communication functionality. When combined with a 750 series ...