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 ...
Medical News Today

What to know about the different types of crutches

The three main types of crutches are axillary, forearm, and platform. The type a person requires will depend on their needs and physical capabilities, as each assists movement in different ways.
RAPS

FDA Moves Three Device Types into Class II Special Controls

The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...
News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...