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One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe. Read More
The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety. Read More
The FDA put out a list of alternative ways to comply with quality system requirements for device combination products, making suggestions for design controls and quality system regulation exemptions. Read More
The FDA finalized guidance on medical product communications that are consistent with FDA-required labeling, presenting a three factor test to determine whether a communication is consistent with labeling requirements. Read More
The new requirements address labeling, shelf life and temperature requirements as well as general requirements for registering devices and IVDs in Saudi Arabia. Read More
The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5997) would require Medicare to cover all breakthrough products that are approved through the FDA’s expedited review process for three years. Read More