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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
A federal grand jury indicted Theranos CEO Elizabeth Holmes and COO Ramesh Balwani on two counts of conspiracy to commit wire fraud and nine counts of fraud. Read More