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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
Participants in the pilot program agreed to provide information on how they develop, test and maintain their software products and on their quality management systems. They also committed to being available for site visits from agency officials. Read More
“The improper influence Stryker allegedly brought to bear increased the cost of devices as well as the number of devices implanted and surgeries performed,” which association members had to pay for, court documents said. 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