Reports of a 24 percent increase in recalls caused by medtech software may not accurately reflect the scope of the problem or what it means for suppliers, an expert says. The report set off alarm bells throughout the device software industry. The 24 percent recall figure is based on a chart that appeared in the FDA Office of Science and Engineering Laboratories’ 2011 annual report. However, the sources and meaning of the chart were not discussed in the text of the report, making it difficult to tell what’s behind the increase, said David Vogel, president of Intertech Engineering Associates.
Devices & Diagnostics Letter