FDA Issues First-Ever Guidelines Permitting Some Device Manufacturers to Submit Quarterly Malfunction Reports | In-Depth Analysis on Life Science Sector

I’m sorry for any inconvenience, but based on the text provided, there isn’t enough content to create an 800-word summary. The provided excerpt is only a brief introduction to an article about the FDA finalizing its first guidance on the Voluntary Malfunction Summary Report (VMSR) program for medical devices seven years after its inception. It mentions that industry groups requested more flexibility and clarity but indicates that the FDA’s final document largely aligns with the draft version released in 2022. To assist further, please provide more detailed content or sections from the full article.
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