FDA Distinguishing Recalls from Enhancements Draft

The FDA published a draft guidance on Medical Device Reporting for Manufacturing on Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements – Draft Guidance for Industry and Food and Drug Administration Staff. This guidance is structured as a series of questions and answers and is at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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