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The FDA published a draft guidance on Medical Device Reporting for Manufacturing on Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements – Draft Guidance for Industry and Food and Drug Administration Staff.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.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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