EPISODE 2: Product Recalls, Including Removals and Corrections

#medicaldevice #regulatory #FDA #recalls

What steps do medical device manufacturers need to take if they have to notify FDA and consignees about a product recall, and what specific information is used to evaluate the recall?

In this episode of "FDA Guidance Review," medical device regulatory affairs expert and former FDA staffer David Pudwill discusses these topics, and provides helpful hints based on his years of experience, in a review of the March 2020 Guidance Document: “Product Recalls, Including Removals and Corrections.” Note that as a broad Guidance, it covers products including medical device, drugs, biologics, and others, and thus impacts a number of centers within FDA.

Here are 3 Key Takeaways that David would like viewers to understand from this video:

1. What recall information is submitted to FDA?
2. What recall information is sent to consignees/end-users?
3. What information is used to evaluate the recall?

Guidance Document on the FDA website: https://www.fda.gov/regulatory-inform...

Guidance Document PDF: https://www.fda.gov/media/136987/down...

David’s easy-to-follow Guidance review provides clarity and context to those currently working in regulatory affairs, those aspiring to enter this important field, and anyone across healthcare with an interest in the device regulatory process.

With each episode in David Pudwill’s "FDA Guidance Review" video series, stay on top of FDA's evolving policies, and learn how to engage effectively with the agency - both being critical to the success of your medical device regulatory strategy.

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