Скачать или смотреть EPISODE 5: Unique Device Identification Compliance Dates

#medicaldevice #regulatory #FDA #UDI #COVID19

On June 30, 2020, FDA issued an immediately-in-effect Guidance on its policy regarding unique device identification (UDI) and other compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. In this episode of "FDA Guidance Review," medical device regulatory affairs expert and former FDA staffer David Pudwill discusses this July 2020 Guidance Document: “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” David walks the viewer through FDA’s position, noting that due to implementation issues, the COVID-19 public health emergency and other factors, the agency does not intend to enforce certain UDI Rule requirements before September 24, 2022—in effect giving sponsors a reprieve from previously stated deadlines.

Here are David’s 3 Key Takeaways that he would like viewers to understand from this video:
1. What is a UDI?
2. What is FDA's policy on Global Unique Device Identification Database (GUDID) submission?
3. What are the compliance dates for UDI?

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

Guidance Document PDF: https://www.fda.gov/media/110564/down...

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