Regulatory Open Forum

Hi Everyone,

I am sure most of you have received the FDA's letter stating they are extending UDI requirements for Class I medical devices to 2020 (other than life supporting, life sustaining devices which should already be in compliance) and Direct Marking on Class I devices to 2022! I have attached their letter if for some reason you have not received it.

Happy Friday! :)

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Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
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Thanks Lauren!

Shared this with the team :)

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Joshua Lust
Global Regulatory Affairs Manager
Aspen Surgical
Hopkins MI
United States
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Original Message:
Sent: 02-Jun-2017 11:30
From: Lauren Combs Viker
Subject: UDI Class I extension

Hi Everyone,

I am sure most of you have received the FDA's letter stating they are extending UDI requirements for Class I medical devices to 2020 (other than life supporting, life sustaining devices which should already be in compliance) and Direct Marking on Class I devices to 2022! I have attached their letter if for some reason you have not received it.

Happy Friday! :)

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
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