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‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October

 
• By Hannah Daniel

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

• Source: Shutterstock

Beginning on 1 October 2023, the Food and Drug Administration will refuse to accept premarket submissions that do not include information from the cybersecurity amendments of the Food, Drug and Cosmetic Act.

The FDA will allow sponsors a grace period from the enactment of the amendments—today, 29 March—until 1 October, where it will not issue RTAs for premarket submissions that do not

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