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Medical Devices / Regulatory Affairs

FDA Drops Proposed Rule on Electronic Labeling

Nov. 2, 2018

The FDA withdrew a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices.

The FDA had previously determined that class II and class III devices are at higher risk of misuse due to misplaced labeling and operating instructions. Under the proposal, device information would have been uploaded to a database and made available to the public.

According to AdvaMed, an online medical device labeling database poses numerous problems, “including risk to patient safety due to the frequency at which patient labeling may be updated.”

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