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FDA Offers Draft Guidance For Developers Of Drug Delivery Devices

 
• By Brian Bossetta

The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.

Insulin Pens
• Source: Shutterstock

The Food and Drug Administration’s draft guidance — “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products” — seeks to help developers of devices that deliver drugs achieve essential drug delivery outputs (EDDO) to ensure the optimal performance of their products.

EDDOs, the FDA says, are necessary to ensure devices designed to deliver drugs accurately deliver the correct dose to the...

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