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Industry Experts Give FDA’s Pre-Cert Program Thumbs-Up

 
• By Brian Bossetta

A panel of industry experts gave the US FDA’s Digital Software Precertification Program the thumbs-up during a MedCon session.

FDA Shadow
• Source: Alamy

When the US Food and Drug Administration introduced its Digital Health Software Precertification (Pre-Cert) in 2017, the idea was to create a streamlined process for more efficient regulatory oversight of software-based medical devices.

To achieve this, the FDA would allow manufacturers of these devices to update the software without having to submit the required premarket 510(k) submissions if certain conditions are met

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