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Software Pre-Certification Program Highlights Needs For Legislative Change, FDA Says

 
• By Hannah Daniel

In a report published September 26, the FDA released the findings from its software pre-certification program which include the need for a new regulatory authority to supplement current regulations for medical devices.

• Source: Shutterstock

Software used as a medical device (SaMD) needs a new regulatory authority that would require legislative change, the Food and Drug Administration reports in a new document detailing findings from its 2017 Software Pre-Certification program.

The new authority would not replace the current regulatory framework. Instead, it provides supplementary guidelines to keep up with a...

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