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Expert: FDA Missed Opportunity For Software In Remanufacturing Guidance

 
• By Hannah Daniel

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

• Source: Shutterstock

The US Food and Drug Administration’s guidance on medical device remanufacturing does not adequately address device software, Brooke & Associates medical device attorney Jason Brooke said.

Brooke told Medtech Insight the FDA “missed [the] opportunity to discuss this topic for software products.”

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