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Ball In Judge’s Court In Combination Product Classification Suit

All the planned briefs have been filed in a case, Prevor v. United States Food and Drug Administration, that could have important implications for how FDA designates a product for either device or drug primary review.

Parties are awaiting a decision from a federal court judge on a case that could have a significant impact on whether certain combination products are designated for FDA review as a medical device or are subject to the more demanding drug review process.

FDA filed the case’s last planned brief in Prevor v. United States Food and Drug Administration on Feb....

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