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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. 14. Judge Rosemary Collyer of the U.S. District Court for...

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