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News Briefs: Device Tax Repeal Momentum; J&J Settles Hip Suit; Mobile Medical Apps Bill

This article was originally published in The Gray Sheet

Executive Summary

Device tax repeal momentum. Johnson & Johnson/DePuy has settled a lawsuit from a California plaintiff related to injuries from the ASR hip implant. Rep. Marsha Blackburn is working on legislation to clarify FDA’s authority over mobile health apps. Zimmer will market Frontier’s Lateral Locking Cage. More news.

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Despite being a factor in lawmaker discussions throughout the shutdown, provisions to delay or repeal the device tax did not survive in the final agreement to reopen the federal government and raise the debt ceiling. But the issue appeared to gain more momentum than ever that companies hope can be maintained into upcoming budget conference talks.

Device Tax Repeal Gains High Profile During Shutdown, But Significant Barriers Remain

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In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.

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