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Genus Triumphs Over FDA In Barium Sulfate Product Classification Suit

 
• By Elizabeth Orr

The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.

Periodic symbol for barium on a silver square
• Source: Shutterstock

A contrast agent used during radiology scans is legally a device and not a drug, the DC Circuit Court of Appeals determined on 16 April in a rebuke to the US Food and Drug Administration.

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More from Regulation

Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

EU Harmonized Standards Continue To Trickle In Under MDR

 
• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

More from Policy & Regulation

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.