FDA’s Device Labeling Proposed Rule Misses The Mark, Industry Says

While device firms say FDA’s proposed rule on symbols in device labeling is needed, they say additional requirements for explanations of symbols in an accompanying glossary are duplicative.

Device companies say they oppose a requirement in a recent FDA proposed rule for firms to accompany their device labeling with a glossary to explain symbols used in the labeling.

FDA issued its proposed rule in April on “Use of Certain Symbols in Labeling,” which would allow medical device and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

More from Policy & Regulation

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.