1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

FDA Review Trends: Original PMAs Up, 510(k)s Down So Far In 2015

The overall volume of agency approvals and clearances has been relatively steady from last year to this year. The biggest spike so far is in original PMA approvals.

FDA approved 13 original PMAs so far in 2015, almost twice as many as it approved during the first four months of last year. Meanwhile, 510(k) clearances- have declined slightly compared to last year.

The increase in original PMAs, from a total of seven approvals from January through April 2014, is mostly due to decisions made in the past two months. Four applications each...

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
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.