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Medical Device, News | October 30, 2012

FDA to Speed Device Approval Process

This year has been somewhat up and down for medical device developers. The medical device excise tax was approved, and any devices sold starting in 2013 will be subject to this 2.3% tax. Most device developers agree that this will have negative consequences for the medical device market.

However, there is positive news, as the FDA seems to be committed to improving the path to market for medical devices. Not only is the FDA expressing a desire to improve industry relations with the newsest version of the Medical Device User Fee Act (MDUFA), but the FDA has now released a guidance document stating the goal of reducing the average 510K approval times.

Speedier Approvals by 2017

By 2017 the FDA has committed to reducing the average approval time to 124 days, down from an average of 150. Additionally, a goal for fiscal year 2012 is to process 90% of decisions within a 90 day window.

While not a significant overall decrease in average approval time, it is important to note that the vast majority of submissions will be processed more quickly – and by 2017 the aim is that 95% of submissions will be processed in that 90-day time window. We certainly support efforts that help devices get to those who can benefit from them more quickly, and hope that the FDA contiunues to improve their approval times.

For more information, please visit the FDA web site and their 510k guidance documents.

FDA Guidance for Industry – 510k Submissions

Pacific BioLabs