Report Says FDA Significantly Reduced Medical Device Review Times

August 31, 2015

Earlier this year, FDA published a report announcing that the Agency’s device program has shown “a pattern of markedly improved performance.” Over the past five years, FDA has been working to improve approval times for medical device submissions using the Medical Device User Fee act. The report goes on to say that all three areas have seen a reduction in review times, however IDE review times have been reduced by more than a full year, allowing medical devices to reach the market much sooner than they would have just a few years ago.

With approval times getting increasingly longer, many companies were beginning to relocate overseas or market their devices abroad before introducing them in the US. The reason for this? The FDA did not have the necessary resources and funds to get through all of the applications at a faster pace. The solution? FDA’s Medical Device User Fee program.

FDA states that approval times have been reduced for the following device submissions:

  1. 510(k) times were reduced from 132 days in 2010, to 115 days in 2014 (or 13%).
  2. PMA times were down to about 242 days in 2014 from 352 days in 2009 (or 31%).
  3. De novo requests were reduced from 992 days in 2010 to just 300 days in 2014 (or 70%).
  4. IDE decision times showed the most drastic improvement, being reduced by more than a year, from 442 days in 2011 to just 30 days in 2015 (or 93%).

As the numbers show, the Medical Device User Fee program is clearly doing what it was intended to do, reducing the approval times for medical devices. Because of this program, FDA has the resources needed to come to decisions in a more timely manner, getting devices to the public faster.

Although their program is making amazing progress, ensuring you are submitting the correct application for your product can be a daunting task. That’s why we’re here to help. We take a unique approach, which combines an extensive scientific knowledge with a deep understanding of the regulatory environment to bring you the desired approval from the Agency. To learn more about how we can help get your product to market faster, please contact us.

Medical Devices Agency Alerts

February 28, 2019

Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment

On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...

Read the Full Article
Medical Devices Agency Alerts

September 19, 2018

FDA Considers Moving Medical Device Submissions to Electronic Format

On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...

Read the Full Article
Agency Alerts General Regulatory

March 25, 2016

Senate Bill Would Change How FDA Reviews & Regulates Medical Devices

On March 17, 2016, the Improving Medical Device Innovation Act was introduced in the Senate’s Health, Education, Labor, & Pensions (HELP) committee. The bill, championed by Senators Amy Klobuchar (D...

Read the Full Article