News & Press: Latest News

FDA Issues 2013 User Fee Rates

Thursday, August 02, 2012  
Share |

FDA this week released the user fee rates for 510(k) and PMA submissions in 2013. The new user fees are a part of the MDUFA reauthorization that was signed into law last month and capped nearly two years of negotiations between FDA and various stakeholders.

Included in the reauthorization are new rigorous guardrails designed to improve performance such as "total time" goals for regulatory review, as well as "no submission left behind" policies to ensure regulators are clearly and consistently communicating with businesses about their submissions.

The new fee structure also includes discounted rates for small medical device companies, and potential waivers for one's first PMA submission if the company has less than $30 million in gross sales and receipts.

MDMA is working with FDA and elected officials to ensure that the commitment letter that was included in MDUFA reauthorization is honored to help ensure that the regulatory pathway is more predictable and transparent.

To view the user fee rates for 2013, click here.