Federal regulators issued new guidelines for medical device makers seeking pre-market approval under the FDA’s new user fee program.
The FDA’s Center for Devices & Radiological Health this week issued new guidance on how the agency hopes to hit the goals for medical device review that were agreed to in the latest generation of the Medical Device User Fee & Modernization Act.
All eyes are on CDRH to ensure that it makes good on the deals it signed with the medical device industry in exchange for a hike in the fees companies pay for agency review. Some members of Congress have even called for the FDA to provide quarterly reports on progress toward meeting those time-lines.
The new MDUFMA agreements allow federal regulators to begin collecting the increased PMA fees beginning this month, according to guidance documents.
"The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process," the agency wrote.
The new user fees set decision goals as follows:
|Original PMAs and Panel-track Supplements without panel||180 days|
|Original PMAs and Panel-track Supplements with panel||320 days|
|180-day Supplements||180 days|
|Real-time Supplements||90 days|
All goals are defined in "FDA days," which includes only the time that the application spends awaiting agency action and does not include periods during which the FDA is waiting for additional information or action from the applicant.
The FDA hopes to get progressively better at reaching those goals, aiming to hit its time-lines with 90%-95% consistency by fiscal year 2017.
Some of the performance goals and associated changes under the new user fee agreements include:
- Pre-application review for original PMAs and panel-track supplement PMAs
- A shared goal for total time from application submission to decision
- "Missed MDUFA Decision" notices for companies whose reviews have missed goals by 20 days.