FDA Issues New PMA Guidance as a Part of MDUFA III Agreement
Thursday, October 18, 2012
While FDA began collecting updated user fees for PMAs earlier this
month, new guidance detailing PMA submission and approval was issued
this week. The changes in guidance are designed to speed up the review
process and meet goals set by the agency. By 2017, FDA hopes to be
meeting performance goals 90% - 95% of the time.
"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.
Some changes include:
- Pre-application reviews
- Shared outcome goals
- Formulation of "Missed MDUFA Decision" notices
MDMA is following the implementation of MDUFA III very closely as
well as working with Members of Congress as they address sequestration
and appropriations for the FDA.
To read the full guidance document, please click here.