510(k) Timing from Submittal to FDA Approval

[DirteJoe]

Please see the presentation from annual AMDM presentation given by Alberto Gutierrez...

 

[J0anne]

ENCLOSURE

MDUFA PERFORMANCE GOALS AND PROCEDURES

The performance goals and procedures of the FDA Center for Devices and Radiological
Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), as agreed
to under the medical device user fee program in the Medical Device User Fee
Amendments of 2007, are summarized as follows:
I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2008 THROUGH 2012 AS
APPLIED TO RECEIPT COHORTS

All references to "days" mean "FDA days."

A. ORIGINAL PREMARKET APPROVAL (PMA), PANEL-TRACK PMA
SUPPLEMENT, AND PREMARKET REPORT SUBMISSIONS
FDA will issue a decision for 60% of non-expedited filed submissions within 180
days, and for 90% within 295 days.

B. EXPEDITED ORIGINAL PMA AND PANEL-TRACK PMA SUPPLEMENT
SUBMISSIONS
FDA will issue a decision for 50% of expedited filed submissions within 180
days, and for 90% within 280 days.

C. PMA MODULES
FDA will take action on 75% of PMA modules within 90 days, and on 90%
within 120 days.

D. 180-DAY PMA SUPPLEMENTS
FDA will issue a decision for 85% of 180-day PMA supplements within 180 days,
and for 95% within 210 days.

E. REAL-TIME PMA SUPPLEMENTS
FDA will issue a decision for 80% of real-time PMA supplements within 60 days,
and for 90% within 90 days.

F. 510(K) SUBMISSIONS
FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within
150 days.

http://www.fda.gov/downloads/Medica...serFeeandModernizationActMDUFMA/UCM109102.pdf