Metric

FY01

FY02

FY03

FY04

Total elapsed time

376

356

357

290

FDA review time

283

283

271

271


Table III. Average FDA review time and average total elapsed time, from filing to approval, for all original premarket approval (PMA) applications and panel-track PMA supplements (excluding withdrawals), FY01–FY04. Source: FDA Office of Device Evaluation.