Original Medical Device Premarket Applications Approved by the FDA

Notes: Applications were counted according to the fiscal year in which the application was received by FDA, even if an approval or another decision occurred in a subsequent fiscal year.
a Applications with a decision other than approved may include applications that reached a “not approvable” decision or were otherwise withdrawn.

Data Source: GAO analysis of Food and Drug Administration (FDA) data.

Source: U.S. Government Accountability Office: FDA Medical Device Reviews: Evaluation is Needed to Assure Requests for Additional Information Follow a Least Burdensome Approach