Assessing the Safety and Effectiveness of Devices after FDA Approval

Pew research on U.S. Food and Drug Administration postmarket surveillance studies appeared in the October issue of The Journal of the American Medical Association Internal Medicine. Postmarket surveillance—monitoring the safety and effectiveness of products once they are on the market—allows FDA to more quickly identify problems and accurately measure device performance and clinical outcomes. 

The research found that study protocols frequently were not finalized at the time of approval, which contributes to delays in initiating and completing these studies. Additionally, small sample sizes and lack of availability of findings   limit the clinical usefulness of the studies.

One way to address some of the limitations identified by the authors—including Rita Redberg, a cardiologist at the University of California, San Francisco—is through the wider use of medical device registries, which can quickly and efficiently collect data on large numbers of patients.

Read the full article (subscription required).

Authors: Ian Reynolds, MPH; Josh Rising, MD, MPH; Allan Coukell, BScPharm; Kirsten Paulson, MS; Rita F. Redberg, MD, MSc

America’s Overdose Crisis
America’s Overdose Crisis

America’s Overdose Crisis

Sign up for our five-email course explaining the overdose crisis in America, the state of treatment access, and ways to improve care

Sign up
Quick View

America’s Overdose Crisis

Sign up for our five-email course explaining the overdose crisis in America, the state of treatment access, and ways to improve care

Sign up
Composite image of modern city network communication concept

Learn the Basics of Broadband from Our Limited Series

Sign up for our four-week email course on Broadband Basics

Quick View

How does broadband internet reach our homes, phones, and tablets? What kind of infrastructure connects us all together? What are the major barriers to broadband access for American communities?