The Dreaded Performance Appraisal – How the FDA Is Doing with Medical Devices and the Medical Device Industry
Calisha D. Myers, Esq., Staff Writer for Life Science Compliance Update
The FDA and the GAO both released data on the FDA’s performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA’s OpenFDA database. The data shows recalls have increased, but postmarket and postapproval studies have declined.