POSTMARKET SURVEILLANCE STUDIES WOULD BE LIMITED TO 18 MONTHS UNDER HOUSE FDA REFORM MEASURE; MALFUNCTION REPORTING REQUIREMENTS ALSO CURTAILED
This article was originally published in The Gray Sheet
Executive Summary
Rep. Joe Barton's (R-Tex.) medical device FDA reform bill (HR 3201) would limit the duration of FDA-ordered postmarket surveillance studies to 18 months. Under current law, there is no limit on the length of PMS studies. PMS study length also is not addressed in Sen. Nancy Kassebaum's (R-Kan.) FDA reform bill (S 1477).