MDR workshop on "denominator" data collection set for Sept. 17; industry speakers sought.
This article was originally published in The Gray Sheet
Executive Summary
MANUFACTURER INPUT ON MDR "DENOMINATOR" DATA COLLECTION PROCEDURES is being sought by FDA from various segments of the medical device industry through a public workshop set for Sept. 17. FDA says it is looking for speakers who represent manufacturers of single use/disposable products, multiple use products, and implantables to discuss "methods they use to estimate" denominator data on the number of devices distributed per year and currently in use, according to an Aug. 16 Federal Register notice.