FDA MedSun Focus Shifts From Recruitment To Educational Outreach
This article was originally published in The Gray Sheet
Executive Summary
FDA says that over the next year it will work to improve the quality and quantity of reports from current Medical Product Surveillance Network (MedSun) participants, rather than recruit more
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Facility inspections increase
FDA's device center exceeded facility inspection goals last year by at least 20%, according to CDRH's 1annual report for fiscal 2006. The agency conducted 1,299 domestic inspections of device firms (1,066 planned), as well as 207 foreign inspections (168 planned) and 336 bioresearch monitoring (BIMO) inspections (278 planned), the report states. The increased number of inspections is part of the center's enhanced postmarket oversight to ensure the safety and effectiveness of products, CDRH Director Dan Schultz says. The document notes that CDRH also exceeded by 15% its 2006 goal of obtaining a 71% participation rate from the 350 health care facilities participating in the Medical Product Surveillance Network (MedSun) (2"The Gray Sheet" July 25, 2006, p. 26)
Facility inspections increase
FDA's device center exceeded facility inspection goals last year by at least 20%, according to CDRH's 1annual report for fiscal 2006. The agency conducted 1,299 domestic inspections of device firms (1,066 planned), as well as 207 foreign inspections (168 planned) and 336 bioresearch monitoring (BIMO) inspections (278 planned), the report states. The increased number of inspections is part of the center's enhanced postmarket oversight to ensure the safety and effectiveness of products, CDRH Director Dan Schultz says. The document notes that CDRH also exceeded by 15% its 2006 goal of obtaining a 71% participation rate from the 350 health care facilities participating in the Medical Product Surveillance Network (MedSun) (2"The Gray Sheet" July 25, 2006, p. 26)
CDRH Tries To Move Adverse Events Into Electronic Age With eMDR Pilot
CDRH will take its first tentative steps towards electronic medical device reporting (eMDR) with a pilot program scheduled to launch this summer