FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints

SGquality

Quite Involved in Discussions
Could you tell me the relation between the different FDA terms - FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complaints ?
 

Ronen E

Problem Solver
Moderator
Re: FDA terms - Adverse Events, Medical Device Reporting, MAUDE and Customer Complain

Hi,

For understanding Adverse Events and Medical Device Reporting (MDR) look at

http://www.fda.gov/MedicalDevices/D...ostmarketRequirements/ReportingAdverseEvents/

MAUDE = Manufacturer and User Facility Device Experience

MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

To understand FDA's approach to handling customer complaints look at

http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122686.htm

Anything else, just let me know.

Cheers,
Ronen.
 

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