|2004N-0527||Medical Devices; Medical Device Reporting|
|FDA Comment Number :||EC5|
|Submitter :||Mrs. Tammy Foust||Date & Time:||05/26/2005 11:05:38|
|Organization :||Respironics, Inc.|
|Category :||Device Industry|
| Sec. 803.20(c)(1)
We believe that this section would be burdensome to a corporation and that it is referencing the "per se" rule that is no longer in effect. The manufacturer should be able to perform an investigation on the event or malfunction which includes gathering information from the user facility as well as utilizing their (the manufacturer's) internal experts which includes medical professionals. There is a person qualified to make medical judgments within our corporation who is regularly involved with MDR reporting decisions. It is unclear if FDA is proposing that information a manufacturer receives from a user facility that "reasonably suggests" an event occurred MUST take the word of the user facility or if the manufacturer is permitted to utilize their experts in determining if an event actually occurred.