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September 2009

eMDR and Event Problem Code Changes: Are We There Yet?

Normally, "are we there yet?" is the annoying question kids, and some adults, ask during a drive to a summer vacation spot. As summer comes to an end, "are we there yet?" is also a good question for your company to consider with regard to two initiatives currently underway at FDA: eMDR and Event Problem Code changes.

So where are we with respect to eMDR? At present, there are currently more than 30 device manufacturers submitting electronic MDRs to FDA via the FDA eSubmitter (low volume) option and six device manufacturers submitting MDRs via the HL7 (high volume) option. The regulation that will mandate electronic submission of MDRs is imminent. It is expected that once the regulation is published, device manufacturers will have approximately one year to implement the requirements of electronic reporting of MDRs into their systems. Once the implementation phase is complete, paper copies will no longer be accepted by FDA, so you want to act early to avoid compliance problems in the future.

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Writing and Maintaining SOPs: Drudgery or Delight

"SOPs! We don’t need no stinking SOPs!” This is how many companies feel when asked about their standard operating procedures (SOPs). They may think they don’t need the proper documentation to do a good job. What companies fail to understand is that working without SOPs is becoming increasingly impossible—and even dangerous—in the world of regulated industry.

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Did you know that inspections of medical device facilities have already started to rise as funds set aside for the FDA have increased under the Obama administration? The need for these inspections, according to a recent article from FDANews, has led the agency to hire 450 inspectors to address device inspections as well as those inspections required within the drug and food industries.
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