Still No Definitive Timeline for eMDR Guidance Documents from the FDA

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Back in October 2008, we posted this on our eMDR Updates page on our website:

No definitive release date for eMDR draft guidance documents from the FDA

In a recent Webcast, Indira Konduri of the FDA indicated that they were still working on the proposed rule making for electronic medical device reporting (eMDR). No specific time line has been released. However, she did hint that the time frame to implement (if mandated) would most likely be one year. As with any other proposed guidance, there will be an open public comment period.

Another FDA insider told us that the guidance documents would either be released at the end of this year, or early 2009. Original scheduled release date was 2Q of 2008. We’ll keep you posted as soon as we find out.

According to FDA officials we spoke to a couple of weeks ago, there is still no time-line for releasing the guidance documents to the industry. Apparently, everyone is waiting on the new administration’s leadership team for the FDA to be put in place before proceeding any further. However, considering the significant IT investments that the FDA committed to in 2008, mandating electronic medical device reporting is not a matter of if, but when. We’ll keep you posted.

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