FDA MDDS Rule : What you don't know can hurt you

Since the FDA posted it final ruling on MDDS (Medical Device Data System) there has been much concern and down right worry about the effect this ruling will have on entrepreneurial businesses that are trying to make a change in out healthcare systems. I would like to use this blog to gather information to assist others and myself in wading through the quagmire of governmental policy.

Important Notes:
Labeling - If the product is not intended or advertised for connection to a medical device then they shouldn’t have an MDDS. Sort of like tongue depressors with are class 1 Medical Devices. If you take the same Tongue depressor and label it a clay modeling device, then it is not a seen as a Medical Device by the FDA, even though it is the same instrument.

Important dates

· By May 18, 2011 you must register your Medical Device Data System (MDDS) with the FDA

· If your system qualifies as a MDDS, you must be in compliance by Feb. 18, 2012. >>>Download a flowchart that guides you in determining if your system qualifies as a MDDS.

http://www.himss.org/content/files/Flowchart_MDDS.pdf

· If you don’t comply, you could be subject to financial penalties

Here is the link to the HIMSS FDA Webinar on MDDS.

Replay the HIMSS Webinare Listen to the webinar >>

Please join in,

Jeff Brandt

PLEASE NOTE: I am not a lawyer and provide no legal opinion of the FDA or it's regulations. I am providing this information for a topic of discussion. I suggest that you contact legal representation on determining more information on MDDS and Medical Devices.