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.
· 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.