FDA plans to increase post market medical device surveillance even further though the implementation of four adjustments to the current program. The FDA report entitled, “Strengthening our National System for Medical Device Post Market Surveillance” lists the fundamental changes by the FDA. The changes can be found verbatim here.
To increase the existence of post marketing follow up, FDA is attempting to come up with a unique device identification system. Essentially, under the UDI system each medical device contains a code that links it to “the model and a production identifier that would have current manufacturing information.”* Also, the system protects the privacy of patients by not allowing any personal patient information to be part of the UDI.
Although FDA has been in the process of getting the concept approved since 2009, UDI’s are finally gaining recognition. The system has many advantages including simplifying the tracking process if devices happen to be recalled and “searchable database will be available to the public.”*
Need assitance on any post marketing follow up? Contact us at email@example.com
To submit feedback to the FDA on unique device identifcation systems click here.
To read more on this topic, check out this DrugWatch article by clicking here.