Greetings,
I am currently writing the 510(k) submission for my company, which manufactures a class II medical device that is software (PACS).
I have utilized the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and determined that the Level of Concern is Moderate.
However, according to the FDA's "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices" the Level of Concern is considered to be Minor.
I'm a bit confused regarding what constitutes the proper Level of Concern for a PACS system. Has the FDA changed it's preference regarding the level since the release of the latter guidance document in 2000?
Regards, Tonia
I am currently writing the 510(k) submission for my company, which manufactures a class II medical device that is software (PACS).
I have utilized the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and determined that the Level of Concern is Moderate.
However, according to the FDA's "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices" the Level of Concern is considered to be Minor.
I'm a bit confused regarding what constitutes the proper Level of Concern for a PACS system. Has the FDA changed it's preference regarding the level since the release of the latter guidance document in 2000?
Regards, Tonia