A
The gist is this.
Guidance is posted here. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm
The FDA does not intend to enforce compliance with the regulatory controls that apply to the following devices:
- MDDS subject to 21 CFR 880.6310,
- Medical image storage devices subject to 21 CFR 892.2010, and
- Medical image communications devices subject to 21 CFR 892.2020.