Protect patient’s safety from the inherent dangers of medical devices

21USC gives the FDA authority over radiation emitting electronic devices. FDA has promulgated several performance standards for such devices as x-ray and lasers. These standards require manufacturers to provide instructions upon request to anyone to assure the safety of these devices. The FDA also has manufacturer's requirements for instructions for the safe installation of all devices. Despite the guidance efforts of the FDA some manufacturer's refuse to comply or create barriers to requests for instructions such as licensing or passwords. All efforts to resolve these issues with the FDA have failed.
In order to protect patient safety we request a final, complete, lasting resolve of the issues reported to the FDA, including 21CFR instructions for 1020.30g,h, 1040.10h-11, and 820.170a,b.