Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

2.5.2.3 FDA Standards

The FDA maintains a list of recognized consensus standards on their web site,^P which includes standards from IEC, ISO, and other organizations. Manufacturers and assemblers of systems use these standards to demonstrate that a product is safe and effective. Depending on the classification of the equipment (see Section 2.5.1), supporting evidence of compliance to the applicable performance standards may need to be submitted to the FDA for review and approval.

Notably, among the FDA’s recognized consensus standards is ANSI/AAMI HE 75,^Q recommended practices for human factors design principles for medical devices. Chapter 16 of ANSI/AAMI HE 75 contains recommended practices regarding accessibility for patients and health care personnel with disabilities.

For radiation emitting devices (such as some diagnostic imaging equipment), FDA has a set of performance standards that focus on radiation safety to the operator and patient. These are found in the Code of Federal Regulations, specifically in Title 21, Part 1020 (21 CFR 1020), Performance Standards for Ionizing Radiation-Emitting Products, and Part 1050 (21 CFR 1050), Performance Standards for Sonic, Infrasonic and Ultrasonic Radiation-Emitting Products. Manufacturers and assemblers of applicable systems must file a report to FDA that includes test data that demonstrates compliance to the applicable performance standards for the device in question.

Notes

^P This list of consensus standards recognized by the FDA is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

^Q Information about the human factors design principles for medical devices is available at: http://www.aami.org/he75