Voluntary consensus standards are developed by national and international bodies and contain methods for classifying objects that are intended to be used as guidelines in the development of products and processes.

The FDA Centre of Devices and Radiological Health (CDRH) has an established programme for recognising standards. A list of consensus standards that CDRH has recognized or decided to recognize is available on the FDA Recognized Consensus Standards Database.

Examples of standard bodies in the medical device industry

• American Society for Testing and Materials(ASTM)
• International Organization for Standardization(ISO)
• International Electrotechnical Commission(IEC)