Standards

The submitter should identify any mandatory or voluntary standards met by the device, citing each by paragraph or requirement. Although a device need not meet any particular standard, if substantial equivalence is being claimed to one or more predicate devices that do meet a given standard, then the new device should also meet it. Except for certain radiation-emitting devices, FDA has no mandatory standards, and relies heavily on those accepted by the industry and on its own guidance documents with their standard-like requirements.118