This summary may include: (a) Where a recognized s...

This summary may include: (a) Where a recognized standard exists, a declaration/certificate of conformity to a recognized standard can be provided with a summary of the data if no acceptance criteria are specified in the standard; (b) In the absence of a recognized standard, a declaration/certificate of conformity to a published standard that has not been recognized might be provided if it is supported by a rationale for its use, and summary of the data, and a conclusion, if no acceptance criteria are specified in the standard; (c) In the absence of a recognized standard and non-recognized published standards, a professional guideline, industry method, or inhouse standard may be referred to in the summarized information. However, it should be supported by a rationale for its use, a description of the method used, a summary of the data in sufficient detail and a conclusion to allow assessment of its adequacy; (d) A review of relevant published literature regarding the device / analyte (measurand) or substantially similar in vitro diagnostic medical devices.