Product validation and verification: The information provided in the product validation and verification section of the device master file will vary in the level of detail as determined by the class of the device. The device master file should summarize the results of validation and verification studies undertaken to demonstrate conformity of the in vitro diagnostic medical device with the essential principles that apply to it. Where appropriate, such information might come from literature. For the purpose of the device master file document, summary and detailed information are defined as follows: (i) Summary information: A summary should provide enough to assess the validity of that information by the regulatory authorities. This summary should contain a brief description of: (a) the study protocol; (b) the study results; (c) the study conclusion. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 121 of 248 This summary may include: (a) Where a recognized standard exists, a eclaration/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.