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  5. Manufacturer Certification Programs
  1. IVD Regulatory Assistance

Manufacturer Certification Programs

FDA encourages manufacturers to have their devices tested and certified when and appropriate certifying body exists.

Total Cholesterol, HDL Cholesterol, and LDL Cholesterol

The Cholesterol Reference Method Laboratory Network (Centers for Disease Control and Prevention) provides information on manufacturer certification programs for total cholesterol, HDL cholesterol, and LDL cholesterol. It includes lists of analytical systems that are certified by the Cholesterol Reference Method Laboratory Network (CRMLN) as having documented traceability to the national reference system for cholesterol.

Conforming Products for Evidential Breath Testing and Alcohol Screening Devices

The Department of Transportation’s (DOT) rule, 49 CFR Part 40, describes required procedures for testing of Evidential Breath Testing Devices and Alcohol Screening Devices to meet DOT's specifications.

Hemoglobin A1C Certification program

The purpose of this program is to standardize glycated hemoglobin test results so that clinical laboratory results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established. A key component of the program is the Reference Laboratory Network. The network interacts with manufacturers of GHB methods to assist them first in standardizing their methods and then in providing comparison data for certification of traceability to the DCCT.

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