FDA. In vitro diagnostic products (IVDs), are those reagents, instruments, and systems intended for use in the diagnosis of disease or other ailments including a determination of the state of health, in order to cure, treat or prevent disease. These products are for use in the collection, preparation, and examination of specimens taken from the human body. This guideline applies to clinical chemistry and clinical toxicology devices, hematology and pathology devices, and immunology and microbiology devices. The guideline supplies general guidance on the application of the medical device good manufacturing practice (GMP) regulation, CFR Part 820, to processes typically followed in the manufacture of IVDs. It captures methods and procedures for meeting requirements of the medical device GMP regulation. It also provides general guidance on the application of the labeling regulation, for these devices. This guideline is used as a reference by FDA investigators while performing GMP inspections of manufacturer's facilities. When manufacturers decide not to implement this guideline, FDA expects that their choice of procedures and processes will be equivalent to ensure the safety and effectiveness of their IVDs. This guideline has been issued to address several areas concerning the application of the GMP regulation to IVDs. This guideline is an effort to reduce instances of failure to comply with the GMP regulation as reflected in FDA's experience with legal actions and recalls. The importance of GMP compliance for IVDs was expressed by the Microbiology Device Classification Panel which agreed to down classify microbiological culture media from Class II (performance standards) to Class I (general controls) furthering the importance of vigorous implementation of the GMP regulation.