ISO 13485:2003
FDA
cGMP
ISO 9001:2008
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.
ISO 13485:2003 ISO 13485:2003