Biomedical Engineering Reference
In-Depth Information
pharmaceutical or biologic product subject of a new drug application (NDA) or
biologic subject to obtaining a biologic license, the product will not receive final
approval until the FDA has reviewed a detailed submission on the quality system
and manufacturing process. These applications usually require an inspection of the
manufacturing facility for compliance with the FDA's quality system regulations
(devices) current good manufacturing practices (drugs) or both if the product is a
combination product.
In the European Union there is a centralized process of CE mark certification. It
is a requirement that the manufacturer and manufacturing facility be certified to the
most current standard for quality systems which is ISO 13485:2003.
This chapter concentrates on the approval process in the USA and the European
Union; however it is noteworthy to mention that almost every other major country
requires compliance and certification of the quality system to ISO 13485:2003.
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The quality system section of a PMA includes quality management, quality
organization, device design, buildings, equipment, purchase and handling of
components, production and process controls, packaging and label control, device
evaluation, distributions, installation, complaint handling, sourcing and records.
The requirements of a quality system under FDA, 21 CFR Part 820
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with ISO
13485:2003 are similar but to date have not been harmonized.
7.7
Clinical trials
The FDA approval process for high technology medical devices, combination
products and pharmaceuticals usually requires clinical trial data. In the European
Union clinical data is required for all submissions and there are revisions to the
Medical Device Directives which further define the clinical data required to
support the CE mark certification of medical devices.
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Clinical trials in the USA for advanced biomaterials for the treatment of skin loss
which are Class III medical devices will require valid scientific evidence of safety
and effectiveness from a clinical trial conducted under an approved investigational
device exemption (IDE)
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or NDA. Clinical trials in the USA and European Union
should be conducted under good clinical practice regulations. Good clinical
practices (GCPs)
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are an international ethical and scientific quality standard for
designing, conducting, recording and reporting clinical trials that involve the
participation of human subjects. Compliance with this standard provides assur-
ance that the rights, safety and well-being of subjects in a clinical trial are protected
and consistent with the principles of the Declaration of Helsinki
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and that the
clinical trial data is credible.
7.7.1 Good clinical practices
The Expert Working Group of the International Council on Harmonization of the
Technical Requirements for Registration of Pharmaceuticals for Human Use
