Biomedical Engineering Reference
In-Depth Information
7
The regulatory approval process for
biomaterials for treating skin loss
J. E. O'GRADY
Integra LifeSciences Corporation, USA
Abstract:
The regulatory approval and registration process for biomaterials
for treating skin loss can be complicated and is evolving as technology
advances. This chapter reviews the approval process in the United States of
America with the FDA and the approval process in the European Union. The
510K premarket notification, premarket approval (PMA), design dossier
under the Medical Device Directive process, regulations and procedures are
delineated. The clinical trial process, regulations and protocol considerations
for biomaterials for treating skin loss are discussed. Special considerations
and regulations for human and cellular based biomaterials and combination
products are summarized. The user fees for various submissions are also
discussed. Sources for further review of regulations, guidance, documents
and information on the regulatory approval and registration process are
provided. Future trends such as the harmonized submission of a summary
technical documentation submission that is accepted by all regulatory
agencies and other globally harmonized submissions are reviewed.
Key words:
regulatory approval, Food and Drug Administration (FDA),
Medical Device Directive (MDD), biomaterials for skin loss, combination
products, clinical trials, medical devices.
7.1
Introduction
The regulatory approval process for biomaterials for the treatment of skin loss
varies greatly depending on the type and source of the biomaterial and more
importantly, the indication for use for the product. As technology progresses and
more advanced biomaterials evolve, as well as combinations of biomaterials in one
product, the regulatory approval process becomes more complicated and detailed.
Incorporated in the regulatory approval process is the compilation of clinical data
to produce valid scientific evidence of safety and efficacy, and to support the
indication for use. At the same time, more countries are recognizing that there need
to be new standards to regulate these advanced medical products for the treatment
of skin loss.
This chapter discusses the regulatory process for biomaterials for skin loss in the
United States of America and the European Union. There are extensive regulations,
standards and guidance documents regarding the regulatory approval process.
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