Biomedical Engineering Reference
In-Depth Information
This chapter will outline the most relevant regulations and provide references to
obtain additional information.
7.2 Regulatory requirements
The use of biomaterials for skin loss spans a wide range of materials, from products
which are allograft based (cadaver), products of animal origin derived from
bovine, porcine, equine and other species, such as shark cartilage, and synthetic
materials. The most advanced materials are often a combination of products
incorporating drugs as biologics in a delivery device or products that are cell
seeded with human tissue (patient or donor tissue) as well as growth factors.
There have been significant advancements using biomaterials and a combina-
tion of biomaterials for the treatment of skin loss resulting from burns, trauma, or
other disease entities and injuries which have had dramatic results in patient
outcomes and quality of life. These advanced biomaterials and combinations of
these materials also present challenging regulatory approval pathways. There are
requirements and regulations governing advanced biomaterials, combination prod-
ucts and products of human and animal origin. As technology advances, the
regulatory processes are changing as well to ensure the safety and effectiveness of
these high technology products.
There are several regulatory pathways in the United States (USA) through the
Food and Drug Administration (FDA) for approval. The initial step in the approval
process is to determine the classification of the product. There is a similar process
and classification system for product approval in the European Union as part of the
CE Mark certification process under the Medical Device Directive.
1
Classification
of a product determines the pathway for product approval in almost every country
with medical device regulations. The classification determines the relative risk of
the product and this determines the amount of data and testing needed to support
the safe use of the product. The classification of the product also determines the
regulatory pathway.
It must first be determined whether the product will be classified as a pharma-
ceutical or a drug, device, or biologic, or a combination of these categories.
Regulations regarding human tissue will also be discussed, which will be subject
to the regulations for human tissue and cellular based products.
This chapter will concentrate on the regulatory approval and clinical trial
process for medical devices and combination products in the USA by the FDA and
in the European Union under the Medical Device Directive.
7.2.1
Definition of a medical device
The definition of a medical device is an
'instrument, apparatus, implement, machine, implant,
in vitro
reagent, or
