Biomedical Engineering Reference
In-Depth Information
humanitarian device is a 'medical device intended to benefit patients in the
treatment or diagnosis of a disease or condition that affects or is manifested in
fewer than 4000 individuals in the United States per year'.
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The HDE requires that first an application for designation as a humanitarian
device be submitted to FDA prior to submitting the HDE application. The Request
for Designation (RFD) as a HDE must include a description of the device and the
intended disease or condition the device is intended to treat. Documentation must
be submitted to support that the device meets the definition and requirements of an
HDE. The humanitarian device must meet the principle requirements that there are
no comparable devices to treat the disease or condition and that there are less than
4000 people per year affected. There are regulations regarding the cost of an HDE.
The amount charged for the product cannot be more than US$250.00. If the cost is
more than US$250.00, a report must be submitted by a certified public accountant
verifying the amount does not exceed the cost of research, development, fabrica-
tion and distribution of the product.
HDE devices require institutional review board (IRB) approval at the medical
facility prior to the product being used on patients. Products that have a HDE are
subject to the same quality system (good manufacturing practices), amendments,
supplements and reports and regulations as are products approved under the FDA
PMA regulations.
7.9 Human tissue and cellular based products
Many of the biomaterials for the treatment of skin loss may be or contain human
tissue or cellular-based components. The regulatory approval process varies
depending on the type of tissue, whether it is subject to tissue regulations, medical
device or biologic regulations. Regulations regarding human tissue-based prod-
ucts vary as well among countries.
In the United States and European Union, there are similar regulations regarding
the donation, procurement and testing of donors, as well as traceability require-
ments, notification of serious adverse events and tissue establishment accreditation
and inspection
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for products that are made from human and cellular-based
tissue.
In Europe, tissue establishments with activities for testing, processing, preserva-
tion, storage or distribution of human tissue need to be accredited by a competent
authority. In the United States, tissue banks receive accreditation from the Ameri-
can Association of Tissue Banks and must comply with FDA human and
cellular-based tissue regulations. Additionally, tissue banks must also have a tissue
bank license from certain states within the USA.
In Europe and the USA, tissue establishments are subject to accreditation and
inspection for compliance with regulations. There are traceability requirements
from the donor to the recipient. There are stringent requirements for all donor
tissue
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including exclusion of deceased donors for:
