Biomedical Engineering Reference
In-Depth Information
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labeling for the device and predicate device
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device description/substantial equivalence evaluation to the predicate device
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software information (if applicable)
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performance testing - examples: thermal, mechanical and electrical safety,
electromagnetic compatibility/electromagnetic interference (if applicable)
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biocompatibility testing
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animal and clinical data (if applicable)
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sterilization information (if applicable)
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510(k) summary
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indications for use statement
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truthful and accurate certification.
The Food and Drug Administration premarket approval process (PMA)
The Premarket Approval Process (PMA) is required for most Class III devices.
Most of the high technology and advanced biomaterials for treating skin loss have
been subject to the PMA process. These include many of the products discussed in
this topic such as INTEGRA Dermal Regeneration Template (Integra LifeSciences,
Plainsboro, NJ), DermaGraft (Advanced BioHealing, La Jolla, CA) and Apligraf
(Organogenesis, Canton, MA). The FDA considers the following factors in
determining the safety and effectiveness of a product: persons for whose use the
device is intended; adequate directions for use; probable benefit to health from use
weighted against any probable injury or illness from use of the device; reliability
of the device; valid scientific evidence and clinically significant results for a
significant portion of a target population. The clinical data must support the
intended use and provide reasonable assurance of safety and effectiveness.
The conduct of clinical trials under an FDA approved Investigation Device
Exemption (IDE) will be reviewed in more detail under the clinical trial require-
ments.
The PMA is the approval process for most Class III medical devices and is
governed by the Center for Devices and Radiological Health or Biological Product
where both are required to achieve the intended use, indication or effect [21 CFR
3.2(e)].
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7.3
Medical device approval in the European Union
In the European Union, medical devices are regulated under the Medical Device
Directive (MDD), Council Directive 93/42/EEC of 14 June 1993.
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Article 3 of the
MDD states 'The device must meet the essential requirements set out in Annex I
[of the MDD] which apply to them…'.
7.3.1
CE mark certification
Devices considered to meet the essential requirements must bear the CE mark of
