Biomedical Engineering Reference
In-Depth Information
other similar or related article, including any component, part or acces-
sory which is:
• recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
• intended to affect the structure or any function of other body of man or
other animals, and
which does not achieve its primary intended purposed through chemical
action within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of any of its
primary intended purposes' [21 USC 321(h)].
2
Devices are classified by FDA as either Class I, II or III in the United States. Class
I devices are those for which general controls are sufficient to provide reasonable
assurance of safety and effectiveness. General controls include complying with
regulations concerning adulteration and misbranding provisions, registration and
listing, premarket notification and other general requirements.
Class II devices are those for which general controls alone are insufficient to
establish safety and effectiveness. Class II devices must generally meet general
controls (including premarket notification requirements for most Class II devices)
as well as special controls, if applicable. Special controls include performance
standards, postmarket surveillance of the product, patient registries, FDA guide-
lines, recommendations and other requirements as indicated.
Class III devices are those for which general controls and special controls alone
are not sufficient to ensure safety and effectiveness. Class III devices as defined by
FDA are those devices used in supporting or sustaining human life; for a use which
is of substantial importance in preventing impairment of human health; which
present a potential unreasonable risk of illness or injury; or are not substantially
equivalent to a legally marketed Class I, Class II device or preamendment Class III
device. Class III devices must meet general controls and must be approved by FDA
prior to marketing the product.
3
The classification of a device can be determined by several methods such as
those listed in the Code of Federal Regulations,
4
researching the FDA Health
Product Code Database,
5
researching a competitive device, contacting the FDA or
reviewing the FDA's website. The Food and Drug Administration has an exten-
sive, informative website which covers a wide variety of topics on regulations and
is a valuable tool for research on the regulatory approval process, FDA Guidance
Documents as well as information available on products cleared via the 510(k)
Premarket Notification or Premarket Approval (PMA) process.
6
