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Medical Devices Approval
Process
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Objectives
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Define a medical device
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Be familiar with the classification system for medical devices
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Understand the difference between medical device approval
and medication approval
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Define 510(k) Premarket Notification
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Explain the role of the Food and Drug Administration (FDA)
in the medical device approval and review process in the
United States
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Medical Devices
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The Food, Drug and Cosmetic Act of 1938 defined devices as
“Instruments, apparatus, and contrivances, including their
components, parts and accessories, intended for use in the
diagnosis, cure mitigation, treatment or prevention of disease
in man or other animals; or to affect the structure or any
function of the body of man or other animals“
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FDA Role
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FDA's Center for Devices and Radiological Health (CDRH) is
responsible for regulating firms who manufacture,
repackage, relabel, and/or import medical devices sold in
the United States. In addition, CDRH regulates radiationemitting electronic products (medical and non-medical) such
as lasers, x-ray systems, ultrasound equipment, microwave
ovens and color televisions.
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Classification of Medical Devices
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Medical devices are classified into Class I, II, and III
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Regulatory control increases from Class I to Class III. The device
classification regulation defines the regulatory requirements for a
general device type.
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Most Class I devices are exempt from Premarket Notification
510(k); most Class II devices require Premarket Notification 510(k);
and most Class III devices require Premarket Approval.
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Class I Devices: General Controls
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Class I: Devices for which general controls are sufficient to
provide reasonable assurance of safety and effectiveness
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General Controls are:
– Adulteration and misbranding provisions
– Registration and listing
– Premarket notification (510(k))* (for a limited number of Class I
devices)
– Records and reports
– Good Manufacturing Practices (unless exempt)

Examples: scalpels, tongue depressors
* 510 (k) submission is to demonstrate substantial
equivalence to a device that is already legally marketed.
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Class II Devices: General Controls and
Special Controls
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Class II: Devices for which general controls alone are
insufficient to establish safety and effectiveness. Must meet
general controls as well as special controls
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Special Controls are:
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Performance standards
– Postmarket surveillance
– Patient registries, guidelines recommendations, and
“other appropriate actions”
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Examples: Laser for general surgery, diagnostic ultrasound,
many intravascular devices
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Class III Devices: General Controls and
Premarket Approval
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Class III: Devices for which general and special controls
alone are not sufficient to establish safety and efficacy and
devices that are:
(i) used in supporting or sustaining human life or
(ii) are for a use which is of substantial importance in preventing
impairment of human health or
(iii) present a potential unreasonable risk of illness or injury
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Examples: artificial hearts, laser for ophthalmic surgery,
many spinal implants
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Premarket Approval
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Class III devices are subject to premarket approval (PMA)
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Could be Class III because of high risk or because of lack of
predicate device
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Once a device is in Class III for a certain indication, all
devices of that kind must have a PMA
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Investigational Device Exemption (IDE)
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Investigational Device
– Is still in the developmental stage
– Is the object of a clinical investigation to determine safety &
effectiveness
– Is not considered to be in commercial distribution
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Investigational Use
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Clinical evaluation of a legally marketed device for a new
intended use
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Investigational Device Exemption (IDE)
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Sponsor submits IDE to FDA
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FDA approves or disapproves within 30 days
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Sponsor obtains IRB approval
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After both FDA and IRB approve, sponsor can begin
investigation
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For non-significant risk IDEs sponsor presents protocol to IRB
and a statement why investigation does not pose significant
risk
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If IRB approves, investigation can begin
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Premarket Notification (510(k))
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510(k) is a premarket submission to the FDA that
demonstrates that the device is substantially equivalent to a
legally marketed device
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What is substantially equivalent?
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The device is:
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Has the same use
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Has the same technological characteristics
Does not require same clinical research as required of
medications
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Clinical Data Requirements
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90% or more of 510(k) notices do not require clinical data
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Clearance based on bench testing and/or animal testing,
identified through appropriate risk analysis
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All PMAs generally require clinical data
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Foreign data may be used but is rarely the sole basis for a
PMA
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Medical Device User Fees
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User Fees for Device submissions
• 510(k): $3,833 standard fee
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PMA, PDP, PMR (reprocessed), BLAs for devices:
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$259,600 standard fee
• Reduced fees for small businesses
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Resources
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http://www.fda.gov/medicaldevices/deviceregulationandgui
dance/default.htm