MUHIMBILI UNIVERSITY OF HEALTH AND

ALLIED SCIENCES

CODE: BME 410

COURSE: Quality Assurance In Medical
Devices
CHAPTER 1: Introduction to Medical
Devices
FACILITATOR: OMAR R KOMBO

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Definition
• A medical device is defined as any instrument, apparatus,
machine, implant, in vitro reagent or calibrator, software,
material or other related article, intended by the
manufacturer to be used, alone or in combination, for
human beings for diagnosis, treatment, or prevention of
disease or other medical conditions.
• And which does not achieve its principal intended action
by pharmacological, immunological or metabolic means,
in or on the human body, but which may be assisted in its
function by such means.

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Definition
• According to FDA, the specific purpose of medical
devices should be:
☛ Diagnosis, prevention, monitoring, treatment, alleviation of
disease or disability,
☛ Diagnosis, monitoring, treatment, alleviation of or compensation
for an injury,
☛ Investigation, replacement, modification, or support of the
anatomy or of a physiological process,
☛ Supporting or sustaining life,
☛ Control of conception,
☛ Disinfection of medical devices.
☛ Providing information my means of in vitro examination.
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Definition
• Additional products in the scope – list of groups or
products which are recognized as medical devices but
not intended as medical purpose include:
☛ Aesthetic contact lenses.
☛ Aesthetic implant excluded tattooing products or piercing.
☛ Substance like Botox (Hyaluronic Acid) excluded tattooing.
☛ Equipment for reducing adipose tissue.
☛ Pulse light equipment for skin resurfacing, tattoo or hair removal
(sunbathing can be included).
☛ Equipment for brain simulation.

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Examples of medical devices
• Wound dressing
☛ Injury – treatment and protection
• Glucometer
☛ Disease – diagnosis and monitoring
• Contact lens
☛ Anatomy – modify and support
• Infusion set
• Physiological process – support and sustain
• X-ray/CT scan
• Disease and anatomy – diagnosis, monitoring and investigation

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Classification of medical devices
• Before placing a product on the market as a medical
device, it must first qualify as a medical device.
• Once a product meets the definition of a medical device,
it must then be correctly classified.
• The FDA regulates all medical devices into three risk
categories:
☛ Class I – lowest risk
☛ Class II – moderate risk
☛ Class III – highest risk

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Classification of medical devices
• The classification rules are based on different criteria such
as the duration of contact with the patient, the degree of
invasiveness, intended purpose of the device, and the
part of the body affected by the use of the device.
• Before you begin creating a medical device, you need to
know what class it falls under so you can follow the correct
procedures and regulations set by the FDA.
• With this knowledge, medical device manufacturers in the
premarket stages can better prepare and allocate the
resources needed for regulatory approval.

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Class I medical devices
• Class I medical devices are those under current law for
which general controls are sufficient to provide
reasonable assurance of the safety and effectiveness of
the device.
• Many Class I devices are exempt from the premarket
notification and/or the Quality System (QS) regulation
requirements, though they still have to comply with the
other general controls.
• A device is exempt if FDA determines that it presents a low
risk of illness or injury to patients.
• Examples of class I medical devices are stethoscope,
spectacles, bandages, gloves etc.
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Class II medical devices
• Class II medical devices are those under current law which
cannot be classified as class I because the general
controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness of the
device.
• Class II includes devices that pose a moderate risk to
patients, and may include new devices for which
information or special controls are available to reduce or
mitigate risk.
• Special controls are usually device specific and may
include special labelling requirements, mandatory
performance standards, and post-market surveillance.

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Class III medical devices
• Class II medical devices are devices that the general
and/or special controls are not sufficient to assure their
safe and effective use.
• Class III includes devices which are life-supporting or life-
sustaining, and devices which present a high or potentially
unreasonable risk of illness or injury to a patient.
• New devices that are not Class I or II are automatically
designated as Class III unless the manufacturer files a
request or petition for reclassification.
• Examples of class III medical devices are pacemakers, hip-
joints, brain stimulator.

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General control
• General controls are the baseline requirements that apply
to all medical devices, regardless of their level of risk.
• These controls include:
☛ Establishment registration and device listing
☛ Medical device reporting
☛ Quality system regulation
☛ Labelling requirements
☛ Good manufacturing practices

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Special control
• Special controls are specific requirements that apply to
certain types of medical devices that present higher levels
of risk to patients.
• These controls may include:
☛ Performance standards
☛ Post-market surveillance
☛ Patient registries
☛ Special labeling requirements
☛ Clinical data requirements
☛ Premarket approval

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General Control vs Special Control
General Control Special Control
• Registration • Special labelling
• Listing of medical devices requirement
• Adultaration • Performance standards
• Misbranding • Pre-market surveillance

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Criteria for classification
• As discussed earlier, the classification rules are based on
different criteria such as the duration of contact with the
patient, the degree of invasiveness and the part of the
body affected by the use of the device.
• Intended purpose of medical devices – The use for which
the device is intended according to the data supplied by
the manufacturer on the labelling, in the instructions
and/or in promotional materials.

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Duration of contact
☛ Transient – intended for continuous use for less than 60 minutes
☛ Short term – intended for continuous use for not more than 30
days
☛ Long term – intended for continuous use for more than 30 days.
• In certain instances the duration of effect for a product needs
to be considered as the duration of use.
• For instance, application of a topical cream to the skin may
only take seconds to apply but the cream may remain in situ
for many hours.
• The duration of use should therefore not be considered as the
time taken to apply the product but rather the duration for
which the product achieves its intended purpose.

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Invasiveness
• Invasive device – a device which, in whole or in part,
penetrates inside the body, either through a body orifice
or through the surface of the body
☛ Body orifice – any natural opening in the body, as well as the
external surface of the eyeball, or any permanent artificial
opening, such as a stoma.
• Surgically invasive device – an invasive device which
penetrates inside the body through the surface of the
body, with the aid of or in the context of a surgical
operation.
☛ They produce penetration other than through an established
body orifice.

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Invasiveness
• Implantable device – any device which is intended to be
totally introduced into the human body or to replace an
epithelial surface or the surface of the eye by surgical
intervention which is intended to remain in place after the
procedure.
☛ Any device intended to be partially introduced into the human
body through surgical intervention and intended to remain in
place after the procedure for at least 30 days is also considered
an implantable device.

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Invasiveness
• Reusable surgical instrument – Instrument intended for
surgical use by cutting, drilling, sawing, scratching,
scraping, clamping, retracting, clipping or similar
procedures, without connection to any active medical
device and which can be reused after appropriate
procedures have been carried out.

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Active medical devices
• A medical device operation of which depends on a
source of electrical energy or any source of power other
than that directly generated by the human body or
gravity and which acts by converting this energy.
☛ Medical devices intended to transmit energy, substances or
other elements between an active medical device and the
patient, without any significant change, are not considered to
be active medical devices.
☛ Stand alone software is considered to be an active medical
device.

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Active medical devices
Active therapeutic device – any active device used,
whether alone or in combination with other devices, to
support, modify, replace or restore biological functions or
structures with a view to treatment or alleviation of an illness,
injury or disability.
Active device intended for diagnosis and monitoring – any
active device used, whether alone or in combination with
other devices, to supply information for detecting,
diagnosing, monitoring or treating physiological conditions,
states of health, illnesses or congenital deformities.

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Medical devices review process
• FDA requires all medical product manufacturers to register
their facilities, list their devices with the agency, and follow
general controls requirements.
• FDA classifies devices according to the risk they pose to
consumers.
• Many medical devices, such as plastic bandages and ice
bags, present only minimal risk and can be legally
marketed upon registration alone.

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Medical devices review process
• The low-risk medical devices are deemed exempt from
premarket review and manufacturers need not submit an
application to FDA prior to marketing.
• In contrast, most moderate- and high-risk devices must
obtain the agency’s permission prior to marketing.
• FDA grants this permission when a manufacturer meets
regulatory premarket requirements and agrees to any
necessary post-market requirements which vary
according to the risk that a device presents.

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Regulatory pathways
• This include the following:
☛ Pre-market notification 510(k)
☛ Pre-market approval (PMA)
☛ De novo
☛ Humanitarian device exemption (HDE)

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Pre-market notification 510(k)
• It is the most common route taken when launching a
medical device.
• It involves submitting a 510(k) notification demonstrating
that the device is substantially equivalent to a device
already on the market (predicate device).
• A predicate device is a legally marketed device that does
not require a PMA.
• Substantial equivalence is determined by comparing the
performance characteristics of a new device with those of
a predicate device.

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Pre-market notification 510(k)
• To be considered substantially equivalent, the new device
must have the same intended use and technological
characteristics as the predicate; clinical data
demonstrating safety and effectiveness are usually not
required.
• 510(k) review takes up to 90 days to verify a new device
and consider whether it is of the same classification as the
predicate device.
• If not substantially equivalent, your device is classified as
class III.

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Pre-market Approval (PMA)
• Class III devices and any other device that cannot
provide substantial equivalence to a class I or II device
through the 510(k) process must use PMA pathway.
• The PMA process is the most involved as scientific
evidence, typically in the form of a clinical trial, is needed
to prove the safety and effectiveness of your device.
• It takes 180 to 320 days to complete and it should show
that
☛ The potential benefits of the device completely outweigh the
possible risks it could have.
☛ The device will benefit the target market.
☛ The device is independent.
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De novo
• Devices that are low to moderate risk for which there is no
predicate device may be candidates for the de novo
pathway.
• This pathway allows FDA to classify new types of devices
into class I and II, if FDA determines that it can identify the
appropriate special controls to ensure a reasonable
assurance of safety and effectiveness.
• From the perspective of a submitter, this generally involves
more work than a 510(k), but much less than a PMA.

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Humanitarian device exemption (HDE)
• This pathway is for class III devices that are intended to
treat or diagnose conditions or diseases that affect small
populations (fewer than 4000 individuals).
• The pathway involves a two step process.
☛ The FDA must grant Humanitarian Use Device (HUD) exemption.
☛ The company must then submit an HDE application to
appropriate review centre.
• Similar to PMA, but does not need to demonstrate
effectiveness.
• It must show that the probable benefit exceeds probable
risk.

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Summary
Class I Class II Class III

Risk Level Low risk Moderate risk High risk

Regulatory Control General control General Control + General Control +

Special Control Special Control +
Premarket
Approval
Regulatory Registration only Requires 510(k) Requires PMA or
Pathway unless 510(k) unless specifically HDE
specifically exempted
required
Examples • Sunglasses • Dental implants • Heart valves
• Stethoscope • X-ray machines • Pacemaker
• Toothbrush • Wheel chair • Defibrillator

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Medical devices essential requirements
• Medical device essential requirements refer to the
fundamental safety and performance criteria that
medical devices must meet to be sold legally in various
countries.
• These requirements ensure that medical devices are safe,
effective, and reliable for patients, healthcare providers,
and other users.
• The essential requirements cover various aspects of
medical device design, manufacture, and performance.

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Medical devices essential requirements
• General safety and performance
☛ The design should ensure safety and performance in
accordance with their intended purpose.
• Biocompatibility
☛ Must not cause harmful interactions with the human body, and
their materials and components must be biocompatible.
• Sterilization and cleaning
☛ Allow effective sterilization and cleaning, and their packaging
must be suitable for maintaining sterility.
• Clinical evaluation
☛ Must be clinically evaluated to demonstrate their safety and
performance.
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Medical devices essential requirements
• Risk management
☛ Manufacturers must identify and mitigate potential risks
associated with their devices.
• Labelling and instructions for use
☛ Devices must be labelled and accompanied by instructions for
use that are clear and easy to understand.
• Post-market surveillance
☛ Manufacturers must have systems in place to monitor the safety
and performance of their devices once they are on the market.

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