Federal
Food Drug & Cosmetic (FD&C) Act section 201(h) have
device definition.
A device is:
· "an
instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part,
or accessory which is:
1. recognized
in the official National Formulary, or the United States Pharmacopoeia, or any
supplement to them,
2. intended
for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man, or
3. intended
to affect the structure or any function of the body of man, and
which does not achieve its primary intended purposes through chemical action
within or on the body of man and
which
does not achieve its primary intended purposes through chemical action
within or on the body of man and which is not dependent upon being
metabolized for the achievement of its primary intended purposes.
The term
"device" does not include software functions excluded pursuant to
section 520(o).
The
following software functions are excluded from device definition,
· Software Function Intended for Administrative Support of a Health Care Facility
· Software Function Intended for Maintaining or Encouraging a Healthy Lifestyle
· Software Function Intended to Serve as Electronic Patient Records
Click here to
know more about software function which are excluded from device defintion.
Device
definition includes In vitro diagnostic product (IVD).
Definition:
In vitro diagnostic products are those reagents, instruments, and systems
intended for use in diagnosis of disease or other conditions, including a
determination of the state of health, in order to cure, mitigate, treat, or
prevent disease or its sequelae. Such products are intended for use in the
collection, preparation, and examination of specimens taken from the human
body. [21 CFR 809.3]
Regulatory
authority: 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.
CDRH
regulates radiation-emitting electronic products (medical and non-medical) such
as lasers, x-ray systems, ultrasound equipment, microwave ovens and color
televisions.
CDRH
regulates the devices including (medical devices and IVDs).
IVDs are
considered as biological products subject to section 351 of
the Public Health Service Act. They are generally also subject to
categorization under the Clinical Laboratory Improvement Amendments (CLIA
'88) of 1988.
Other
Regulatory authority:
Center for Drug Evaluation and Research (CDER): Human drugs
Center for Biologics Evaluation and Research (CBER): Biological products which
include blood and blood products, and blood banking equipment
Center for Veterinary Medicine (CVM):Products used with animals
References:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance
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