See Full Document Text
Appendix-A
File No. 29/Misc./03/2020-DC (198)
Drugs Controller General (India)
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, Kotla Road, New Delhi
Notice
Classification of Medical Devices Pertaining to Software
Risk
S.No Device Name Intended Use
Class
Continuous
Glucose
Continuous glucose monitor retrospective data analysis software is intended to
Monitor
1 analyze and correlate retrospective data from a continuous glucose monitoring A
Retrospective
device.
Data Analysis
Software
Continuous
Glucose The purpose of the continuous glucose monitor secondary display is to notify
2 Monitor another person, the follower, of the patient's continuous glucose monitoring B
Secondary system sensor glucose information in real time.
Display
Insulin Pump
The purpose of the insulin pump secondary display is to notify another person
3 Secondary B
of the patient's insulin pump usage information in real time.
Display
Insulin Pump
An insulin pump therapy adjustment calculator for healthcare professionals is
Therapy
intended to recommend insulin pump therapy parameter adjustments (e.g.,
Adjustment
4 basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on C
Calculator For
data from external devices, including continuous glucose monitors. The device
Healthcare
is software with a graphical user interface.
Professionals
Coronary
A coronary vascular physiologic simulation software device is intended to aid in
Vascular
the identification of functionally significant cardiovascular disease by performing
5 Physiologic C
offline analysis of pre-existing imaging data to simulate blood flow in the
Simulation
coronary vasculature.
Software
Multivariate Automated calculation of a summary index (or indices) based on several
6 Vital Signs individual measured vital sign inputs. Collects measured parameter inputs and B
Index automates the calculation of a summary index based on those parameters
Electrocardiogr Device intended for home use which creates, analyzes, and displays
7 aph Software electrocardiograph data, and can provide information for identifying cardiac B
for home use. arrhythmias.
Photoplethysm
ograph Photoplethysmograph analysis software device for home analyzes of
8 Analysis photoplethysmograph data and provides information for identifying irregular B
Software for heart rhythms. This device is not intended to provide a clinical diagnosis.
home use.
Angiographic
Coronary
An angiographic coronary vascular physiologic simulation software device is
Vascular
9 intended to aid in the identification of functionally significant cardiovascular C
Physiologic
disease.
Simulation
Software
1 of 7Software For
Visualization Of
Vascular Visualization and measurement of blood vessels and intravascular devices for
10 C
Anatomy And preoperational planning.
Intravascular
Devices
Orthodontic The device is software that is to be used for the diagnosis and treatment
11 C
Software planning of orthodontic patients and conditions.
Dental
The software device is intended to aid in the restoration of chewing function by
Abutment
allowing a dental laboratory or dental clinician to design the patient-specific
Design
12 component of a dental abutment (i.e. abutment collar and abutment post) and C
Software For
CAM or create that component at a dental office or dental laboratory following
Dental
the directions of the dental implant system.
Laboratory
Diagnostic
Software, K-
Nearest The device is intended to suggest a systemic autoimmune disease association
13 Neighbor as an aid for differential diagnosis to be evaluated in conjunction with clinical B
Algorithm, findings and other laboratory tests.
Autoimmune
Disease
Neuropsychiatri
c Interpretative
Electroencepha Intended as an aid to provide an interpretation of the patient's neuropsychiatric
14 C
lograph condition.
Assessment
Aid
Normalizing
Quantitative
Post-hoc statistical analysis of electroencephalograph signals with comparison
15 Electroencepha C
to a normative database for interpretation by a qualified clinical user.
lograph
Software
Index-
Generating Analyze electrical activity of the brain by transformation of
16 Electroencepha electroencephalograph signals into a dimensionless index number for use and C
lograph interpretation by a qualified clinical user.
Software
Source
Localization
Software For
Correlation of electrical activity of the brain using various neuroimaging
17 Electroencepha C
modalities for source-localization
lograph Or
Magnetoencep
halograph
Automatic
Event
Automatically mark electroencephalograph and polysomongraph signals in
Detection
order to aid in identification of such events and annotation of prolonged PSG
Software For
18 traces; Automatically calculate simple measures obtained from recorded signals C
Polysomnograp
(e.G. Magnitude, time, frequency and simple statistical measures of marked
h With
events); All output subject to verification by qualified clinical user
Electroencepha
lograph
2 of 7Automatic
Event
Automatically mark or identify electroencephalograph waveforms for spikes,
Detection
electrographic seizures, seizure-like events in order to aid in identification of
19 Software For C
such events and help review and annotation of prolonged EEG traces; All
Full-Montage
output subject to verification by qualified clinical user
Electroencepha
lograph
Computerized
Cognitive
20 Assessment For use as an assessment aid in the management of concussion. C
Aid For
Concussion
Ataxiagraph Device used to determine the extent of ataxia (failure of muscular coordination)
With by measuring the amount of swaying of the body when the patient is standing
21 A
Interpretive erect and with eyes closed and provides interpretation or clinical implication of
Software the measurement.
Computerized
Behavioral
The device is intended to provide cognitive behavioral therapy to treat
Therapy
22 substance use disorder. The device is a software-based mobile app C
Device For
downloaded onto a smartphone.
Psychiatric
Disorders
Brain Injury
Adjunctive
A traumatic brain injury eye movement assessment aid is a prescription device
Interpretive
23 that uses a patients tracked eye movements to provide an interpretation of the C
Oculomotor
functional condition of the patients brain.
Assessment
Aid
Device, Fertility
Diagnostic,
Designed to monitor and provide fertility information to prevent pregnancy
24 Contraceptive, C
(contraception).
Software
Application
Diabetic
A retinal diagnostic software device is a software device that incorporates an
Retinopathy
25 adaptive algorithm to evaluate ophthalmic images for diagnostic screening to C
Detection
identify retinal diseases or conditions.
Device
Colon
Computed
Tomography To assist radiologists in the review of multi-slice computed tomography (msct)
26 System, exams of the colon and highlight potential polyps that the radiologist should B
Computer review.
Aided
Detection
Lung
Computed
Tomography To assist radiologists in the review of multi-slice computed tomography (msct)
27 System, exams of the chest and highlight potential nodules that the radiologist should B
Computer- review.
Aided
Detection
Chest X-Ray
Computer To assist radiologists in the review of chest radiographic images and highlight
28 B
Aided potential nodules that the radiologist should review.
Detection
3 of 7Computer-
Assisted
Diagnostic
Assist clinical users in characterizing lesions identified on acquired medical
29 Software For C
images
Lesions
Suspicious For
Cancer
Radiological
Computer A radiological computer assisted detection and diagnostic software for
Assisted suspected fracture is an image processing device intended to aid in the
30 B
Detection/Diag detection, localization, and/or characterization of fracture on acquired medical
nosis Software images (e.g. radiography, MR, CT).
For Fracture
X-Ray
Angiographic
X-ray angiographic imaging based coronary vascular simulation software device
Imaging Based
is a device that provides an image analysis tool to assess blood flow in the
Coronary
31 coronary vascular system using X-ray angiographic imaging data. And yields B
Vascular
simulation-based metrics for certain cardiology applications which aid clinical
Simulation
user.
Software
Device
Automated
Radiological
To provide automated radiological image processing and artificial intelligence
32 Image B
based analysis tools.
Processing
Software
Image
Acquisition
And/Or A radiological acquisition and/or optimization guidance system is a device that
33 Optimization is intended to aid in the acquisition and/or optimization of images and/or B
Guided By diagnostic signals.
Artificial
Intelligence
Burn
Resuscitation The burn resuscitation decision support system (BRDSS) is intended for use in
34 Decision prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is C
Support intended for patients who have greater than 20% total body surface area burn.
Software
Software,
Similarity Score This test is intended to measure the degree of similarity between the RNA
Algorithm, expression pattern in a patient?s fresh-frozen tumor and the RNA expression
35 Tissue Of patterns in a database of tumor samples for some common malignant tumor C
Origin For types that were diagnosed according to then current clinical and pathological
Malignant practice.
Tumor Types
Software for A software that performs prescription simulation of peritoneal dialysis based on
peritoneal the results obtained from a peritoneal function test (PFT), a peritoneal
36 C
dialysis equilibration test (PET) and a body composition analyzer. It supports
treatment preparation of a dialysis treatment plan.
Software for A software that calculates and displays the area to be treated with radiation and
37 radiation the internal dose distribution based on the results obtained with CT systems C
planning etc. , and supports the radiotherapy planning.
4 of 7Software for
A software that verifies the validity of the radiotherapy plan by recalculation of
radiotherapy
38 the dose and the MU value calculated with the radiotherapy planning system C
QAQC
software and radiotherapy planning system.
planning
Software for
ophthalmic
A software for intended to aid ophthalmic surgical planning based on
39 surgery C
measurement of the eye prior to the surgery. It simulates surgical results.
treatment
planning
Software for
active A software used to transmit one or more electrical operating characteristics
40 C
implanted noninvasively to the active base unit and change the characteristics.
device control
Information A software that has function of collating the information such as irradiation
collating parameter specified by a radiation planning software, and the condition that a
41 C
software for radiotherapy equipment irradiates, on the occasion of the irradiation of X-ray in
radiotherapy the radiotherapy.
Software for
gene variants A software for gene variants analysis which is designed to perform cancer
42 analysis (for genome profiling based on information of gene variants obtained from body C
cancer genome tissue samples.
profiling)
Supporting
A software, which is designed to process data obtained from an endoscopic
software for
image. The resultant data are provided for diagnostic, etc. It has functions to
differential
43 output numeric values and graphs based on quantitative data such as C
diagnosis with
benign/malignant differentiation of lesion candidates, presenting candidates of
endoscopic
diagnostic outcomes, and stage of disease progression.
imaging
Chairside
Intended for computer-aided design (CAD) or computer-aided manufacturing
44 dental B
(CAM) of dental restorations.
CAD/CAM unit
Software for
using with
mammography- A software, which is designed to processes data obtained from a combined
45 B
combined diagnostic mammography-radiography system.
diagnostic X-
ray system
Software for
public thoracic
A software, which is designed to process data obtained from a thoracic and
and abdominal
abdominal public health screening diagnostic X-ray system. The resultant data
46 health B
are provided for diagnosis, etc. This term may involve the recording media
screening
where the software are stored.
diagnostic X-
ray system
Software for
visual evoked A software, which is designed to process data obtained from a visual evoked
47 B
response response stimulator. The resultant data are provided for diagnosis, etc.
stimulator
5 of 7Software for
auditory A software for medical device, which is designed to process data obtained from
48 evoked an auditory evoked response stimulator. The resultant data are provided for B
response diagnosis, etc.
stimulator
Software for
pulmonary
A software, which is designed to process data obtained from a pulmonary
49 exercise stress B
exercise stress monitoring system.
monitoring
system
Software for
ECG recorder A software, which is designed to process data obtained from an ECG recorder
50 B
with real-time with real-time analysis. The resultant data are provided for diagnosis, etc.
analysis
Software for
film-recorded A software, which is designed to process data obtained from a film-recorded
51 B
digital digital radiography. The resultant data are provided for diagnosis, etc.
radiography
Software for
dye dilution A software, which is designed to process data obtained from a dye dilution
52 B
cardiac output cardiac output unit. The resultant data are provided for diagnosis, etc.
calculator
Software for
urodynamic A software, which is designed to process data obtained from a urodynamic
53 B
measurement measurement system. The resultant data are provided for diagnosis, etc.
system
Software for
vestibular A software, which is designed to process data obtained from a vestibular
54 B
function caloric function caloric stimulator. The resultant data are provided for diagnosis, etc.
stimulator
Surporting
A software that analyzes information useful for bone fracture and for correction
software for
of bone deformities based on information collected from diagnostic X-ray
55 external B
systems, etc. or based on information entered in a therapeutic apparatus, and
fixators
supports preparation of a treatment plan with external fixators.
treatment plan
Diagnostic
A software that supports analysis and assessment of therapeutic effects of
supporting
56 diabetes treatment by processeing information collected from a blood glucose B
software for
meter, etc into the data related to changes or trends in blood glucose levels.
diabetes
Quantitative
A software that performs quantitative calculation of blood flow in relation to a
calculation
57 brightness time change based on information obtained from video images of B
software for
indocyanine green angiography.
IGC test
Analyzing
software for A medical device program that analyzes hemodynamics or cardiac function
58 hemodynamics based on information obtained from diagnostic imaging systems, etc. and uses B
or cardiac the results for diagnosis.
function
6 of 7Supporting
A software for medical device, which is used to support preparation of a
software for
59 treatment plan based on information collected from diagnostic imaging systems, B
root canal
etc. in the root canal treatment.
treatment
A data program designed for use in, or together with, a ventilator allowing it to
Ventilator,
60 function according to the intended purpose. The software can be installed, or C
software
exchanged as an upgrade.
Note 1 - As per clause (iii) of Part I of First Schedule of Medical Devices Rules 2017, Software, which drives or
influences the use of a device, falls automatically in the same class.
Note 2 - Any add-on to the same software will be treated as same risk class.
7 of 7