Non-Device MDDS Clarifications (FDA)

KhPat

Starting to get Involved
#1
Hello,

I am hoping someone could provide some clarifications regarding FDA's non-device MDDS classification. We are a manufacturer based in Canada and we would like to have a software approved which uses three (3) FDA approved sensors (one that we manufacture and two of other manufacturer). All sensors are to be connected to one single user interface which will take the data from these sensors and simply display it on the UI (no calculations are happening).

Would this be considered a software functions under FDA's regulatory oversight or a non-device MDDS, if anyone has seen a similar situation before. How are they marketed in the USA? If any specific guidance documents which I can refer to please kindly share it would be appreciated.

Thank you!
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#3
It depends what you intend that information to be used for.
If you transfer that data, for example just for record keeping, then it's not regulated, but if you display the data real-time or near-real-time for monitoring, then probably regulated.
Keep in mind that it's not only the functionality but also what you say to the user of the data they can do with the data.
 

KhPat

Starting to get Involved
#5
I would say it depends on the "3 FDA approved sensors".
Here are some readings that might help.


So the three sensors can be connected to the display monitor (which has the software) to display ECG, oxygen saturation and tissue oxygen saturation. Basically all three sensors are already approved but there will be a software developed to display this information on a single user interface.
 

mihzago

Trusted Information Resource
#6
what is the purpose of displaying this information and who is it displayed to?
are there other cleared software devices that perform same or similar function?
 

KhPat

Starting to get Involved
#7
what is the purpose of displaying this information and who is it displayed to?
are there other cleared software devices that perform same or similar function?
This software will allow healthcare providers to continuously display these parameters in all settings in which critical care is provided. Each of the sensors have been approved by FDA as their own systems which includes sensors + software. However, I am not 100% sure if there is any other cleared software device that performs same or similar functions.
 

mihzago

Trusted Information Resource
#8
I would say this squarely falls into the regulated area.
I was asking if you know of any similar or competitor devices with clearances/approvals because that's one way to quickly determine if your may be regulated.
I think you'll find a lot of similar devices in the cardiovascular devices panel, Cardiovascular Diagnostic Devices and Cardiovascular Monitoring Devices.
 
Thread starter Similar threads Forum Replies Date
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
A QMS inside a Non medical device firm ISO 13485:2016 - Medical Device Quality Management Systems 4
JoCam Non CE marked device for customer review Other Medical Device Regulations World-Wide 0
B Software as a NON-medical device Medical Information Technology, Medical Software and Health Informatics 23
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
K Relying on mitigations implemented in non-medical device IEC 62304 - Medical Device Software Life Cycle Processes 5
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 8
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Leakage current measurement with non-frequency-weighted device IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
A Medical Device Class 2A, non sterile bodyworn packaging requirements CE Marking (Conformité Européene) / CB Scheme 7
N Medical device non sterile packaging requirement CE Marking (Conformité Européene) / CB Scheme 1
JoCam Non-medical device accessory for a medical device EU Medical Device Regulations 27
N Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S Sell a Non-RoHS device, manufactured before RoHs regulations became effective? EU Medical Device Regulations 2
S Australian Registration of Non-CE Marked Medical Device CE Marking (Conformité Européene) / CB Scheme 2
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
I Label of a Medical Device sold in EU - Non translated information EU Medical Device Regulations 7
J 510k file requirements for non-sterile medical device accessories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
J Non-Sterile Class 2 Medical Device Shelf Life Other Medical Device Related Standards 3
T Self Declaration for CE Class I, Non-Invasive Medical Device EU Medical Device Regulations 10
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
J Biocompatibility for Class I Non-Sterile Medical Device EU Medical Device Regulations 2
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Retrospective DHF for an old non-registered device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R How to go about package validation on a class II, non-sterile device US Food and Drug Administration (FDA) 4
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
T 510k Submission - Class II Software communicates with a Non-Classified Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
W Is a new 510(k) needed? Add Non Medical Device into a Medical Device App Other US Medical Device Regulations 13
A Launching a CE Mark Class I (non-measuring and non-sterilzed) Medical Device EU Medical Device Regulations 1
S Clinical or Non-Clinical Data in 510(k) Submission for a type II Medical Device US Food and Drug Administration (FDA) 1
B FDA Requirements for Retaining Non-Conformance Tags (Medical Device Manufacturers) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Contract Manufacturer of a Non-Invasive, Non-Sterile Device and FDA Registration US Food and Drug Administration (FDA) 2
Q Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Other Medical Device and Orthopedic Related Topics 11
W Is a Non-Automatic Weighing Instrument a Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
sagai Is service related software a non medical device? IEC 62304 - Medical Device Software Life Cycle Processes 4
A Need to register with CA for Class I (Non-Sterile and Non-Measuring) Medical Device EU Medical Device Regulations 4
C Safe Handling of Non-Device Refurbished Medical Equipment US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom