SBS - The Best Value in QMS software

Validating Software before getting approved as Class 2 device

#1
Hello everyone,
I'm new here and hoping you can help me to find the answer.
If the phone software can record the body sounds (like lung or heart sounds) and use them to detect diseases or symptoms, how can it be possible to offer this software to the users before it passes FDA approval? We need it to get people's feedback and do preliminary validation, we cannot afford to do a clinical validation at this stage yet. I searched that there are many phone software that detect disease from face pictures and they just use a disclaimer that they are not medical devices and not offering diagnosis. But since we collect the bio sounds from users, I have a concern that this can fall under different rules. I wonder if there is a solution to this.
Thank you very much for your answers!
 
Elsmar Forum Sponsor

monoj mon

Quite Involved in Discussions
#2
I don't have any experience with SaMD, and will try to give my two cents based on my limited knowledge on SaMD.

I would like to know how you have classified your device as Class 2? Do you have any predicate device based on which you have decided that your device falls in that classification? If you have found any predicate then simply look into their 510(k) notification to check what type of testing they conducted.

If you don't have any predicate then I am afraid it would be considered as 'De Novo' by the FDA and may eventually require clinical evidence in your submission. Check the De Novo classification for the Apple ECG App. You better confirm it with FDA itself by requesting a Pre-Sub.

But if you are only concerned to conduct the 'usability' testing, then you could be able to provide the software to the users to record their feedback on 'usability' of the user interfaces.

However, looking at your question again and again, I assume that you are more concerned about the performance testing for the 'Safety and Effectiveness' of the device. For that, if you don't have any predicate to show equivalence and if you don't have a long history of safe usage to prove safety and effectiveness of the deice then you might end up with the De Novo classification and very unlikely that you would get clearance without clinical evidence.
 

Watchcat

Trusted Information Resource
#3
I do have some experience with SaMDs. IMO, you need a regulatory consultant. Now. I am of course biased, since I am one, but really, don't try to DIY this one.

You can offer it to users before it passes FDA approval, but then you'd probably be subject to all kinds of unpleasant FDA enforcement actions, so this course of action is not recommended.

PS Last I heard, FDA was just saying no to pre-subs. Maybe something to do with not having enough resources due to some pandemic or another. Also speculation that they had originally expected to be able to start charging user fees for pre-subs in October, but then MDUFA negotiations got pushed back, and they don't want to do them any more without getting paid.
 

Watchcat

Trusted Information Resource
#4
An update on pre-subs....

Graematter just reported 90- to 120-day delays. So apparently still happening...for some.
 

mihzago

Trusted Information Resource
#5
If you are looking to do some feasibility testing, and ask a few people to use it without providing the results to them, and without making any medical claims, and being clear that you’re just collecting data as proof of concept, and you don’t plan on using these results in the submission, then maybe there is a way. A more defensible way would be to obtain an IRB approval.

better yet, as Julie suggested, find a consultant you could ask for a more comprehensive advice.
 

yodon

Staff member
Super Moderator
#6
since we collect the bio sounds from users, I have a concern that this can fall under different rules.
Your concerns are well-founded. Patient privacy is a big deal these days and collecting protected health information, as you are suggesting, could get you into very hot water. I agree with @mihzago that you probably want to get more comprehensive advice from a regulatory expert. Expert advice here would well be worth the cost.
 
Thread starter Similar threads Forum Replies Date
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
M FDA's expectation for validating OTS software updates Other US Medical Device Regulations 8
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
M Validating 3rd Party Software which Tracks Archived Samples Qualification and Validation (including 21 CFR Part 11) 2
G Software Validating Adobe Professional according to Part 11? Quality Assurance and Compliance Software Tools and Solutions 10
D Validating software in materials testing - Integrated system of individual components General Measurement Device and Calibration Topics 3
Ed Panek Validating Excel (XLS) formulas 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
H Validating Nondestructive leak testing machine Qualification and Validation (including 21 CFR Part 11) 3
S Validating a Bonding Process Qualification and Validation (including 21 CFR Part 11) 3
J Validating a stopped test due to never finding any defects Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Validating multiple injection molding machines efficiently ISO 13485:2016 - Medical Device Quality Management Systems 5
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Meeting the Requirement of Clause 7.5.2 on Validating Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Validating a Product through Tool Control and Tool Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
G Validating a Sandblasting Process - Any pointers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
G Testing and Validating a New Vertical Milling Machine AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Q Validating Tape Measures used to Measure Product Conformity to Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
T Validating Supplier Statement - Rusty shield that supplier denied responsibility Manufacturing and Related Processes 7
Q Validating ESD (Electrostatic Discharge) Flooring ISO 13485:2016 - Medical Device Quality Management Systems 2
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
Q Validating the AOI process (Automated Optical Inspection) Reliability Analysis - Predictions, Testing and Standards 9
K Validating a gage/fixture in-house under TS 16949 - Need information General Measurement Device and Calibration Topics 2
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
C Validating a Gage R&R spreadsheet - Defining Formulas in spreadsheet cells Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Validating Multimeters (how to) General Measurement Device and Calibration Topics 8
J Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 1
BeaBea QMS/ Training Management Software Service Industry Specific Topics 1
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Y RT-qPCR Software result EU Medical Device Regulations 0
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
F WANTED Senior Software engineer Career and Occupation Discussions 2
P Blood establishment computer software EU classification EU Medical Device Regulations 0
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
D Integrated Management System Software Quality Manager and Management Related Issues 2
B Sampling strategies/techniques for software QA Software Quality Assurance 2
K MDCG-2020-3 (about the software of UI) EU Medical Device Regulations 3
D PFMEA Software search IATF 16949 - Automotive Quality Systems Standard 6
C MDR software classification EU Medical Device Regulations 12
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0

Similar threads

Top Bottom