Software as Medical Device (SaMD) definition and its applicability

akp060

Involved In Discussions
#1
Hello Members,
If we have a Software that meets IMDRF Medical Device definition, and we say that we are using a hardware medical device (which has got regulatory approval/clearance) as an accessory to SaMD, does it mean that it now a Medical Device System and not an SaMD? I am clear that this is not the case, but checking if I could be wrong or other regulatory resources I have not considered. I know SaMD cannot be part of a medical device integrated or accessory, but if a Medical Device Software (62304 terminology) is a medical device in its own and used hardware medical device as accessory, do we still see the software as SaMD?
 
Last edited:
Elsmar Forum Sponsor

primavesvera

Involved In Discussions
#4
Take a look at the Key Definitions guidance for major clarity.
Standalone Medical Device Software Harmonization (SaMD)
Thank You. I have already looked there but i did not get clarity on my query about accessory to SaMD. However, may I ask about the instance you have mentioned; if you are calling the hardware that provides inputs to SaMD, as the SaMD's accessory[/QUOTE]

No, we treat them as a two separate devices, two different intended use.
 

akp060

Involved In Discussions
#5
Thank You. I have already looked there but i did not get clarity on my query about accessory to SaMD. However, may I ask about the instance you have mentioned; if you are calling the hardware that provides inputs to SaMD, as the SaMD's accessory
No, we treat them as a two separate devices, two different intended use.[/QUOTE]


Thank You, meanwhile, I checked the Accessory guidance from the FDA, and also based on your post, I now have the answer. Thank you so much!

FDA requires that for calling any device as an accessory it should be labeled for use with the Subject Device, in my case the SaMD.
 
Thread starter Similar threads Forum Replies Date
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
Z Software Library - could it be a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
D Requirements for the dimensions / color of medical device labels - Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 6
D IEC 60601 for a Software only Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
S Two Questions about Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
R Online / Cloud Based Software as Medical Device EU Medical Device Regulations 8
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
S Labelling in Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
JoCam Medical Device Software - Apps which can control medical devices EU Medical Device Regulations 13
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
N Medical Device Software - Switch from Waterfall to Agile methodology Medical Information Technology, Medical Software and Health Informatics 4
V Software medical device labelling EU Medical Device Regulations 5
I Medical Device Software Risk Analysis ISO 14971 - Medical Device Risk Management 4
S If a piece of software receives approval as part of a medical device system Canada Medical Device Regulations 5
C Controlling Software Versions that are part of a medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
S Cloud-Based Stand Alone Software - Software Medical Device (Class II) US Food and Drug Administration (FDA) 2
Q QMS Software for Startup Medical Device Company Other Medical Device and Orthopedic Related Topics 7
B CQC oversight of Medical device software? EU Medical Device Regulations 3
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
B Is IEC TR 80002-1:2009 applicable to stand-alone medical device software? ISO 14971 - Medical Device Risk Management 1
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
T Are internally found Medical Device Software "Bugs" Complaints? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 9
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7
N When is Medical Device Software Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 6
K UDI "Version or Model" for Stand-Alone Medical Device Software US Food and Drug Administration (FDA) 6
Similar threads


















































Top Bottom