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We have been asked to "classify" for FDA purposes a piece of software written for an OTC software package (not ours).
Please try to follow my thoughts and let me know if there are any flaws:
1) OTC SW is defined in FDA MDDS as "Standard IT software that is not specifically sold by the manufacturer as a MDDS, which may have MDDS functionality such as reading serial numbers, barcodes, UDI or other data from a medical device, but is not used in providing patient care."
2) We add to the OTC SW our plug-in that provides a measuring function for displayed medical data (ECG), according to FDA this addition of modifying data/display of data disallows MDDS classification (FDA - An MDDS does not modify the data or modify the display of the data).
3) So by the way of adding the plug-in, have we turned the OTC SW into a medical device?
My conclusion: OTC SW (for reading ECG PDFs) + plug-in (for performing and saving measurements on ECG PDF) = modifcation of data/display of data and is used in providing patient care = medical device!
Please try to follow my thoughts and let me know if there are any flaws:
1) OTC SW is defined in FDA MDDS as "Standard IT software that is not specifically sold by the manufacturer as a MDDS, which may have MDDS functionality such as reading serial numbers, barcodes, UDI or other data from a medical device, but is not used in providing patient care."
2) We add to the OTC SW our plug-in that provides a measuring function for displayed medical data (ECG), according to FDA this addition of modifying data/display of data disallows MDDS classification (FDA - An MDDS does not modify the data or modify the display of the data).
3) So by the way of adding the plug-in, have we turned the OTC SW into a medical device?
My conclusion: OTC SW (for reading ECG PDFs) + plug-in (for performing and saving measurements on ECG PDF) = modifcation of data/display of data and is used in providing patient care = medical device!

