SaMD Decision Tree

Is Your Spectroscopy Software a Medical Device?

Answer six questions to determine your FDA classification and regulatory obligations.

Demonstration only. This tool is for educational and illustrative purposes. Do not use its output for clinical, diagnostic, regulatory, or any decision-making purposes. LumenMark LLC assumes no responsibility for any actions taken based on tool outputs. Full disclaimer

Question 1 of 60%

Question 1

Is Your Spectroscopy Software a Medical Device?

Does your software acquire or process spectral data from a medical device?