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As FDA states in their guidance document on the Q-Submission program, Early interaction with FDA on planned non-clinical and clinical studies and careful consideration of FDAs feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. While this is not meant to be a general pre-review of your submission, it is there to help you get answers to questions directly from FDAwhich will contribute to a smooth submission and, hopefully, approval

2b and Supplementary Table 2)

Singh et al., 2020), enhancing susceptibility to not only LC and CFS but also post viral fatigue syndrome in general, POTS (Blitshteyn, 2017), SIBO, MCAS, EDS, and some MTHFR variants (Okamot et al, 2012)

[2] Watanabe T, Sagisaka H, Arakawa S, Shibaya Y, Wantanabe T, Igarashi I, Tanaka K, Totsuka S, Takasaki W, and Manabe S (2003)

Collins, M