Healthcare Authority Regulatory Oversight

• UK Healthcare Authority Regulatory Oversight

  In the UK there are 2 primary healthcare authorities that provide regulatory oversight. These are: Care Quality Commission (CQC) for clinical tests Medicines and Healthcare products Regulatory Agency (MHRA) for medication and devices The Biomesight gut microbiome test does not fall into either o...

• Why is there an FDA disclaimer?

  In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered. https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests