Healthcare Authority Regulatory Oversight
UK Healthcare Authority Regulatory OversightIn 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