- Is the FDA clearing the way for 23andMe and competitors? A Federal Register entry shows “866.5950 Genetic Health Risk Assessment System” as having an exemption if the FDA has already received “first time FDA marketing authorization.” This may be wording that would allow 23andMe to operate without having to get separate clearances for every single condition.
- On November 17, 2017 from 1:30 – 3:00 PM, EST, FDA will host the first in a series of webinars on the Digital Health Precertification (Pre-Cert) Pilot Program. The webinar will be available at this link with the conference code: PWXW6073476.
Source: FDA Website