Stream: devices
Topic: FDA Guidance Finalized
Todd Cooper (Aug 04 2020 at 13:57):
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-device-products-policy-and-considerations that will include products that are partly SAMD (regulated medical devices) but that also incorporate "other" non-medical device functions. Relates directly to those FHIR-enabled applications that include, for example, AI-based capabilities that fall on both "sides" of the FDA regulatory line.
Last updated: Apr 12 2022 at 19:14 UTC
