Assertion: medical device | /r/HasProperty | intended for commercial distribution
Facets:
value: in the united states
type: LOCATION
Source sentences:
text: Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are required to register annually with the FDA.
text: Establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register with the FDA.
text: They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States, unless such device is expressly exempt from QSR per regulation, which would be identified in specific classification regulations in 21 CFR parts 862-892.