Assertion: device | /r/HasProperty | exempt
Facets:
value: from qsr per regulation
type: OTHER
value: expressly
type: MANNER
Source sentences:
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.