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§895.22. Submission of data and information by the manufacturer, distributor, or importer. — Inbound Citations

21 C.F.R. § 895.22

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 895.22 as a whole

  • (3) In determining whether a device presents deception or risk of illness or injury, the Commissioner will consider all available data and information, including data and information that the Commissioner may obtain under other provisions of the act, data and information that may be supplied by the manufacturer, distributor, or importer of the device under § 895.22, and data and information voluntarily submitted by any other interested persons.