§35.49. Suppliers for sealed sources or devices for medical use. — Inbound Citations

10 C.F.R. § 35.49

Statutory Authority

Cited by 4 regulations in release Current.

10 C.F.R. § 35.15(g)

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(g) The provisions of § 35.49(a).
10 C.F.R. § 35.400(b)

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(b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
10 C.F.R. § 35.500(c)

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(c) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.
10 C.F.R. § 35.600(a)(2)

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(2) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.