Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

CFR · 2024-01-01 · US · Title 10

An application for a specific license to manufacture, process, produce, or initially transfer for sale or distribution devices containing byproduct material for use under § 30.22 of this chapter or equivalent regulations of an Agreement State will be approved if: (a) The applicant satisfies the general requirements of § 30.33 of this chapter: However, the requirements of § 30.33(a)(2) and (3) do not apply to an application for a license to transfer byproduct material in such industrial devices manufactured, processed, or produced under a license issued by an Agreement State; (b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the industrial devices to demonstrate that the device will meet the safety criteria set forth in § 32.31. The information should include: (1) A description of the device and its intended use or uses; (2) The type and quantity of byproduct material in each unit; (3) Chemical and physical form of the byproduct material in the device and changes in chemical and physical form that may occur during the useful life of the device; (4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b)(3) and (b)(12) of this section; (5) Details of construction and design of the device as related to containment and shielding of the byproduct material and other safety fe

official document · source cfr-2024 · id 10:§ 32.30