§1002.12. Abbreviated reports.
21 C.F.R. § 1002.12
Manufacturers of products requiring abbreviated reports as specified in table 1 of § 1002.1 shall submit, prior to the introduction of such product, a report distinctly marked “Radiation Safety Abbreviated Report” which shall include:
Firm and model identification.
A brief description of operational characteristics that affect radiation emissions, transmission, or leakage or that control exposure.
A list of applications or uses.
Radiation emission, transmission, or leakage levels.
If necessary, additional information as may be requested to determine compliance with the Act and this part.
Notes, amendments, and revision history
Source
Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.
Authority
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.
Source
Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.