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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR1002.12]
 See Related Information on Abbreviated reports. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J - RADIOLOGICAL HEALTH

PART 1002 -- RECORDS AND REPORTS

Subpart B - Required Manufacturers' Reports for Listed Electronic Products

Sec. 1002.12 Abbreviated reports.

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:

(a) Firm and model identification.

(b) A brief description of operational characteristics that affect radiation emissions, transmission, or leakage or that control exposure.

(c) A list of applications or uses.

(d) Radiation emission, transmission, or leakage levels.

(e) If necessary, additional information as may be requested to determine compliance with the Act and this part.

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