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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: 21CFR1010.13]
See Related Information on Special test procedures. 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 1010 -- PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

Subpart B - Alternate Test Procedures

Sec. 1010.13 Special test procedures.

The Director, Center for Devices and Radiological Health, may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this subchapter for an electronic product if he determines that such products are not susceptible to satisfactory testing by the procedures set forth in the standard and that the alternative test procedures assure compliance with the standard.

[40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]

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