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42 CFR 84.65

§ 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; public demonstrations.

United States · 42 CFR — Public Health · Status: effective

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42 CFR 84.65, § 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; public demonstrations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/201684
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(a) All examinations, inspections, and tests conducted pursuant to subparts H through O of this part will be under the sole direction and control of the Institute. (b) The Institute may, as a condition of approval, require the assistance of the applicant or agents of the applicant during the assembly, disassembly, or preparation of any respirator or respirator component prior to testing or in the operation of such equipment during testing. (c) Only Institute personnel, persons assisting the Institute pursuant to paragraph (b) of this section, and such other persons as are requested by the Institute or the applicant to be observers, shall be present during any examination, inspection, or test conducted prior to the issuance of an approval by the Institute for the equipment under consideration. (d) The Institute shall hold as confidential any analyses, drawings, specifications, or materials submitted by the applicant and shall not disclose any principles or patentable features of such equipment, except as required by statute or regulation. (e) As a condition of each approval issued for any respirator, the Institute reserves the right, following the issuance of such approval, to conduct such public tests and demonstrations of the approved respiratory equipment as is deemed appropriate.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.