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Warning Letters
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Regulations
Chapter I: Performance Standards for Light-Emitting Products
Chapter I: None
21 CFR 1040.10 - Laser products.
21 CFR 1040.10(g) - (g) Labeling requirements. In addition to the requirements of §§ 1010.2 and 1010.3, each laser p...
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21 CFR 1040.10(f) - (f) Performance requirements —
21 CFR 1040.10(f)(5) - (5) Laser radiation emission indicator.
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21 CFR 1040.10(h) - (h) Informational requirements —
21 CFR 1040.10(h)(1) - (1) User information. Manufacturers of laser products shall provide as an integral part of any u...
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21 CFR 1040.11 - Specific purpose laser products.
21 CFR 1040.11(b) - (b) Surveying, leveling, and alignment laser products. Each surveying, leveling. or alignment la...
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21 CFR 1040.11(a) - (a) Medical laser products. Each medical laser product shall comply with all of the applicable r...
21 CFR 1040.11(a)(1) - (1) Incorporate in each Class III or IV medical laser product a means for the measurement of the ...
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21 CFR 1040.11(a)(3) - (3) Affix to each medical laser product, in close proximity to each aperture through which is emi...
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Part 1002: Records and Reports
Subpart B: Required Manufacturers' Reports for Listed Electronic Products
21 CFR 1002.10 - Product reports.
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21 CFR 1002.13 - Annual reports.
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Subpart C: Manufacturers' Reports on Accidental Radiation Occurrences
21 CFR 1002.20 - Reporting of accidental radiation occurrences.
21 CFR 1002.20(a) - (a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such...
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Part 1003: Notification of Defects or Failure to Comply
Subpart B: Discovery of Defect or Failure To Comply
21 CFR 1003.10 - Discovery of defect or failure of compliance by manufacturer; notice requirements.
21 CFR 1003.10(b) - (b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the fol...
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21 CFR 1003.10 - Discovery of defect or failure of compliance by manufacturer; notice requirements.
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Subpart C: Notification
21 CFR 1003.20 - Notification by the manufacturer to the Secretary.
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Part 1004: Repurchase, Repairs, or Replacement of Electronic Products
Part 1004: None
21 CFR 1004.1 - Manufacturer's obligation to repair, replace, or refund cost of electronic products.
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Part 1010: Performance Standards for Electronic Products: General
Subpart A: General Provisions
21 CFR 1010.4 - Variances.
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21 CFR 1010.2 - Certification.
21 CFR 1010.2(c) - (c) Such certification shall be based upon a test, in accordance with the standard, of the indivi...
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21 CFR 1010.2 - Certification.
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21 CFR 1010.3 - Identification.
21 CFR 1010.3(a) - (a) Every manufacturer of an electronic product to which a standard under this subchapter is appl...
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21 CFR 1010.3 - Identification.
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Part 1020: Performance Standards for Ionizing Radiation Emitting Products
Part 1020: None
21 CFR 1020.30 - Diagnostic x-ray systems and their major components.
21 CFR 1020.30 - Diagnostic x-ray systems and their major components.
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21 CFR 1020.30(d) - (d) Assemblers' responsibility
21 CFR 1020.30(d) - (d) Assemblers' responsibility
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21 CFR 1020.30(d)(1) - (1) Reports of assembly. All assemblers who install certified components shall file a report of ...
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