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Inspections, Compliance, Enforcement, and Criminal Investigations
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Sub Chapters 355 - 398
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Sub Chapter 355 - Orthop. and Phy. Med.
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Sub Chapter 370 - Immunology
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Sub Chapter 390 - 398 - Radiology
- CPG Sec. 390.100 Definition of "Commerce" - 21 CFR 1000.3(d) (CPG 7133.02)
- CPG Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 (CPG 7133.05)
- CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6 (CPG 7133.06)
- CPG Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products (CPG 7133.23)
- CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a) (CPG 7133.01)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (CPG 7133.07)
- CPG Sec. 390.500 Definition of "High-Voltage Vacuum Switch" - 21 CFR 1002.61(a)(3) and (b)(2) CPG 7133.04
- CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13)
- CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (Revoked effective 06/20/2002) (CPG 7133.13)
- CPG Sec. 393.100 Enforcement Policy for Certain Laser Light Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11) (CPG 7133.10)
- CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)
- CPG Sec. 394.100 Retention of Microwave Oven Test Records (CPG 7133.19)
- CPG Sec. 394.500 Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation (CPG 7133.22)
- CPG Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products (CPG 7133.16)
- CPG Sec. 396.200 Exemption for Certain Sunlamp Product Purchaser Records (CPG 7133.18)
- CPG Sec. 396.300 Defective Suntanning Booths and Bed (CPG 7133.24)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (CPG 7133.29)
- CPG Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii) (CPG 7133.14)
- CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b) (CPG 7133.11)
- CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems (CPG 7133.25)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (CPG 7124.14)
- CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray Equipment (CPG 7133.12)
- CPG Sec. 398.350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of Assembly (CPG 7133.28)
- CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray Equipment (CPG 7133.27)
- CPG Sec. 398.400 Automatic Adjustment of the X-ray Field Size to the Selected Spot-Film Size - 21 CFR 1020.31(g)(1) (CPG 7133.09)
- CPG Sec. 398.425 Override of Positive Beam Limitation - 21 CFR 1020.31(g)(5) (CPG 7133.08)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (CPG 7133.26)
- CPG Sec. 398.475 Minimum X-ray Field Size for Spot-Film Operation of Fluoroscopic Systems with Fixed SID and Without Stepless Adjustment of the Field Size (CPG 7133.17)
- CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) (CPG 7133.03)
- CPG Sec. 398.700 Reloaders of X-ray Tube Housing Assemblies; Applicability of Medical Device Establishment Registration, Device Listing and Biennial Inspection (CPG 7133.20)
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