Inspections, Compliance, Enforcement, and Criminal Investigations
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Sub Chapters 355 - 398
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Sub Chapter 390 - 398 - Radiology
- Compliance Policy Guide Sec. 390.100 Definition of “Commerce” -21 CFR 1000.3(d) supersedes previously revised version on 03/2005. (PDF - 16KB)
- CPG Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect -21 CFR 1003.11 supersedes previously revised version on 03/1995 (PDF - 45KB)
CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6 CPG Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a) CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 CPG Sec. 390.500 Definition of "High-Voltage Vacuum Switch" - 21 CFR 1002.61(a)(3) and (b)(2) - withdrawn on 12/07/10 CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps - revoked 6/20/02 CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*) CPG Sec. 393.100 Enforcement Policy for Certain Laser Light Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11) CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. CPG Sec. 394.100 Retention of Microwave Oven Test Records CPG Sec. 394.500 Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation during Design Development CPG Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products CPG Sec. 396.200 Exemption for Certain Sunlamp Product Purchaser Records CPG Sec. 396.300 Defective Suntanning Booths and Bed CPG Sec. 396.400 Policy on Warned on Sunlamp Products CPG Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii) CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b) CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray Equipment CPG Sec. 398.350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of Assembly 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 Sec. 398.400 Automatic Adjustment of the X-ray Field Size to the Selected Spot-Film Size - 21 CFR 1020.31(g)(1) CPG Sec. 398.425 Override of Positive Beam Limitation - 21 CFR 1020.31(g)(5) CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System 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 - revoked 11/12/02 CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) CPG Sec. 398.700 Reloaders of X-ray Tube Housing Assemblies; Applicability of Medical Device Establishment Registration, Device Listing and Biennial Inspection
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