Chapter 3 - Devices - Sub Chapters 355 - 398

  

Sub Chapter 355 - Orthop. and Phy. Med.

• CPG Sec. 355.100 Cellutron Machine - Revoked on 3/10/05
• CPG Sec. 355.200 Electrical Muscle Stimulators
• CPG Sec. 355.300 Ion Generating Devices

Sub Chapter 370 - Immunology

• CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases
• CPG Sec. 370.200 RIA Analysis of Hair to Detect the Prescence of Drugs of Abuse - Revoked

Sub Chapter 390 - 398 - Radiology

• CPG 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
• 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• CPG Sec. 390.500 Definition of "High-Voltage Vacuum Switch" - 21 CFR 1002.61(a)(3) and (b)(2) - withdrawn on 12/07/10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. 393.200 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 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. 398.450 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