指导原则库

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 )

官方主题：Radiology

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)

官方主题：Radiology

Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II

官方主题：Premarket, 510(k)

CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets

官方主题：Investigation & Enforcement,

CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity

官方主题：Investigation & Enforcement,

CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis

官方主题：Investigation & Enforcement,

Quality Control Guide for Sunlamp Products (FDA 88-8234)

官方主题：Tanning Lamps, Booths & Beds

Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)

官方主题：Radiological Health

Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40)

官方主题：Laser Notice, Laser Notice

CPG Sec. 160.600 Payment of Expert Witnesses

官方主题：Investigation & Enforcement,

CPG Sec. 345.200 Diaphragms - Rx Devices

官方主题：Investigation & Enforcement, Labeling

CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates

官方主题：Investigation & Enforcement, Safety - Issues, Errors, and Problems

CPG Sec. 300.100 Inspection of Manufacturers of Device Components

官方主题：Investigation & Enforcement,

CPG Sec. 320.100 Ear Piercing Devices

官方主题：Investigation & Enforcement,

CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))

官方主题：Investigation & Enforcement,

CPG Sec. 100.300 *Non-FDA Regulated Products Involving Communicable Disease Hazards*

官方主题：Investigation & Enforcement, Food & Color Additives, Safety - Issues, Errors, and Problems

CPG Sec. 100.100 Responsibility for Reporting Possible or Potential Violations of Laws Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public Health

官方主题：Investigation & Enforcement, Administrative / Procedural, Food & Color Additives

CPG Sec. 100.350 FDA Jurisdiction on Indian Reservations

官方主题：Investigation & Enforcement, Food & Color Additives

User Instructions - Multi Axis Workstations (Laser Notice 39)

Master Files Part III - Guidance on Scientific and Technical Information

官方主题：Premarket,

Color Additive Petitions - Medical Devices

All U.S. Condom Manufacturers, Importers and Repackagers

官方主题：Postmarket, Premarket,

Policy on Lamp Compatibility (sunlamps)

Walk-In Workstations (Laser Notice 37)

Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products

官方主题：Tanning Lamps, Booths & Beds

Policy on Warning Label Required on Sunlamp Products

User Instruction Hazard Warnings (Laser Notice 35)

官方主题：Laser Notice

Medical Laser Delivery System Interlocks (Laser Notice 34)

CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System

官方主题：Investigation & Enforcement, Radiology

Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers

Investigational Medical Laser Significant Risk Device (Laser Notice 31)

官方主题：Laser Notice

CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)

官方主题：Investigation & Enforcement,

CPG Sec 390.100 Definition of “Commerce” - 21 CFR 1000.3(d) 2

官方主题：Investigation & Enforcement,

CPG Sec. 110.500 Food and Drug Guaranty - Imports

官方主题：Investigation & Enforcement,

CPG Sec. 398.400 Automatic Adjustment of the X-ray Field Size to the Selected Spot-Film Size - 21 CFR 1020.31(g)(1)

官方主题：Investigation & Enforcement, Radiology

CPG Sec. 130.100 Inspectional Authority; Refusal to Permit Inspection.

官方主题：Investigation & Enforcement, Food & Color Additives

Alternate Wording For Caution Statement (Laser Notice 30)

官方主题：Radiology

Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25)

官方主题：Radiological Health

Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979: Guidance for Industry

官方主题：Clinical Trials, Compliance, Food & Color Additives, Investigational New Drug Application (INDA), Pharmacology/Toxicology

Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices

官方主题：Premarket,