指导原则库

CPG Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products

官方主题：Investigation & Enforcement,

Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems

官方主题：Premarket,

Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology

官方主题：Premarket,

510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments

官方主题：Premarket,

Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters

官方主题：Premarket, Antimicrobial Resistance

Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)

官方主题：Premarket,

Points to Consider for Cervical Cytology Devices

Guidance for the Content of Premarket Notifications for Urine Drainage Bags

官方主题：Premarket, 510(k)

Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement

官方主题：Premarket,

Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products

官方主题：Postmarket, Premarket,

Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators

官方主题：Premarket,

Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

官方主题：Premarket, 510(k)

Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes

官方主题：Premarket, 510(k)

Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43)

官方主题：Radiological Health

Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson

Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes

官方主题：Premarket,

Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities

官方主题：Premarket, 510(k)

Guidance for the Content of Premarket Notifications for Ureteral Stents

官方主题：Premarket,

Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology

官方主题：Premarket,

Compliance Guide for Laser Products (FDA 86-8260)

官方主题：Radiological Health

Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19

官方主题：Premarket, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities

官方主题：Investigation & Enforcement,

CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects

官方主题：Investigation & Enforcement, Administrative / Procedural

Shelf Life of Medical Devices

Device Labeling Guidance #G91-1 (Blue Book Memo)

官方主题：Premarket, Labeling

Quality Assurance Guidelines for Hemodialysis Devices

官方主题：Gastroenterology-Urology

Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42)

官方主题：Radiological Health

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)

CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients

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

CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade Zones

官方主题：Investigation & Enforcement,

CPG Sec. 130.200 Inspection of Firms when Legal Action is Pending

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

CPG Sec. 100.500 - Common Carrier as a Relabeler, Repacker, Reprocessor, etc.

官方主题：Investigation & Enforcement,

CPG Sec. 100.800 Guaranties Over Printed Signatures

官方主题：Investigation & Enforcement, Records

CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers

官方主题：Investigation & Enforcement,

CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation

官方主题：Investigation & Enforcement,

CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States

官方主题：Investigation & Enforcement,

CPG Sec 100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper Products

官方主题：Investigation & Enforcement,

CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling

官方主题：Investigation & Enforcement, Labeling

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2)

官方主题：Radiology

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3)