指导原则库

Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions

官方主题：Premarket,

Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

官方主题：Premarket,

Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry

官方主题：Postmarket, Compliance, Electronic Submissions, Investigation & Enforcement, Administrative / Procedural, Current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP), Food & Color Additives

Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff

官方主题：Postmarket,

Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors

Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff

官方主题：Advisory Committees, Pediatric Product Development

User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry

官方主题：Radiological Health

Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff

官方主题：Premarket, Premarket Approval (PMA)

Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

官方主题：Premarket,

Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers

官方主题：Adverse Event Reporting System (FAERS),

Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA

Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry

官方主题：Premarket,

General Principles of Software Validation: Guidance for Industry and FDA Staff

官方主题：Premarket, Digital Health, Good Clinical Practice (GCP)

Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry

官方主题：Postmarket,

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA

Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff

官方主题：Premarket,

Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry

官方主题：Postmarket,

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

官方主题：Premarket, Investigational Device Exemption (IDE)

Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)

Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff

官方主题：Labeling

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

官方主题：Premarket, Investigational Device Exemption (IDE)

Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers

官方主题：Premarket, Investigational Device Exemption (IDE)

Guidance Document for Dura Substitute Devices - Guidance for Industry

官方主题：Premarket,

Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers

Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry

官方主题：Premarket,

Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff

官方主题：Premarket,

1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers

CPG Sec. 100.950 International Partnership Agreements for Compliance Activities

官方主题：Investigation & Enforcement,

Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses - Guidance for Industry

官方主题：Premarket,

Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry

官方主题：Premarket,

Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff

官方主题：Postmarket,

Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers

官方主题：Premarket, 510(k)

Guidance for the Content of Premarket Notifications for Penile Rigidity Implants - Guidance for Industry and for FDA Staff

官方主题：Premarket, 510(k)

Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff

官方主题：Labeling, Pediatric Product Development

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

官方主题：Premarket, 510(k)

Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff

官方主题：Premarket, Cardiovascular

Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance

官方主题：Premarket,

Recommended Clinical Study Design for Ventricular Tachycardia Ablation

Immunotoxicity Testing Guidance

官方主题：Premarket,

Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff

官方主题：Premarket, Investigational Device Exemption (IDE)