指导原则库

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

官方主题：Advertising

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry

官方主题：Combination Products, Pediatric Product Development

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry

官方主题：Pediatric Product Development

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry

官方主题：Postmarket, Investigation & Enforcement,

Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff

官方主题：Labeling

Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff

Use of Data Monitoring Committees in Clinical Trials

官方主题：Clinical - Medical

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

官方主题：Clinical - Medical, Pediatric Product Development

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Orthopedic

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

官方主题：Clinical - Medical

Translation of Good Laboratory Practice Study Reports: Questions and Answers

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Export, Import

Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：HUD/HDE, Premarket Approval (PMA)

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Radiological Health, Radiology

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Labeling, Safety - Issues, Errors, and Problems

Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Combination Products, Clinical - Medical, Digital Health

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff

官方主题：Antimicrobial Resistance

Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment

Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies

官方主题：Emergencies,

Regulatory Considerations for Prescription Drug Use-Related Software

官方主题：Labeling

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Current Good Manufacturing Practice (CGMP)

Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Safety - Issues, Errors, and Problems

Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff

官方主题：Combination Products

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Coronavirus, Labeling

Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP), Pediatric Product Development

Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Ophthalmic

Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff

官方主题：Premarket, Administrative / Procedural, Digital Health

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program: Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff

Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Clinical - Medical, General & Plastic Surgery , Obstetrical & Gynecological