指导原则库

The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Administrative / Procedural

The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Good Clinical Practice (GCP), HUD/HDE, Premarket Approval (PMA)

Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff

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

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff

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

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Premarket Approval (PMA)

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Gastroenterology-Urology

Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff

官方主题：Combination Products

Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff

官方主题：Premarket, Good Clinical Practice (GCP), Pediatric Product Development, Investigational Device Exemption (IDE)

Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff

官方主题：Radiological Health

Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Gastroenterology-Urology

Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration

官方主题：Radiological Health

Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Orthopedic

Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling, UDI

Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff

官方主题：Combination Products

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Laboratory Tests

Release of ORA Laboratory Analytical Results to the Responsible Party: Guidance for Food and Drug Administration Staff

官方主题：Investigation & Enforcement, Administrative / Procedural

Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry

官方主题：Combination Products, Gene Therapy

Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C : Guidance for Industry and FDA Staff

官方主题：Recalls, Investigation & Enforcement,

The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff

官方主题：Premarket,

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：IVDs (In Vitro Diagnostic Devices), Premarket Approval (PMA), Testing

Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket Approval (PMA)

Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards

官方主题：Good Clinical Practice (GCP)

Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry

官方主题：Chemistry, Manufacturing, and Controls (CMC), Combination Products, Pharmaceutical Quality

Compliance Policy Guides Index

官方主题：Investigation & Enforcement,

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff

官方主题：510(k)

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Premarket Approval (PMA), HUD/HDE, Combination Products

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Administrative / Procedural

Osteoarthritis: Structural Endpoints for the Development of Drugs

官方主题：Clinical - Medical

Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry

官方主题：Administrative / Procedural

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Digital Health

Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry

官方主题：Administrative / Procedural

Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff

官方主题：Premarket, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Molecular and Clinical Genetics

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

官方主题：Administrative / Procedural

E18 Genomic Sampling and Management of Genomic Data Guidance for Industry

官方主题：ICH-Efficacy

Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Good Clinical Practice (GCP), Investigational Device Exemption (IDE)

Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff

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

Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards

官方主题：Good Clinical Practice (GCP), Labeling, Investigational Device Exemption (IDE), Investigational New Drug Application (INDA), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)