指导原则库

Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff

Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Ophthalmic, Premarket Approval (PMA)

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration Staff

官方主题：Ebola,

Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

官方主题：Premarket, Ophthalmic

Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff

官方主题：Administrative / Procedural, Pediatric Product Development

Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Molecular and Clinical Genetics, Immunology & Microbiology

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Premarket Approval (PMA)

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff

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

Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff

官方主题：Radiological Health

Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket,

Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

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

Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling, UDI

FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff

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

Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling

In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff

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

Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for Industry

官方主题：Premarket, Food & Color Additives, Records

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

官方主题：Advertising

Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP)

Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff

官方主题：Premarket, Pediatric Product Development

Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff

官方主题：Premarket,

The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor: Questions and Answers: Guidance for Industry, Consumers, and FDA Staff

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

Medical Device Tracking : Guidance for Industry and FDA Staff

Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff

官方主题：Premarket, Pediatric Product Development

Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff

官方主题：Advisory Committees, Food & Color Additives

Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff

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

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

官方主题：Premarket, Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff

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

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff

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

Electronic Source Data in Clinical Investigations: Guidance for Industry

官方主题：Administrative / Procedural, Good Clinical Practice (GCP)

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors

官方主题：Administrative / Procedural, Good Clinical Practice (GCP)

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

官方主题：Premarket, Digital Health