指导原则库

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry

官方主题：Pharmacology/Toxicology

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

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

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry

官方主题：Administrative / Procedural

Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making

官方主题：Administrative / Procedural

Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors

官方主题：Pediatric Product Development

Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Ophthalmic

General Considerations for Animal Studies Intended to Evaluate Medical Devices: 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

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

官方主题：Premarket, Postmarket, Coronavirus,

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

官方主题：Premarket, Postmarket, Coronavirus,

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff

官方主题：Export, Import, Laser Notice, Radiological Health, Radiology

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Physical Medicine

Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

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

Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide

官方主题：Radiology

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff

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

Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment

Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration Staff

官方主题：Laser Notice, Radiological Health

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff

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

Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff

官方主题：Premarket, Coronavirus, CLIA (Clinical Laboratory Improvement Amendments), Immunology & Microbiology , IVDs (In Vitro Diagnostic Devices)

Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP)

Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Premarket Approval (PMA)

Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff

Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, User Fees, 510(k)

User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, User Fees, Administrative / Procedural

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, User Fees,

User Fees for 513(g) Requests for Information: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, User Fees,

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Administrative / Procedural

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Premarket Approval (PMA)

Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Radiology

Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff

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

Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff

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

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Digital Health

Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs

官方主题：Clinical - Medical, Pediatric Product Development

Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff

官方主题：Laboratory Tests