指导原则库

Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff

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

Data Standards Catalog

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

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

Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators

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

Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff

官方主题：Premarket,

Developing Drugs for Optical Imaging

官方主题：Clinical - Medical

Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Pediatric Product Development

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket,

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Digital Health

Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties

官方主题：Artificial Intelligence

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers

官方主题：Administrative / Procedural

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：IVDs (In Vitro Diagnostic Devices)

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices

官方主题：Clinical - Medical

Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff

官方主题：GUDID, Labeling, UDI

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff

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

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Orthopedic

Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Orthopedic

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

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

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry

官方主题：Clinical - Medical, Pediatric Product Development

Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff

官方主题：Export, Import, Labeling, Radiology

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Chemistry, Manufacturing, and Controls (CMC)

Conducting Clinical Trials With Decentralized Elements

官方主题：Clinical - Medical

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff

官方主题：Investigation & Enforcement, Administrative / Procedural, Radiological Health, Radiology

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Administrative / Procedural, Labeling

Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Electronic Submissions,

Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

官方主题：Premarket,

Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff

Application User Fees for Combination Products: Guidance for Industry and FDA Staff

官方主题：User Fees, Combination Products, Pediatric Product Development

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration Staff