指导原则库

Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA Staff

官方主题：Advisory Committees, Food & Color Additives

Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA Staff

官方主题：Postmarket,

Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA Staff

官方主题：Postmarket,

Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

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

Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff

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

Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry

官方主题：Postmarket, Administrative / Procedural

Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Medical Glove Guidance Manual: Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

一次性使用透析器产品注册申报资料指导原则（征求意见稿）

关于《一次性使用输注器具产品注册申报资料指导原则》等3个文件征求意见的通知

齿科种植体（系统）产品注册申报资料指导原则（征求意见稿）

一次性使用输注器具产品注册申报资料指导原则（征求意见稿）

含药医疗器械产品注册申报资料撰写指导原则（征求意见稿）

关于《无源植入性医疗器械产品注册申报资料撰写指导原则》等3个文件征求意见的通知

动物源性医疗器械产品注册申报资料撰写指导原则（征求意见稿）

无源植入性医疗器械产品注册申报资料撰写指导原则（征求意见稿）

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A

官方主题：Postmarket,

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests

Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)

Compliance Guide for Cabinet X-Ray Systems

Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff

官方主题：Premarket,

Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff

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

关于征求《体外诊断试剂生产及质量控制技术指导原则（征求意见稿）》意见的函

Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff

官方主题：Postmarket, Radiological Health

Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA Staff

官方主题：Combination Products

关于印发医疗器械生物学评价和审查指南的通知

Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff

官方主题：Premarket,

Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff

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

CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections

官方主题：Investigation & Enforcement,

关于开展体外循环管道类产品再评价工作的通知

关于印发高强超声聚焦治疗机有关技术要求的通知

关于含有牛、羊源性材料医疗器械注册有关事宜的公告

Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

官方主题：Premarket,

Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff

官方主题：Biostatistics,

Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry

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

Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors

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

Decorative, Non-corrective Contact Lenses: Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers