指导原则库

CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure

官方主题：Investigation & Enforcement,

Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

关于发布自测用血糖监测系统注册申报资料指导原则的通知

Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff

官方主题：Postmarket, Labeling

Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff

Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Ophthalmic

关于发布植入式心脏起搏器等三个医疗器械产品注册技术审查指导原则的通知

In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff

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

Systemic Lupus Erythematosus --Developing Medical Products for Treatment

官方主题：Clinical - Medical

Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff

官方主题：Premarket,

关于征求《接触镜护理产品技术审评指导原则》意见的通知

关于征求《乳房植入体技术审评指导原则》意见的通知

关于征求《冠状动脉药物洗脱支架临床试验指导原则》意见的通知

关于《无源植入性医疗器械货架寿命指导原则》征求意见的通知

关于《同种异体植入性医疗器械病毒灭活工艺验证指导原则》征求意见的通知

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version)

官方主题：Premarket,

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

官方主题：Biostatistics,

关于征求《植入式心脏起搏器技术指导原则》（征求意见稿）意见的函

New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry

官方主题：Combination Products

无源植入性医疗器械产品注册申报资料指导原则（食药监办械函[2009]519号）

关于印发无源植入性和动物源性医疗器械注册申报资料指导原则的通知

关于征求《影像型超声诊断设备技术指导原则》(征求意见稿)意见的函

Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry

官方主题：Clinical - Medical, Good Clinical Practice (GCP)

Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry

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

关于征求《医用X射线诊断设备技术指导原则》（征求意见稿）意见的函

关于网上征求《自测用血糖监测系统注册申报指导原则》（征求意见稿）意见的通知

肿瘤标志物类定量检测试剂注册申报指导原则（征求意见稿）

Frequently Asked Questions - IRB Registration: Guidance for Institutional Review Boards (IRBs)

官方主题：Good Clinical Practice (GCP)

Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices

官方主题：Food & Color Additives

Presenting Risk Information in Prescription Drug and Medical Device Promotion

官方主题：Advertising

关于印发X射线诊断设备等6个医疗器械产品注册技术审查指导原则的通知

含药医疗器械产品注册申报资料撰写指导原则

人工关节临床试验基本要求（征求意见稿）

人工心脏瓣膜临床试验基本要求（征求意见稿）

冠脉药物洗脱支架临床试验基本要求（征求意见稿）

Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use

官方主题：Postmarket,

Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

官方主题：Premarket, Premarket Approval (PMA)

Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs

官方主题：Good Clinical Practice (GCP)

Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA Staff

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

Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry

官方主题：Advisory Committees, Food & Color Additives