指导原则库

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

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

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)

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)

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

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,

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

CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices

官方主题：Investigation & Enforcement,

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff

官方主题：Combination Products

Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses

官方主题：Food & Color Additives

Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff

官方主题：Postmarket, User Fees, Labeling

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff

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