指导原则库

Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, General & Plastic Surgery

Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Electronic Submissions, Premarket Approval (PMA)

Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Safety - Issues, Errors, and Problems

Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Gastroenterology-Urology

Submitting Next-Generation Sequencing Data to the Division of Antiviral Products

官方主题：Technical Specifications

Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry

官方主题：Administrative / Procedural

Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Safety - Issues, Errors, and Problems

Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Orthopedic

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties

Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry

官方主题：Investigation & Enforcement, Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality

Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Gastroenterology-Urology

Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Current Good Manufacturing Practice (CGMP), Digital Health

Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff

官方主题：Administrative / Procedural, Digital Health

Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Cardiovascular

Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry

General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry

官方主题：Clinical Trials, Compliance, Postmarket, Premarket, Investigation & Enforcement, Inspection, International, Administrative / Procedural, Bioequivalence, Biopharmaceutics, Biosimilars, Investigational New Drug Application (INDA), Food & Color Additives, Generic Drugs, HUD/HDE, Investigational Device Exemption (IDE), Premarket Approval (PMA), IVDs (In Vitro Diagnostic Devices), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Vaccines

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE),

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry

官方主题：Device & Drug Safety

Study of Sex Differences in the Clinical Evaluation of Medical Products

官方主题：Clinical - Medical

eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, User Fees, Administrative / Procedural, Investigational Device Exemption (IDE)

Cross-Center Master Files: Where to Submit: Draft Guidance for Industry

How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry

官方主题：Combination Products

Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Obstetrical & Gynecological

Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Current Good Manufacturing Practice (CGMP), HUD/HDE, Premarket Approval (PMA)

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

官方主题：Administrative / Procedural, Pediatric Product Development

Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff

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

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Digital Health

Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

官方主题：User Fees, Administrative / Procedural

Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry

Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry

官方主题：Compliance, Investigation & Enforcement, Inspection, Electronic Submissions, Regulation, Administration, Records, Import

Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：510(k), General & Plastic Surgery , Labeling

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff

官方主题：Administrative / Procedural, Investigational Device Exemption (IDE)