指导原则库

Guidance on 510(k) Submissions for Keratoprostheses - Guidance for Industry and for FDA Reviewers/Staff

官方主题：Premarket,

Guidance for Dermabrasion Devices - Guidance for Industry

官方主题：Premarket,

Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

官方主题：Clinical - Medical

Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff

官方主题：Premarket,

Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry

官方主题：Premarket, Radiology

Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry

官方主题：Premarket,

Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1 - Guidance for Industry

官方主题：Premarket,

Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff

官方主题：Premarket,

Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical Investigators

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

FDA Animal Products Database Data Entry Form

Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry

官方主题：Premarket, Cardiovascular

Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry

官方主题：Premarket,

General/Specific Intended Use - Guidance for Industry

官方主题：Premarket, Pediatric Product Development

Noise Claims in Hearing Aid Labeling - Guidance for Industry

官方主题：Premarket,

Guidance Document For Nonprescription Sunglasses - Guidance for Industry

官方主题：Premarket,

Guidance Document for Powered Suction Pump 510(k)s - Guidance for Industry and FDA Reviewers/Staff

OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA Staff

官方主题：Premarket,

Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies

官方主题：Radiological Health

Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff

官方主题：Premarket,

Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry

官方主题：Premarket, 510(k)

Uniform Contraceptive Labeling - Guidance for Industry

官方主题：Premarket,

Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices

官方主题：Premarket,

Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review : Guidance for Industry

官方主题：Premarket,

Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry

官方主题：Premarket,

Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff

官方主题：Premarket,

Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Use of Investigational Products When Subjects Enter a Second Institution: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Cooperative Research: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Screening Tests Prior to Study Enrollment: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP)

Industry-Supported Scientific and Educational Activites

官方主题：Administrative / Procedural, Advertising

Direct Final Rule Procedures: Guidance for FDA and Industry

官方主题：Administrative / Procedural

Industry Supported Scientific and Educational Activities: Guidance for Industry

官方主题：Administrative / Procedural

Kit Certification for 510(k)s

官方主题：Premarket,

Convenience Kits Interim Regulatory Guidance

官方主题：Premarket,

Non-Invasive Blood Pressure (NIBP) Monitor Guidance

官方主题：Premarket,

Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5

官方主题：Premarket,

510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants

官方主题：Premarket,