指导原则库

Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors

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

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

官方主题：Premarket, 510(k)

Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA Staff

官方主题：Postmarket,

Using Electronic Means to Distribute Certain Product Information: Guidance for Industry

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

Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff

官方主题：Premarket,

Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry

官方主题：Administrative / Procedural

Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff

Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP), Investigational Device Exemption (IDE)

Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP)

CPG Sec. 160.100 Regulatory Actions and Small Business

官方主题：Investigation & Enforcement,

Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)

Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff

官方主题：Postmarket, Cardiovascular

Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff

官方主题：Premarket,

Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)

官方主题：Investigation & Enforcement, Dental

CPG Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier

官方主题：Investigation & Enforcement,

CPG Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products

官方主题：Investigation & Enforcement, Administrative / Procedural

Pharmacogenomic Data Submissions: Guidance for Industry

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

CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a)

官方主题：Investigation & Enforcement, Administrative / Procedural

CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b)

官方主题：Investigation & Enforcement, Radiology

CPG Sec. 396.300 Defective Suntanning Booths and Bed

官方主题：Investigation & Enforcement,

CPG Sec. 398.700 Reloaders of X-ray Tube Housing Assemblies; Applicability of Medical Device Establishment Registration, Device Listing and Biennial Inspection

官方主题：Investigation & Enforcement,

CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray Equipment

官方主题：Investigation & Enforcement,

CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy

官方主题：Investigation & Enforcement,

Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff

官方主题：Premarket,

CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention

官方主题：Investigation & Enforcement, Records

Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff

官方主题：Premarket,

Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)

官方主题：Premarket,

The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators

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

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff

官方主题：User Fees, 510(k)

Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version)

官方主题：Premarket,

Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff

官方主题：Combination Products

Guidance for Industry and FDA Staff: Spinal System 510(k)s

官方主题：Premarket,

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

官方主题：Premarket,

Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions

官方主题：Premarket,

Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

官方主题：Premarket,

Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry

官方主题：Postmarket, Compliance, Electronic Submissions, Investigation & Enforcement, Administrative / Procedural, Current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP), Food & Color Additives

Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff

官方主题：Postmarket,

Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors

Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff

官方主题：Advisory Committees, Pediatric Product Development