美国医疗器械法规

主管机构：FDA / CDRH · 更新 2026-09-09

44法规与指南条目

318法规动态记录

法规与指南

类型	编号	名称	状态
法规/条例	21 CFR 1	General Enforcement Regulations	in_force
法规/条例	21 CFR 1000	General	in_force
法规/条例	21 CFR 1002	Records and Reports	in_force
法规/条例	21 CFR 1003	Notification of Defects or Failure to Comply	in_force
法规/条例	21 CFR 1005	Importation of Electronic Products	in_force
法规/条例	21 CFR 1010	Performance Standards for Electronic Products: General	in_force
法规/条例	21 CFR 1020	Performance Standards for Ionizing Radiation Emitting Products	in_force
法规/条例	21 CFR 1040	Performance Standards for Light-Emitting Products	in_force
法规/条例	21 CFR 11	Electronic Records; Electronic Signatures	in_force
法规/条例	21 CFR 14	Public Hearing Before a Public Advisory Committee	in_force
法规/条例	21 CFR 16	Regulatory Hearing Before the Food and Drug Administration	in_force
法规/条例	21 CFR 25	Environmental Impact Considerations	in_force
法规/条例	21 CFR 3	Product Jurisdiction	in_force
法规/条例	21 CFR 4	Regulation of Combination Products	in_force
法规/条例	21 CFR 50	Protection of Human Subjects	in_force
法规/条例	21 CFR 54	Financial Disclosure by Clinical Investigators	in_force
法规/条例	21 CFR 56	Institutional Review Boards	in_force
法规/条例	21 CFR 58	Good Laboratory Practice for Nonclinical Laboratory Studies	in_force
法规/条例	21 CFR 7	Enforcement Policy	in_force
法规/条例	21 CFR 801	Labeling	in_force
法规/条例	21 CFR 803	Medical Device Reporting	in_force
法规/条例	21 CFR 806	Medical Devices; Reports of Corrections and Removals	in_force
法规/条例	21 CFR 807	Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices	in_force
法规/条例	21 CFR 809	In Vitro Diagnostic Products for Human Use	in_force
法规/条例	21 CFR 812	Investigational Device Exemptions	in_force
法规/条例	21 CFR 814	Premarket Approval of Medical Devices	in_force
法规/条例	21 CFR 820	Quality Management System Regulation	in_force
法规/条例	21 CFR 821	Medical Device Tracking Requirements	in_force
法规/条例	21 CFR 822	Postmarket Surveillance	in_force
法规/条例	21 CFR 830	Unique Device Identification	in_force
法规/条例	21 CFR 860	Medical Device Classification Procedures	in_force
法规/条例	21 CFR 861	Procedures for Performance Standards Development	in_force
法规/条例	21 CFR 862	Clinical Chemistry and Clinical Toxicology Devices	in_force
法规/条例	21 CFR 864	Hematology and Pathology Devices	in_force
法规/条例	21 CFR 866	Immunology and Microbiology Devices	in_force
法规/条例	21 CFR 870	Cardiovascular Devices	in_force
法规/条例	21 CFR 876	Gastroenterology-Urology Devices	in_force
法规/条例	21 CFR 878	General and Plastic Surgery Devices	in_force
法规/条例	21 CFR 880	General Hospital and Personal Use Devices	in_force
法规/条例	21 CFR 890	Physical Medicine Devices	in_force
法规/条例	21 CFR 892	Radiology Devices	in_force
法规/条例	21 CFR 895	Banned Devices	in_force
法规/条例	21 CFR 900	Mammography	in_force
法规/条例	21 CFR 99	Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices	in_force

法规动态

日期	类型	标题
2026-09-02	new	Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
2026-09-02	guidance	Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
2026-09-02	guidance	Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
2026-08-31	new	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections
2026-08-26	new	Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
2026-08-24	new	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
2026-08-17	consult	Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
2026-08-17	consult	Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
2026-08-17	amend	Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2026-08-10	new	Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri
2026-08-10	consult	Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
2026-08-06	new	Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
2026-08-06	amend	Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
2026-08-03	new	Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
2026-08-03	guidance	Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
2026-07-30	new	Medical Device User Fee Rates for Fiscal Year 2027
2026-07-29	amend	Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
2026-07-27	amend	Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
2026-07-27	amend	Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
2026-07-24	amend	Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
2026-07-24	amend	Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
2026-07-24	amend	Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
2026-07-24	amend	Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
2026-07-23	guidance	Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
2026-07-22	new	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission
2026-07-17	new	Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program
2026-07-17	new	Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
2026-07-17	new	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
2026-07-08	new	Medical Device User Fee Amendments; Public Meeting; Request for Comments
2026-07-06	new	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
2026-06-30	amend	Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
2026-06-30	amend	Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
2026-06-29	amend	Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
2026-06-26	new	Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
2026-06-26	amend	Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
2026-06-26	amend	Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
2026-06-26	amend	Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
2026-06-26	amend	Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
2026-06-26	amend	Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
2026-06-26	amend	Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
2026-06-26	amend	Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
2026-06-22	amend	Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
2026-06-22	amend	Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
2026-06-22	amend	Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
2026-06-17	amend	Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
2026-06-17	amend	Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
2026-06-11	amend	Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
2026-06-11	amend	Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
2026-06-10	amend	Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
2026-06-05	amend	Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
2026-06-05	amend	Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
2026-06-05	new	Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
2026-06-05	amend	Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
2026-06-05	guidance	Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
2026-06-03	new	Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
2026-06-02	guidance	Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry
2026-06-01	amend	Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
2026-06-01	amend	Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
2026-06-01	amend	Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
2026-06-01	amend	Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation

另有 258 条动态记录。