New Tool

QMSR Gap Analysis Tool: Assess your QMS compliance efficiently with our guided wizard

CFR Decoded by LENS

The Smartest way to navigate FDA medical device regulations

The Smartest way to navigate FDA medical device regulations

Part 800—General

Subpart A [Reserved]

Subpart B—Requirements for Specific Medical Devices

Subpart C—Administrative Practices and Procedures

Part 801—Labeling

Subpart A—General Labeling Provisions

Subpart B—Labeling Requirements for Unique Device Identification

Subpart C—Labeling Requirements for Over-the-Counter Devices

Subpart D—Exemptions From Adequate Directions for Use

Subpart E—Other Exemptions

Subparts F-G [Reserved]

Subpart H—Special Requirements for Specific Devices

Part 803—Medical Device Reporting

Subpart A—General Provisions

Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports

Subpart C—User Facility Reporting Requirements

Subpart D—Importer Reporting Requirements

Subpart E—Manufacturer Reporting Requirements

Part 806—Medical Devices; Reports of Corrections and Removals

Subpart A—General Provisions

Subpart B—Reports and Records

Part 807—Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Subpart A—General Provisions

Subpart B—Procedures for Device Establishments

Subpart C—Procedures for Foreign Device Establishments

Subpart D—Exemptions

Subpart E—Premarket Notification Procedures

Part 808—Exemptions from Federal Preemption of State and Local Medical Device Requirements

Subpart A—General Provisions

Subpart B—Exemption Procedures

Subpart C—Listing of Specific State and Local Exemptions

Part 809—In Vitro Diagnostic Products for Human Use

Subpart A—General Provisions

Subpart B—Labeling

Subpart C—Requirements for Manufacturers and Producers

Part 810—Medical Device Recall Authority

Subpart A—General Provisions

Subpart B—Mandatory Medical Device Recall Procedures

Part 812—Investigational Device Exemptions

Subpart A—General Provisions

Subpart B—Application and Administrative Action

Subpart C—Responsibilities of Sponsors

Subpart D—IRB Review and Approval

Subpart E—Responsibilities of Investigators

Subpart F [Reserved]

Subpart G—Records and Reports

Part 813 [Reserved]

Part 814—Premarket Approval of Medical Devices

Subpart A—General

Subpart B—Premarket Approval Application (PMA)

Subpart C—FDA Action on a PMA

Subpart D—Administrative Review [Reserved]

Subpart E—Postapproval Requirements

Subparts F-G [Reserved]

Subpart H—Humanitarian Use Devices

Part 820—Quality System Regulation

Subpart A—General Provisions

Subpart B—Quality System Requirements

Subpart C—Design Controls

Subpart D—Document Controls

Subpart E—Purchasing Controls

Subpart F—Identification and Traceability

Subpart G—Production and Process Controls

Subpart H—Acceptance Activities

Subpart I—Nonconforming Product

Subpart J—Corrective and Preventive Action

Subpart K—Labeling and Packaging Control

Subpart L—Handling, Storage, Distribution, and Installation

Subpart M—Records

Subpart N—Servicing

Subpart O—Statistical Techniques

Part 821—Medical Device Tracking Requirements

Subpart A—General Provisions

Subpart B—Tracking Requirements

Subpart C—Additional Requirements and Responsibilities

Subpart D—Records and Inspections

Part 822—Postmarket Surveillance

Subpart A—General Provisions

Subpart B—Notification

Subpart C—Postmarket Surveillance Plan

Subpart D—FDA Review and Action

Subpart E—Responsibilities of Manufacturers

Subpart F—Waivers and Exemptions

Subpart G—Records and Reports

Part 830—Unique Device Identification

Subpart A—General Provisions

Subpart B—Requirements for a Unique Device Identifier

Subpart C—FDA Accreditation of an Issuing Agency

Subpart D—FDA as an Issuing Agency

Subpart E—Global Unique Device Identification Database

Part 860—Medical Device Classification Procedures

Subpart A—General

Subpart B—Classification

Subpart C—Reclassification

Subpart D—De Novo Classification

Part 861—Procedures for Performance Standards Development

Subpart A—General

Subpart B—Procedures for Performance Standards Development and Publication

Part 862—Clinical Chemistry and Clinical Toxicology Devices

Subpart A—General Provisions

Subpart B—Clinical Chemistry Test Systems

Subpart C—Clinical Laboratory Instruments

Subpart D—Clinical Toxicology Test Systems

Part 864—Hematology and Pathology Devices

Subpart A—General Provisions

Subpart B—Biological Stains

Subpart C—Cell And Tissue Culture Products

Subpart D—Pathology Instrumentation and Accessories

Subpart E—Specimen Preparation Reagents

Subpart F—Automated and Semi-Automated Hematology Devices

Subpart G—Manual Hematology Devices

Subpart H—Hematology Kits and Packages

Subpart I—Hematology Reagents

Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products

Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Part 866—Immunology and Microbiology Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C—Microbiology Devices

Subpart D—Serological Reagents

Subpart E—Immunology Laboratory Equipment and Reagents

Subpart F—Immunological Test Systems

Subpart G—Tumor Associated Antigen immunological Test Systems

Part 868—Anesthesiology Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C—Monitoring Devices

Subparts D-E [Reserved]

Subpart F—Therapeutic Devices

Subpart G—Miscellaneous

Part 870—Cardiovascular Devices

Subpart A—General Provisions

Subpart B—Cardiovascular Diagnostic Devices

Subpart C—Cardiovascular Monitoring Devices

Subpart D—Cardiovascular Prosthetic Devices

Subpart E—Cardiovascular Surgical Devices

Subpart F—Cardiovascular Therapeutic Devices

Part 872—Dental Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C [Reserved]

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Subpart F—Therapeutic Devices

Subpart G—Miscellaneous Devices

Part 874—Ear, Nose, and Throat Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C [Reserved]

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Subpart F—Therapeutic Devices

Part 876—Gastroenterology-Urology Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C—Monitoring Devices

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Subpart F—Therapeutic Devices

Part 878—General and Plastic Surgery Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C [Reserved]

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Subpart F—Therapeutic Devices

Part 880—General Hospital and Personal Use Devices

Subpart A—General Provisions

Subpart B [Reserved]

Subpart C—General Hospital and Personal Use Monitoring Devices

Subparts D-E [Reserved]

Subpart F—General Hospital and Personal Use Therapeutic Devices

Subpart G—General Hospital and Personal Use Miscellaneous Devices

Part 882—Neurological Devices

Subpart A—General Provisions

Subpart B—Neurological Diagnostic Devices

Subparts C-D [Reserved]

Subpart E—Neurological Surgical Devices

Subpart F—Neurological Therapeutic Devices

Part 884—Obstetrical and Gynecological Devices

Subpart A—General Provisions

Subpart B—Obstetrical and Gynecological Diagnostic Devices

Subpart C—Obstetrical and Gynecological Monitoring Devices

Subpart D—Obstetrical and Gynecological Prosthetic Devices

Subpart E—Obstetrical and Gynecological Surgical Devices

Subpart F—Obstetrical and Gynecological Therapeutic Devices

Subpart G—Assisted Reproduction Devices

Part 886—Ophthalmic Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C [Reserved]

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Subpart F—Therapeutic Devices

Part 888—Orthopedic Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subpart C [Reserved]

Subpart D—Prosthetic Devices

Subpart E—Surgical Devices

Part 890—Physical Medicine Devices

Subpart A—General Provisions

Subpart B—Physical Medicine Diagnostic Devices

Subpart C [Reserved]

Subpart D—Physical Medicine Prosthetic Devices

Subpart E [Reserved]

Subpart F—Physical Medicine Therapeutic Devices

Part 892—Radiology Devices

Subpart A—General Provisions

Subpart B—Diagnostic Devices

Subparts C-E [Reserved]

Subpart F—Therapeutic Devices

Subpart G—Miscellaneous Devices

Part 895—Banned Devices

Subpart A—General Provisions

Subpart B—Listing of Banned Devices

Part 898—Performance Standard for Electrode Lead Wires and Patient Cables

§ 898.11 Applicability.

§ 898.12 Performance standard.

§ 898.13 Compliance dates.

§ 898.14 Exemptions and variances.

QMSR Gap Analysis Tool

Assess QMS compliance across 94 requirements • Export PDF reports

Select a Section

Browse the hierarchy on the left or use the search bar above to find specific regulations.