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Orthopedic Devices
21 CFR Part 888 establishes FDA classification and regulatory requirements for orthopedic devices intended for human use in commercial distribution. Devices classified as Class III require premarket approval (PMA) or completed product development protocol (PDP) before marketing, with specific effective dates and grace periods outlined. Manufacturers must demonstrate substantial equivalence to existing devices via premarket notification submissions.
Medical Device Recall Authority
21 CFR Part 810 establishes FDA procedures for exercising medical device recall authority under the Federal Food, Drug, and Cosmetic Act. It defines key terms including recall, correction, removal, serious adverse health consequences, and unique device identifiers, and outlines requirements for cease distribution orders and mandatory recall strategies applicable to device manufacturers, distributors, and user facilities.
Labeling
FDA regulation 21 CFR Part 801 establishes labeling requirements for medical devices in package form. Manufacturers, packers, and distributors must conspicuously display their name and place of business (including street address, city, state, and ZIP code) on device labels. Labels must clarify the relationship between the labeled entity and the device (e.g., "Manufactured for", "Distributed by"). The regulation defines key terms including implantable devices, finished devices, expiration dates, and automatic identification and data capture (AIDC) technology for unique device identification.
Radiology Devices
21 CFR Part 892 establishes the regulatory framework for radiology devices intended for human use in commercial distribution. The regulation sets out device classification requirements, premarket approval procedures, and exemption limitations. Manufacturers must demonstrate substantial equivalence to existing devices and comply with FDA approval requirements based on device class, with specific grace periods and effective dates governing commercial distribution of new or substantially altered radiology devices.
Anesthesiology Devices
21 CFR Part 868 establishes the FDA classification framework for anesthesiology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements for Class III devices, defines substantial equivalence standards for premarket notification submissions, and specifies effective dates for FDA approval orders. Manufacturers must demonstrate substantial equivalence to existing devices or obtain premarket approval (PMA) or product development protocol (PDP) clearance before commercial distribution.
Medical Device Tracking Requirements
21 CFR Part 821 establishes mandatory tracking requirements for class II and III medical devices that meet FDA criteria, including those likely to cause serious adverse health consequences, implanted for over one year, or used as life-sustaining/supporting devices outside facilities. Manufacturers must trace devices from production through distributors to patients; failure to comply constitutes misbranding and a prohibited act. Manufacturers bear primary responsibility and must notify FDA if discontinuing business, with tracking records transferred or responsibility reassigned in writing.
Immunology and Microbiology Devices
21 CFR Part 866 establishes the regulatory classification framework for immunology and microbiology devices intended for human use in commercial distribution. The regulation defines scope, premarket approval requirements, and effective dates for Class III devices, requiring FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976.
Procedures for Performance Standards Development
21 CFR Part 861 establishes procedures for FDA development of performance standards for Class II and Class III medical devices. Standards address device performance characteristics, design, manufacturing processes, quality control, testing requirements, labeling, and distribution restrictions to ensure safety and effectiveness. The FDA coordinates with other federal agencies and stakeholder organizations in standard-setting.
In Vitro Diagnostic Products for Human Use
21 CFR Part 809 establishes regulatory requirements for in vitro diagnostic (IVD) products intended for human use, including reagents, instruments, and systems used to diagnose disease or determine health status. The regulation defines IVD products as medical devices under the Federal Food, Drug, and Cosmetic Act, specifies labeling requirements including proprietary name, intended use, ingredient declarations, warnings, and storage instructions, and addresses confidentiality of submitted data. Requirements vary by product class and may include prescription restrictions and hazard-specific precautions.
Neurological Devices
21 CFR Part 882 establishes the FDA regulatory framework for neurological devices intended for human use in commercial distribution. The regulation sets forth device classification requirements and premarket approval procedures, specifying that class III neurological devices require FDA premarket approval (PMA) or completed product development protocol (PDP) before commercial distribution, with grace periods for devices marketed before May 28, 1976, but not for new devices introduced after that date.
Ear, Nose, and Throat Devices
21 CFR Part 874 establishes FDA classification and regulatory requirements for ear, nose, and throat (ENT) medical devices intended for human use in commercial distribution. The regulation outlines premarket approval procedures, including requirements for Class III devices to obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercialization, with specified grace periods for devices marketed before May 28, 1976, and mandatory immediate approval for new or substantially altered devices.
Licensing
21 CFR Part 601 establishes procedures for obtaining biologics licenses from the FDA for biological products including therapeutic DNA plasmids, synthetic peptides, monoclonal antibodies, and recombinant DNA-derived products. Applicants must submit comprehensive safety, purity, and potency data from nonclinical and clinical studies, manufacturing information, stability data, labeling specimens, and environmental assessments to the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
21 CFR Part 607 establishes establishment registration and product listing requirements for manufacturers of human blood and blood products, as well as manufacturers of licensed devices and biological products used in device manufacturing. The regulation defines key terms including blood products, establishments, manufacturing processes, and commercial distribution, and applies to blood banks, plasma donor centers, transfusion services, and independent testing laboratories.