Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).     

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Ear, nose, and throat devices; classification of the nasal dilator, the intranasal splint, and the bone particle collector. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls). FDA is also exempting the devices from the requirements of premarket notification. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Postmarket surveillance. Final rule

The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.     

Removal of regulations regarding certification of antibiotic drugs--FDA. Direct final rule

The Food and Drug Administration (FDA) is repealing its regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.     

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

General and plastic surgery devices; classification of the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Administrative practices and procedures; internal agency review of decisions--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published in the Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to implement the new Dispute Resolution provision of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on August 31, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medical devices; humanitarian use of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing humanitarian use devices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations to include a list of drug products that may not be used for pharmacy compounding pursuant to the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Removal of regulations regarding certification of antibiotic drugs; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.     

Medical devices; establishment registration and device listing for manufacturers and distributors of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing establishment registration and device listing by domestic distributors. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

Orthopedic devices: classification and reclassification of pedicle screw spinal systems--FDA. Final rule

The Food and Drug Administration (FDA) is classifying certain previously unclassified preamendments pedicle screw spinal systems into class II (special controls) and reclassifying certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action because it believes that special controls would provide reasonable assurance of safety and effectiveness. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule

The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.