Medical devices; general and plastic surgery devices; classification of absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. Final rule

The Food and Drug Administration (FDA) is classifying the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid (DNA) technology into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology." The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

Medical devices; radiology devices; reclassification of bone sonometers. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers" that will serve as the special control for these devices.     

Medical devices; general hospital and personal use devices; classification of remote medication management system. Final rule

The Food and Drug Administration (FDA) is classifying the remote medication management systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System," which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Medical devices; immunology and microbiology devices; classification of ovarian adnexal mass assessment score test system. Final rule

The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices     

Medical devices; obstetrical and gynecological devices; classification of computerized labor monitoring system. Final rule

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Microbiology devices; reclassification of hepatitis A virus serological assays. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays" that will serve as the class II special control for these devices.     

Medical devices; reclassification of the cutaneous carbon dioxide and the cutaneous oxygen monitor. Final rule

The Food and Drug Administration (FDA) is reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA is also reclassifying the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II [[Page 76679]] Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA" that will serve as the special control for the devices. These reclassifications are taken on the agency's own initiative based on new information. These actions are 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), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. 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 (the FDAMA).     

Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." 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 (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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device.     

Medical devices; clinical chemistry and clinical toxicology devices; drug metabolizing enzyme genotyping system. Final rule

The Food and Drug Administration (FDA) is classifying drug metabolizing enzyme (DME) genotyping test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications." Elsewhere in this issue of the Federal Register. FDA is announcing the availability of this guidance document. 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 these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.     

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.     

Medical devices: immunology and microbiology devices: classification of in vitro human immunodeficiency virus drug resistance genotype assay. Final rule

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay." FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

Medical devices; ear, nose, and throat devices; classification of olfactory test device. Final rule

The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.     

Medical devices; immunology and microbiology devices; classification of the beta-glucan serological assay. Final rule

The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan." 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 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Clinical chemistry and clinical toxicology devices; classification of B-type natriuretic peptide test system. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the B-type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers." 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 these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the device.     

Medical devices; cardiovascular devices; classification of implantable intra-aneurysm pressure measurement system. Final rule

The Food and Drug Administration (FDA) is classifying the implantable intra-aneurysm pressure measurement system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.     

Medical devices; immunology and microbiology devices; classification of Plasmodium species antigen detection assays. Final rule

The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.     

Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction laser system. Final rule

The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.