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).     

Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

General and plastic surgery devices; effective date of requirement for premarket approval of the silicone inflatable breast prosthesis. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the silicone inflatable breast prosthesis, a generic type of medical device intended to augment or reconstruct the female breast. This device is made of a silicone shell that is inflated with sterile isotonic saline. Commercial distribution of this device must cease unless a manufacturer or importer has filed with FDA a PMA or PDP for its version of the silicone inflatable breast prosthesis within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. 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 amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

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).     

General hospital and personal use devices; classification of the Apgar timer, lice removal kit, and infusion stand--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to classify the Apgar timer, lice removal kit, and infusion stand into class I. FDA is also publishing the recommendations of the General Hospital and Personal Use Devices Panel (the panel) regarding the classification of the devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying the devices. 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 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Gastroenterology-urology devices: reclassification of the penile rigidity implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. 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 Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.     

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; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. 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). FDA is taking this action in order to implement a requirement of FDAMA.     

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic 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.     

Effective date of requirement for premarket approval for three class III preamendments devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.     

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).     

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. 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 FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.     

Dental devices; classification for intraoral devices for snoring and/or obstructive sleep apnea. Final rule

The Food and Drug Administration (FDA) is classifying the intraoral devices for snoring and/or obstructive sleep apnea into class II (special controls). These devices are used to control or treat simple snoring and/or obstructive sleep apnea. This classification is based on the recommendations of the Dental Devices Panel (the Panel), and is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. 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). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that will serve as the special control for this final rule.     

Dental devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule

The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls 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.     

Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. 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 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.     

Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule

The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C 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). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,' which will serve as the special control for this device.     

Medical devices; reclassification of tumor-associated antigen immunological test system--FDA. Final rule

The Food and Drug Administration (FDA) is announcing that it is codifying the reclassification of tumor-associated antigen immunological test systems intended as an aid in monitoring patients for disease progression or response to therapy or for the detection of recurrent or residual disease from class III (premarket approval) to class II (special controls). FDA is also announcing that it has issued an order in the form of a letter to Centocar, Inc., reclassifying serum tumor markers into class II. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.     

Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule

The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. 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. FDA is taking this action 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 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).     

General and plastic surgery devices; classification of silicone sheeting. Final rule

The Food and Drug Administration (FDA) is classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (general controls). As a class I device, the device will be exempt from premarket notification requirements. This action is 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 Devices User Fee Modernization Act of 2002 (MDUFMA).