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; reclassification and codification of natural nonabsorbable silk surgical suture--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the reclassification and codification of natural nonabsorbable silk surgical suture. FDA issued an order in the form of a letter to the manufacturer reclassifying the device from class III (premarket approval) into class II (special controls). Accordingly, FDA is amending the regulations as set forth below.     

Medical devices: reclassification and codification of the absorbable polydioxanone surgical suture. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA," which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.     

Medical devices; reclassification and codification of microsurgical argon laser for rhinology and laryngology--FDA. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to HGM Medical Laser Systems, Inc., reclassifying the microsurgical argon laser for use in rhinology and laryngology from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations as specified herein.     

Medical devices; reclassification and codification of suction lipoplasty system for aesthetic body contouring--FDA. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to the American Society for Aesthetic Plastic Surgery (ASAPS) reclassifying the suction lipoplasty system for use in aesthetic body contouring from class III (premarket approval) to class II (special controls). The reclassification is based on information regarding the device contained in a reclassification petition submitted by ASAPS and other publicly available information. Accordingly, the order is being codified in the Code of Federal Regulations. This action is taken under the Medical Device Amendments of 1976 (the 1976 amendments) as amended by the Safe Medical Devices Act of 190 (the SMDA).     

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; reclassification and codification of absorbable poly(glycolide/L-lactide) surgical suture--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the reclassification and codification of the absorbable poly(glycolide/L-lactide) surgical suture (PGL suture). FDA issued an order in the form of a letter to the manufacturer reclassifying the PGL suture from class III into class II.     

Medical devices; reclassification and codification of hip joint metal polymer/metal semi-constrained porous-coated uncemented prosthesis--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the reclassification and codification of the hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. FDA issued an order in the form of a letter to two manufacturers reclassifying the device from class III into class II. Accordingly, FDA is amending the regulations as set forth below.     

Medical devices; reclassification and codification of the stainless steel suture. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Alto Development Corp. (the petitioner) reclassifying the 316L stainless steel suture for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations (CFR). Although FDA reclassified the device in 1986, it inadvertently neglected to publish a notice of the reclassification in the Federal Register or codify the change in the CFR.     

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will 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; classification/reclassification; restricted devices; analyte specific reagents--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify analyte specific reagents (ASR's) presenting a low risk to public health into class I (general controls), and to exempt these class I devices from the premarket notification (510(k)) requirements. FDA is classifying/reclassifying ASR's used in certain blood banking tests as class II (special controls) because general controls are insufficient to provide a reasonable assurance of safety and effectiveness. Finally, ASR's presenting a high risk are being classified or retained in class III (premarket approval). FDA is also designating all ASR's as restricted devices under the Federal Food, Drug and Cosmetic Act (the act), and establishing restrictions on their sale, distribution and use. The scope of products covered by this final rule includes both pre- 1976 devices, which have not been previously classified, as well as post- 1976 devices, which are statutorily classified into class III. The intent of this final rule is to regulate these pre- and post-1976 devices in a consistent fashion. This rulemaking does not affect requirements for reagents that are subject to licensure under the Public Health Service Act (the PHS Act). This rulemaking also does not affect reagents sold to nonclinical settings, including those reagents sold as components to manufacturers of cleared or approved in vitro diagnostic tests.     

Medical devices; reclassification and codification of the nonabsorbable expanded polytetrafluoroethylene surgical suture. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to W.L. Gore and Associates, Inc., reclassifying the nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture intended for use in soft tissue approximation and ligation, including cardiovascular surgery, from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations (CFR).     

Medical devices; classification/reclassification of immunohistochemistry reagents and kits--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify immunohistochemistry reagents and kits (IHC's) into three classes depending on intended use. FDA is classifying/reclassifying into class I (general controls) and exempt from premarket notification requirements IHC's used as adjunctive tests and presenting a low risk to public health. FDA is classifying/reclassifying into class II (special control) IHC's that detect or measure certain target analytes and that provide prognostic or predictive data that is not confirmed by routine histopathologic control specimens. The results of the class II IHC's are reported independently to the clinician, and the performance claims are widely accepted and supported by valid scientific evidence. FDA is classifying/reclassifying into class III (premarket approval) IHC's intended for any other use. The scope of products covered by this final rule includes both pre-1976 devices that have not been previously classified, as well as post-1976 devices that are statutorily classified into class III. The intent of this final rule is to regulate pre-1976 devices and post-1976 devices in a consistent fashion. Therefore, FDA is classifying or reclassifying these products as applicable.     

Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.     

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.     

Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. FDA is reclassifying these devices on its own initiative on the basis of new information. 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 Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. 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 these devices.     

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).     

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; device tracking. Final rule

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.     

Medical devices; ear, nose and throat devices; reclassification of the endolymphatic shunt tube with valve. Final rule

The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA" (the guidance) as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is based on new information submitted in are classification petition by E. Benson Hood Laboratories, Inc. (Hood Laboratories). 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 Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the guidance.