Medical devices; reclassification of three anesthesiology preamendments class III devices into class II. Final rule.
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The Food and Drug Administration (FDA) is reclassifying three anesthesiology preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997. (+info)
Medical devices; exemptions from premarket notification; class II devices. Final rule.
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The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). (+info)
Female condom reuse in Lusaka, Zambia: evidence from 12 cases.
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Female condom reuse could address one of the principal barriers to use, namely, cost; however, the safety of reuse has not been established. Recent reports have provided information related to reuse safety under carefully specified research study conditions. Still, little is known about reuse outside a research study context, and there are outstanding questions related to feasibility of reuse among general populations. This study reports on naturally occurring reuse from a small, purposive sample of self-identified women who, prior to the study, had reused the female condom of their own volition without reuse instruction. Three types of reuse were identified. Most women attempted to clean devices between removal and reinsertion. A number of agents, including water (only), bath soap, laundry detergent, Dettol, and beer were used for cleaning. A number of agents were used for relubrication, including Reality((R)) lubricant, various kinds of cooking oil, and Vaseline((TM)). Perception of the strength and integrity of female condoms making them suitable for reuse were influenced by both provider advice and product packaging. Most participants reported no problems with reuse. Some women, faced with barriers to single use of a female condom or use of an acceptable alternative, will resort to reuse and rely on their own "common sense" notions to implement reuse. Providers and purveyors have opportunities to shape responses to reuse for the better, and the research community is obligated to provide a solid scientific base regarding reuse safety. (+info)
The acceptability of reuse of the female condom among urban South African women.
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This study assessed whether reuse of the female condom was acceptable among two groups of women in central Johannesburg, South Africa, who were taking part in two separate studies of female condom reuse. The first group consisted of women (aged 17 to 43 years) attending a family planning/sexually transmitted infections (STIs) clinic who were participating in a cross-sectional survey of the acceptability of female condoms reuse (n = 100). The second group included women (aged 18-40 years) at high risk for STI (80% self-declared sex workers) who were taking part in an ongoing cohort study to investigate the safety of reuse of the female condom through a structural integrity and microbial retention study (n = 50). Among women participating in the acceptability study, 83% said that they would be willing to reuse the female condom, and 91% thought the idea of reuse of the female condom was acceptable. All women taking part in the safety of reuse study and who reused the female condom up to seven times (n = 49) reported that the steps involved in reusing the device were easy to perform and acceptable. All 49 women said they would reuse the female condom at least once, while 45% said they would use it a maximum of seven or eight times. From the results of the interviews with both study groups, it can be concluded that, among women in a South African urban environment who have used a male and/or female condom, the concept of reuse of the female condom is acceptable and thought to be a good idea. (+info)
Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.
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The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997. (+info)
Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule.
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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. (+info)
A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study.
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OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months. (+info)
Medical devices; device tracking. Final rule.
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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. (+info)