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With the aggressive stance taken by the IRS regarding worker classification, many organizations may be risking significant retroactive assessments with respect to the use of independent contractors. Employers should be aware of the 20 primary factors considered by the IRS when examining independent contractor relationships and prepare in advance for IRS classification review or audit.
The Food and Drug Administration (FDA) is proposing to reclassify over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls), and to exempt them from the premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also proposing to designate OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act), and to establish restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is proposing a conforming amendment to the existing classification regulation for specimen transport and storage containers, to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
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).
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to INCSTAR Corp. reclassifying INCSTAR 25-Hydroxyvitamin D 125I Radioimmunoassay (RIA). This radioimmunoassay device is intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. The device and substantially equivalent devices of this generic type were reclassified from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations.
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Although "giant cell tumor of soft parts" has traditionally been considered a single entity as reflected in the original term "malignant giant cell tumor of soft parts (MGCT)" and later by the term "malignant fibrous histiocytoma, giant cell type" the degree of atypia and mitotic activity varies in this group, suggesting biologic heterogeneity. The clinicopathologic features of 31 tumors meeting the traditional criteria of MGCT but having only mild to moderate nuclear atypia are presented. Patients with these tumors (19 females; 12 males) ranged in age from 14 to 84 years (mean, 40 years) and presented with masses of involving either superficial (n = 16) or deep (n = 13) soft tissue. Most occurred on the arm or hand (n = 16) and ranged in size from 0.7 to 6.5 cm (mean, 2.1 cm). The tumors consisted of sheets and nodules of rounded mononuclear cells that blended with spindled cells and benign osteoclastic giant cells. Pleomorphic giant cells were absent. Osteoid was noted in 10 cases, but features typically associated with tenosynovial giant cell tumors (such as dense stromal hyaline, siderophages, and xanthoma cells) were nearly always absent. Mitotic figures ranged from 1-10/10 HPF (mean, 2-3/10 high-powered field), and angiolymphatic invasion was present in 10 cases. Necrosis was absent, however. The mononuclear cells expressed CD68, tartrate-resistant acid phosphatase, and smooth muscle actin, but lacked CD45, S100 protein, desmin, and lysozyme, an immunophenotypic profile identical to that of giant cell tumor of bone. Follow-up information in 19 patients (mean, 3 yrs; median, 1-7 yrs) indicated recurrences in four patients, but none developed metastasis. This behavior contrasts significantly with the high-grade behavior traditionally associated with MGCT of soft parts. These giant cell tumors can be consistently recognized by the lack of cytologic atypia even in the face of mitotic activity and vascular invasion. Although their long term metastatic risk is not fully defined, we propose they be termed "giant cell tumors of low malignant potential" and regarded as the soft tissue analogue of giant cell tumor of bone. The term "malignant giant cell tumor of soft parts" or giant cell malignant fibrous histiocytoma should be restricted to histologically high-grade lesions.
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This paper reports on the experiences from evaluation of GALEN methods for mapping of follow-up categories in the domain of thoracic surgery to an existing classification of surgical procedures. The mapping of the aggregated levels or groups of thoracic procedures presents a genuine problem in relation to strict hierarchical classifications, since the follow-up categories not necessarily fit in the pre-set structure of the classification. The paper reports on the experiences from modelling of the traditional classification as well as modelling of the follow-up categories, together with an analysis of results with a discussion of opportunities and potential problems and pitfalls when applying GALEN models and tools.
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OBJECTIVE: To retrospectively review a series of 12 patients operated on in our department for stromal tumor of the stomach. Clinical and morphological data, and the patients' postoperative course, were analyzed. METHODS: Medical records for 12 patients (mean age 63.3 years) were retrospectively reviewed to obtain data on clinical presentation, diagnosis and treatment. Surgical morbidity and mortality were analyzed. A pathologist reviewed the resected specimens to determine the morphological factors of prognostic value. The biological nature of the tumor was reclassified based exclusively on mitotic index, and all tumors were staged according to the TGM system. Recurrence and survival rates were also calculated. RESULTS: The most frequent clinical presentation was abdominal pain and gastrointestinal bleeding. The most sensitive diagnostic methods were computerized tomography and echographic endoscopy. Operability and resectability rates were 100% and 91.6% respectively. Local resection was done in 5 patients, partial gastrectomy in 5, and extended total gastrectomy in 1. Histologically, 6 cases were muscular tumors (2 leiomyomas, 3 low-grade leiomyosarcomas and 1 high-grade leiomyosarcoma), 2 were gastrointestinal autonomic nerve (GAN) tumors, and 4 were pure stomal tumors. The morbidity rate was 33.3% and the mortality rate was 8.3% (1 patient). All patients were followed up: 1 patient each died after 9 months and 4 years, 1 developed liver metastases after a disease-free interval of 14 months, and the other 9 patients were still alive and free of disease after intervals ranging from 4 months to 7 years. CONCLUSIONS: Stromal tumors include a group of tumors which may present muscular differentiation (the most frequent type), neural differentiation (GAN tumors) or no differentiation at all (pure stromal tumors). The mitotic index is the most valid parameter to determine biological nature, considering that classification as a benign tumor requires the total absence of mitoses. Treatment was mostly surgical, and local resection with adequate safety margins was effective. Prognosis was relatively good, but long-term follow-up is needed to assess the malignant potential of these tumors.
Macroscopic intrahepatic portosystemic venous shunts (IHPSS) are defined as communications between the portal and the systemic venous circulation, measuring more than 1mm in diameter, and at least partially located inside the liver. Four different types can be identified based on anatomical, clinical, and pathophysiological criteria. Type I includes patent paraumbilical veins, located in the liver, and commonly encountered in portal hypertension. Types II, III, and IV are much less common and have been reported in only 47 publications in the entire French and English literature. They include shunts, unique or multiple, between a portal branch and a hepatic vein, located either in two adjacent liver segments (type II) or in non-adjacent liver segments (type III). Type IV corresponds to any tubular communication developed between the right portal branch and the inferior vena cava. The exceptional patent ductus venosus or a patent umbilical vein should not be considered as IHPSS since their course is strictly extrahepatic.
The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.
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).
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Intelligent Surgical Lasers, Inc. (ISL), (now doing business as Escalon Medical Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for use in peripheral iridotomy from class III to class II (special controls). Accordingly, the order is now being codified in the Code of Federal Regulations (CFR) as described below.
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.
The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness.