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At least 163 records · Page 9Linked to original sources
PubMed1993

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.

Argon↗
PubMed1993

Independent contractors or employees? Reducing reclassification risks.

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.

Contract Services↗
PubMed1998

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing--FDA. Proposed rule.

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.

Consumer Product Safety↗
PubMed1998

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).

Device Approval↗
PubMed1998

Medical devices; reclassification and codification of vitamin D test system--FDA. Final rule.

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.

Device Approval↗
PubMed1999

Soft tissue giant cell tumor of low malignant potential: a proposal for the reclassification of malignant giant cell tumor of soft parts.

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.

Acid Phosphatase↗