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At least 415 records · Page 23Linked to original sources
PubMed2001

Orthopedic devices: classification and reclassification of pedicle screw spinal systems; technical amendment. Final rule; technical amendment.

The Food and Drug Administration (FDA) is correcting a final rule that classified certain previously unclassified pre amendments pedicle screw spinal systems and reclassified certain post amendments pedicle screw spinal systems. The agency is correcting the rule to include an intended use that was inadvertently omitted from the codified language in the rule. In addition, the agency is correcting the rule to clarify that, when intended for certain uses, the device is a pre amendments, not a post amendments, device. 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 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Bone Screws↗
PubMed2002

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.

Bone Cements↗
PubMed1975

Nonpsychotic personality disturbances: a re-evaluation and reclassification.

The classical notion of neurosis as the prototypical form of nonpsychotic personality disturbance must be rejected in favor of the categories of (a) personality pattern disturbance and disorder of life style, and most especially, (b) character disorder. Category (a) would include schizoid, paranoid, and cyclothymic personality pattern disturbances and compulsive and hysteroid personality as disorders of life style. Each of these would occupy one end of a 'psychotoid' continuum, at the other end of which would be a familiar type of psychosis such as paranoid schizophrenia or pseudoneurotic schizophrenia. The most numerous of the nonpsychotic disturbances (in the tens of millions in the USA alone) come under category (b), the character disorders, involving a special sort of failure to inhibit impulse and unsocialized self-seeking. Character disorders are seen by us as turning on an eccentric axis, alternating between the two foci of 'dependency' and 'aggression'.

Aggression↗
PubMed2002

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.

Device Approval↗
PubMed2000

[Reclassification of Saccharomyces strains by comparative electrophoretic karyotyping].

The strains of Saccharomyces Meyen ex Reess preserved in China General Microbiological Culture Collection Center (CGMCC) were recharacterized and reidentified according to recent taxonomic improvement of the genus. The strains AS 2.100 (originally classified in S. cerevisiae), AS 2.1158(from former USSR and originally classified in S. exiguus) and AS 2.1555(from Australia and originally classified in S. uvarum) were found to be different from the standard descriptions of the species concerned in some physiological properties. Comparative CHEF electrophoretic karyotype analysis showed that the chromosomal DNA banding pattern of AS 2.100 was similar to that of the type strain of S. bayanus, while the electrophoretic karyotypes of AS 2.1158 and AS 2.1555 were similar to those of the type and authentic strains of S. cerevisiae. Therefore, AS 2.100 was reidentified as S. bayanus, and AS 2.1158 and AS 2.1555 were reclassified in the species S. cerevisiae.

Chromosome Banding↗
PubMed2001

[Study on reclassification of extremely thermoacidophilic archaea strain S5].

The further study on thermoacidophilic archaea strain S5, with has been identified as Sulfosphaerellus thermoacidophilum gen.nov.,sp.nov, has shown it was able to grow facultatively aerobically by means of two sulfur-metabolizing modes of chemolithotrophy which is the characteristic of Acidianus. And the 16SrRNA gene of strain S5 was amplified, cloned and sequenced, a phylogenetic tree was constructed on the 16SrRNA gene sequences. The tree clearly indicated that strain S5 formed the same lineage with Acidianus brierleyi. Thus strain S5 should be the member of Acidianus. However, there are only 44%, 22% and 23% genomic DNA similarity between S5 and A. brierleyi. A. infernus and A. ambivalens, respectively. And the G + C content of S5 DNA is 38%, which is 5% ~ 7% higher than the reported G + C contents of the other Acidianus species (31% or 32.7%) . In addition, strain S5 is a strictly chemolithoautotrophs, which is obviously different from facultative chemolithotrophs of A brierleyi. Based on the observed differences, strain S5 represents a new species within the genus Acidianus. A new species name, Acidianus tengchongenses, was proposed for it. The type strain is designated S5.

Acidianus↗
PubMed2003

Medical Devices; hematology and pathology devices; reclassification of automated blood cell separator device operating by filtration principle from class III to class II. Final rule.

The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse reactions to be filed by the manufacturer for a minimum of 3 years. 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 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is reclassifying the automated blood cell separator devices operating by filtration principle into class II (special controls) because special controls, in addition to general controls, are capable of providing a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed2003

Medical devices; reclassification of the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and the knee joint femorotibial (unicompartmental) metal/polymer porous-coated uncemented prosthesis. Final rule.

The Food and Drug Administration (FDA) is announcing that it has reclassified two fixed-bearing knee joint prostheses, the knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace a knee joint, and the knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis, which is intended to be implanted to replace part of a knee joint. FDA has reclassified the devices from class III (premarket approval) into class II (special controls). The special control that will apply is a guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The agency is reclassifying these devices into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the devices, and there is sufficient information to establish 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 devices.

Device Approval↗
PubMed2003

[Postpartum reclassification in women with gestational diabetes and analyzing the high risk factors associated with them].

OBJECTIVE: To follow up the 75 g oral glucose tolerance test (OGTT) in gestational diabetes mellitus (GDM) at 2 month after birth for reclassifying and analyzing the risk factors associated with the abnormal blood glucose level. METHODS: 294 cases of GDM underwent a 2 hours 75 g OGTT two months postpartum. According to the WHO diagnostic criteria, they were divided into three groups: (1) type 2 diabetic mellitus (DM), impaired glucose tolerance (IGT) and normal. The related factors during pregnancy were analysed. RESULTS: 160 cases (54.4%) were normal, 75 cases (25.5%) and 59 cases (20.1%) were IGT and DM respectively. (2) In the DM group, the gestational age at diagnosis was much earlier than those of the other two groups (P < 0.01), the glucose level of 50 gram glucose challenge test (GCT) and fasting blood glucose values in OGTT and the value of HbAlc at diagnosis were evidently higher than the other two groups (P < 0.01, P < 0.01, P < 0.01), the gestational age of use of insulin for treatment was earlier than normal group, the dosage used markedly greater than the other two groups, the fasting blood glucose and 2 hours postprandial glucose were significantly higher than other two groups (P < 0.01) within 7 days after birth. Maternal age, body weight and family history did not show difference in the three groups. CONCLUSION: Among the GDM, about 1/4 were IGT and 1/5 were type 2 DM. The DM group showed early diagnosis, high fasting blood glucose, high frequency to use insulin during pregnancy.

Adult↗