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https://www.readbyqxmd.com/read/30382695/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-meprobamate-test-system-final-order
#1
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the meprobamate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the meprobamate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
November 1, 2018: Federal Register
https://www.readbyqxmd.com/read/30382694/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-insulin-therapy-adjustment-device-final-order
#2
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens...
November 1, 2018: Federal Register
https://www.readbyqxmd.com/read/30375807/schedule-for-rating-disabilities-the-hematologic-and-lymphatic-systems-final-rule
#3
(no author information available yet)
This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities (VASRD) by revising the section of the Rating Schedule that addresses the hematologic and lymphatic systems. This action will ensure VA uses current medical terminology and provides detailed and updated criteria for evaluating conditions pertaining to the hematologic and lymphatic systems.
October 29, 2018: Federal Register
https://www.readbyqxmd.com/read/30362696/medical-devices-ear-nose-and-throat-devices-classification-of-the-active-implantable-bone-conduction-hearing-system-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 26, 2018: Federal Register
https://www.readbyqxmd.com/read/30362695/medical-devices-anesthesiology-devices-classification-of-the-high-flow-humidified-oxygen-delivery-device-final-order
#5
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the high flow humidified oxygen delivery device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high flow humidified oxygen delivery device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 26, 2018: Federal Register
https://www.readbyqxmd.com/read/30358958/presumption-of-herbicide-exposure-and-presumption-of-disability-during-service-for-reservists-presumed-exposed-to-herbicides-final-rule
#6
(no author information available yet)
The Department of Veterans Affairs (VA) is adopting as final an interim final rule published on June 19, 2015, to amend its adjudication regulation governing individuals presumed to have been exposed to certain herbicides. Specifically, VA expanded the regulation to include an additional group consisting of individuals who performed service in the Air Force or Air Force Reserve under circumstances in which they had regular and repeated contact with C-123 aircraft known to have been used to spray an herbicide agent ("Agent Orange") during the Vietnam era...
October 22, 2018: Federal Register
https://www.readbyqxmd.com/read/30358957/medical-devices-ophthalmic-devices-classification-of-the-intranasal-electrostimulation-device-for-dry-eye-symptoms-final-order
#7
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358956/medical-devices-neurological-devices-classification-of-the-thermal-vestibular-stimulator-for-headache-final-order
#8
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the thermal vestibular stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358955/medical-devices-general-and-plastic-surgery-devices-classification-of-the-hemostatic-device-for-intraluminal-gastrointestinal-use-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemostatic device for intraluminal gastrointestinal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358954/medical-devices-general-and-plastic-surgery-devices-classification-of-the-light-based-energy-source-device-for-topical-application-final-order
#10
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358383/medical-devices-general-and-plastic-surgery-devices-classification-of-the-wound-autofluorescence-imaging-device-final-order
#11
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358382/medical-devices-anesthesiology-devices-classification-of-the-positive-airway-pressure-delivery-system-final-order
#12
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the positive airway pressure delivery system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 19, 2018: Federal Register
https://www.readbyqxmd.com/read/30358381/medical-devices-neurological-devices-classification-of-the-external-upper-limb-tremor-stimulator-final-order
#13
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external upper limb tremor stimulator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 17, 2018: Federal Register
https://www.readbyqxmd.com/read/30358377/medical-devices-immunology-and-microbiology-devices-classification-of-the-herpes-virus-nucleic-acid-based-cutaneous-and-mucocutaneous-lesion-panel-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 17, 2018: Federal Register
https://www.readbyqxmd.com/read/30272400/schedules-of-controlled-substances-placement-in-schedule-v-of-certain-fda-approved-drugs-containing-cannabidiol-corresponding-change-to-permit-requirements-final-order
#15
(no author information available yet)
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961...
September 28, 2018: Federal Register
https://www.readbyqxmd.com/read/30272398/obstetrical-and-gynecological-devices-reclassification-of-single-use-female-condom-to-be-renamed-single-use-internal-condom-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information...
September 27, 2018: Federal Register
https://www.readbyqxmd.com/read/30265475/definition-of-domiciliary-care-final-rule
#17
(no author information available yet)
The Department of Veterans Affairs (VA) adopts as final, with no changes, a proposed rule amending the definition of domiciliary care to encompass VA's Mental Health Residential Rehabilitation Treatment Program (MH RRTP). This rule aligns regulations with VA's administrative decision in 2005 to designate MH RRTP as a type of domiciliary care. We also proposed clarifying that domiciliary care provides temporary, not permanent, residence to affected veterans. We provided a 60-day comment period on this proposed rule and received 4 comments, all of which were generally supportive of the proposed changes...
September 25, 2018: Federal Register
https://www.readbyqxmd.com/read/30226348/net-worth-asset-transfers-and-income-exclusions-for-needs-based-benefits-final-rule
#18
(no author information available yet)
The Department of Veterans Affairs (VA) amends its regulations governing veterans' eligibility for VA pensions and other needs-based benefit programs. The amended regulations establish new requirements for evaluating net worth and asset transfers for pensions and identify which medical expenses may be deducted from countable income for VA's needs-based benefit programs. The amendments help to ensure the integrity of VA's needs-based benefit programs and the consistent adjudication of pension and parents' dependency and indemnity compensation claims...
September 18, 2018: Federal Register
https://www.readbyqxmd.com/read/30199077/findings-of-research-misconduct
#19
(no author information available yet)
No abstract text is available yet for this article.
August 31, 2018: Federal Register
https://www.readbyqxmd.com/read/30198687/schedules-of-controlled-substances-temporary-placement-of-n-ethylpentylone-in-schedule-i-temporary-amendment-temporary-scheduling-order
#20
(no author information available yet)
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic cathinone, 1- (1,3-benzodioxol-5-yl)-2-(ethylamino)- pentan-1-one (N-ethylpentylone, ephylone) and its optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of Nethylpentylone in schedule I of the Controlled Substances Act (CSA) is necessary to avoid an imminent hazard to the public safety...
August 31, 2018: Federal Register
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