December 29, 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 102 of 102
Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
The Food and Drug Administration (FDA or we) is classifying the cerebrospinal fluid shunt 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 cerebrospinal fluid shunt 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.
Airworthiness Directives; General Electric Company Turbofan Engines
The FAA proposes to supersede Airworthiness Directive (AD) 2019-22-05, which applies to all General Electric Company (GE) CF34-8C model turbofan engines. AD 2019-22-05 requires initial and repetitive inspections of the operability bleed valve (OBV) fuel tubes, OBV bleed air manifold link rod assemblies, and the OBV fuel fittings. AD 2019- 22-05 also requires replacement of OBVs or related OBV hardware that fail inspection. Since the FAA issued AD 2019-22-05, the manufacturer has redesigned the OBV, which terminates the need for the repetitive inspections. This proposed AD would require initial and repetitive inspections of the OBV fuel tubes, OBV bleed air manifold link rod assemblies, and the OBV fuel fittings. This proposed AD would also require replacement of OBVs or related OBV hardware that fail inspection. As a terminating action to the repetitive inspections, this proposed AD would require replacement of certain OBVs installed on GE CF34-8C and CF34-8E model turbofan engines. The FAA is proposing this AD to address the unsafe condition on these products.
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