RESUMEN
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Terapia Electroconvulsiva/clasificación , United States Food and Drug Administration/legislación & jurisprudencia , Terapia Electroconvulsiva/instrumentación , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Asunto(s)
Equipo Dental/clasificación , Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Dentaduras , Falla de Equipo , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds' 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.
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Tratamiento con Ondas de Choque Extracorpóreas/clasificación , Tratamiento con Ondas de Choque Extracorpóreas/instrumentación , Enfermedad Crónica , Humanos , Estados Unidos , Heridas y Lesiones/terapiaRESUMEN
The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Dispositivos de Protección Respiratoria/clasificación , Seguridad de Equipos/clasificación , Humanos , Máscaras/clasificación , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device, a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. 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. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. This order reclassifies these types of devices from class III to class II and will reduce regulatory burdens on industry because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Asunto(s)
Equipos y Suministros de Hospitales/clasificación , Eliminación de Residuos Sanitarios/instrumentación , Seguridad de Equipos/clasificación , Humanos , Agujas , Estados UnidosRESUMEN
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Asunto(s)
Tipificación y Pruebas Cruzadas Sanguíneas/clasificación , Tipificación y Pruebas Cruzadas Sanguíneas/instrumentación , Computadores/clasificación , Programas Informáticos/clasificación , Bancos de Sangre , Donantes de Sangre , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Equipos y Suministros/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the microneedling device for aesthetic 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 microneedling device for aesthetic 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. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Asunto(s)
Agujas/clasificación , Cirugía Plástica/clasificación , Cirugía Plástica/instrumentación , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the in vivo cured intramedullary fixation rod 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 in vivo cured intramedullary fixation rod'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.
Asunto(s)
Fijación Intramedular de Fracturas/clasificación , Fijación Intramedular de Fracturas/instrumentación , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test 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 brain trauma assessment test'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.
Asunto(s)
Biomarcadores/sangre , Lesiones Encefálicas/diagnóstico , Juego de Reactivos para Diagnóstico/clasificación , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting 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 endoscopic electrosurgical clip cutting 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.
Asunto(s)
Electrocirugia/clasificación , Electrocirugia/instrumentación , Endoscopía del Sistema Digestivo/clasificación , Endoscopía del Sistema Digestivo/instrumentación , Seguridad de Equipos/clasificación , Humanos , Instrumentos Quirúrgicos/clasificación , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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.
Asunto(s)
Prostatectomía/clasificación , Prostatectomía/instrumentación , Seguridad de Equipos/clasificación , Humanos , Masculino , Estados Unidos , AguaRESUMEN
The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test 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 next generation sequencing based tumor profiling test'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.
Asunto(s)
Análisis de Secuencia de ADN/clasificación , Análisis de Secuencia de ADN/instrumentación , ADN de Neoplasias/genética , Seguridad de Equipos/clasificación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders 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 percutaneous nerve stimulator for substance use disorders' 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.
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Estimulación Eléctrica Transcutánea del Nervio/clasificación , Estimulación Eléctrica Transcutánea del Nervio/instrumentación , Humanos , Trastornos Relacionados con Sustancias/terapia , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal 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 non-absorbable, hemostatic gauze for temporary internal 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. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Asunto(s)
Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Hemostáticos/clasificación , Apósitos Oclusivos/clasificación , Equipo Quirúrgico/clasificación , Hemostasis , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems 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 Lynch syndrome test systems' 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.
Asunto(s)
Neoplasias Colorrectales Hereditarias sin Poliposis/sangre , Aprobación de Recursos/legislación & jurisprudencia , Seguridad de Equipos/clasificación , Inmunohistoquímica/clasificación , Inmunohistoquímica/instrumentación , Reparación de la Incompatibilidad de ADN , Humanos , Juego de Reactivos para Diagnóstico/clasificación , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures 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 temporary catheter for embolic protection during transcatheter intracardiac procedures' 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.
Asunto(s)
Catéteres Cardíacos/clasificación , Dispositivos de Protección Embólica/clasificación , Seguridad de Equipos/clasificación , Procedimientos Quirúrgicos Cardíacos/clasificación , Procedimientos Quirúrgicos Cardíacos/instrumentación , Humanos , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator'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.
Asunto(s)
Filtros de Aire/clasificación , Seguridad de Equipos/clasificación , Humo , Electrocirugia , Humanos , Laparoscopía/instrumentación , Estados UnidosRESUMEN
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor 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 irrigating wound retractor 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.
Asunto(s)
Seguridad de Equipos/clasificación , Instrumentos Quirúrgicos/clasificación , Irrigación Terapéutica/clasificación , Irrigación Terapéutica/instrumentación , Humanos , Cirugía Plástica/clasificación , Cirugía Plástica/instrumentaciónRESUMEN
The Food and Drug Administration (FDA or we) is classifying the whole slide imaging 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 whole slide imaging 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.