medical devices Archives - Page 5 of 258

Meeting Notice: February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of…

Mammography Record Retention: What Should I Keep, and For How Long?

The Mammography Quality Standards Act (MQSA) includes provisions related to record retention and transfer. Under MQSA, original mammograms and their reports are considered medical records. A facility must “maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 years, or not less than 10…

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150059 added)

La FDA advierte a los proveedores de atención médica que no deben basarse únicamente en los resultados de la prueba serológica de IgM frente al virus del Zika; les recuerda que esperen los resultados de la prueba de confirmación antes de decidir el tratamiento del paciente: Comunicación de Seguridad de la FDA

English Fecha de publicación: 22 de diciembre del 2016 De interés para: Proveedores de servicos de salud Mujeres embarazadas que pudieron ser expuestas al Zika Especialidades médicas: Atención medicina general, obstetricia y ginecología y enfermedades infecciosas Producto: La prueba de inmunoabsorción enzimática (ELISA, por sus siglas en inglés) del anticuerpo IgM de captura ZIKV Detect…

Class I Medical Device Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections

CDRH to Post Early Notification of Recalls

When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place. Correction – Addresses a problem with a medical device in the place where it is used or sold. Removal – Addresses a problem with a medical…

Premarket Notification (510(k)) Submissions for Bone Anchors

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Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types Guidance for Industry and Food and Drug Administration Staff

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Webinar – Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

On Thursday, February 9, 2017, the FDA will host a webinar to share information and answer questions about the final guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The purpose of this guidance is to clarify FDA’s approach to weighing benefits and risks for medical device…

Webinar – Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types

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