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Preview: Food and Drug Adminstration (FDA): CDRHNew

Food and Drug Adminstration (FDA): CDRHNew



Items added to the FDA's Center for Devices and Radiological Health website within the last month.



Last Build Date: Sat, 21 Jan 2017 02:46:17 GMT

 



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)

Thu, 19 Jan 2017 05:00:00 GMT

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concer...



Federal Register: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers; Draft Guidance for Industry and Review Staff; Availability

Thu, 19 Jan 2017 05:00:00 GMT

The FDA is announcing the availability of the draft guidance ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This draft guidance provides answers to common questions regard...



Federal Register: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period

Thu, 19 Jan 2017 05:00:00 GMT

The FDA is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR 60299) concerning our comprehensive review of our regulations and policies governing manufacturer communicatio...



Federal Register: Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling--Questions and Answers; Draft Guidance for Industry; Availability

Thu, 19 Jan 2017 05:00:00 GMT

The FDA is announcing the availability of the draft guidance ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' This draft guidance provides information for manufacturers, packers, and distribu...



Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers

Wed, 18 Jan 2017 05:00:00 GMT

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022, DEN160005, DEN150056 added)

Wed, 18 Jan 2017 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022, DEN160005, DEN150056 added)



Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers

Wed, 18 Jan 2017 05:00:00 GMT

Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers



Check the CDRH Customer Satisfaction Results

Tue, 17 Jan 2017 05:00:00 GMT

This page provides real time results for CDRH's customer satisfaction survey.



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN160001 DEN100013 added)

Tue, 17 Jan 2017 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN160001 DEN100013 added)



UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication

Tue, 17 Jan 2017 05:00:00 GMT

In February 2016, PENTAX issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the...



Federal Register: Cardiovascular Devices; CFR Correction

Fri, 13 Jan 2017 05:00:00 GMT

In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2016, on page 371, Sec. 870.5800 is reinstated to read as follows: Sec. 870.5800 Compressible limb sleeve. (a) Identification. A compressible limb sleeve ...



Emergency Use Authorization Amendment: Letter Granting EUA Amendment(s) for the Trioplex Real-time RT-PCR (CDC)

Fri, 13 Jan 2017 05:00:00 GMT

Emergency Use Authorization Amendment: Letter Granting EUA Amendment(s) for the Trioplex Real-time RT-PCR (CDC)



Federal Register: Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability

Fri, 13 Jan 2017 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.'' The purpose of this guidance is to provide greater clarity for FDA staff and In...



FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication

Fri, 13 Jan 2017 05:00:00 GMT

Fuji informed the Agency of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. On January 13, 2017, Fuji notified its customers by issuing a Customer Notification Letter that...



Laboratory Developed Tests

Fri, 13 Jan 2017 05:00:00 GMT

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical...



Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

Thu, 12 Jan 2017 05:00:00 GMT

The purpose of this guidance is to provide greater clarity for FDA staff and investigational device exemption (IDE) sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE...



Federal Register: Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting

Thu, 12 Jan 2017 05:00:00 GMT

The FDA announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee. The general function of the committee is to provide advice and re...



Meeting Notice: March 17, 2017 Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee

Thu, 12 Jan 2017 05:00:00 GMT

Meeting Notice: March 17, 2017 Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee



Federal Register: Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens

Thu, 12 Jan 2017 05:00:00 GMT

The FDA is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into clas...



Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017

Thu, 12 Jan 2017 05:00:00 GMT

The FDA published a final guidance clarifying key factors it considers when assessing the benefits and risks of Investigational Device Exemption (IDE) submissions for human clinical study...



Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication

Wed, 11 Jan 2017 05:00:00 GMT

The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under..



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150059, DEN160003, and DEN160020 added)

Tue, 10 Jan 2017 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160003 added)



Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

Mon, 09 Jan 2017 05:00:00 GMT

The FDA is announcing the issuance of an Emergency Use Authorization for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, a...



Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Mon, 09 Jan 2017 05:00:00 GMT

The FDA announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's r...



Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication

Mon, 09 Jan 2017 05:00:00 GMT

The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone...



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

Mon, 09 Jan 2017 05:00:00 GMT

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



Federal Register: Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems, Correction

Mon, 09 Jan 2017 05:00:00 GMT

In document 2016-31670 beginning on page 96366 in the issue of 12/30/16, make the following correction: On page 96372, in the 2nd column, in the 25th, 51st, and 67th lines, and in the 3rd column, in 10th line, ``June 28, 2018'' should read ``July 1, 2019'



Federal Register: Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh

Fri, 06 Jan 2017 05:00:00 GMT

The FDA is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as...



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

Thu, 05 Jan 2017 05:00:00 GMT

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...



Federal Register: Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, Renewal

Wed, 04 Jan 2017 05:00:00 GMT

The FDA is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee by the Commissioner of Food and Drugs. The Commissioner has determined that it is in the public interest to renew the Technical Electronic Produ...



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

Wed, 04 Jan 2017 05:00:00 GMT

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

Wed, 04 Jan 2017 05:00:00 GMT

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) está alertando a médicos que atienden a mujeres embarazadas que reúnen los criterios clínicos y/o epidemiológicos de los CDC sobre el virus del Zika, que el laboratorio...



CDRH to Post Early Notification of Recalls

Tue, 03 Jan 2017 05:00:00 GMT

Beginning January 3, 2017 we will post information in the searchable Medical Device Recalls Database much earlier than we have done previously – at the time a firm takes a correction or removal action and notifies us that we can post it, rather than at...



MQSA National Statistics

Tue, 03 Jan 2017 05:00:00 GMT

In this section of MQSA Insights, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.



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

Tue, 03 Jan 2017 05:00:00 GMT

Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.



Federal Register: Premarket Notification (510(k)) Submissions for Bone Anchors; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Tue, 03 Jan 2017 05:00:00 GMT

The FDA is announcing the availability of the draft guidance entitled "Premarket Notification (510(k)) Submissions for Bone Anchors." The guidance provides recommendations for the information and testing that should be included in premarket submissions...



Federal Register: Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability

Fri, 30 Dec 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Medical Device Accessories--Describing Accessories and Classification Pathways for New Accessory Types.'' This document provides guidance to industry and FDA staff about the regulation of accesso...



Federal Register: Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems

Fri, 30 Dec 2016 05:00:00 GMT

The FDA is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device ``thoracolumbosacral pedicle screw systems''; reclassify dy...



Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff

Fri, 30 Dec 2016 05:00:00 GMT

This draft guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This guidance is issued for comment purposes only.



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

Thu, 29 Dec 2016 05:00:00 GMT

This guidance is intended to describe FDA’s policy concerning the classification of accessories and to discuss the application of that policy to devices that are commonly used as accessories to other medical devices. In addition, this guidance explains...



Webinar - Final Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - February 9, 2017

Thu, 29 Dec 2016 05:00:00 GMT

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...



Webinar - Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types - February 2, 2017

Thu, 29 Dec 2016 05:00:00 GMT

On Thursday, February 2, 2017, the FDA will host a webinar to share information and answer questions about the final guidance document, “Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types.” The purpose...



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160005 added)

Wed, 28 Dec 2016 05:00:00 GMT

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not...



Federal Register: Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability

Wed, 28 Dec 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Postmarket Management of Cybersecurity in Medical Devices.'' FDA is issuing this guidance to inform industry and FDA staff of the Agency's recommendations for managing postmarket cybersecurity vu...



Federal Register: Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments

Tue, 27 Dec 2016 05:00:00 GMT

The FDA is announcing the following public workshop entitled ``Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).'' The purpose of the public workshop is to obtain stakeholders' input on the coordination...



Federal Register: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; Availability

Tue, 27 Dec 2016 05:00:00 GMT

The FDA is announcing the availability of the guidance ``Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability Compliance, and Enforcement Decisions.'' This guidance is intended to provide clarity for FDA staff and industry ...



FDA Voice blog: Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology

Tue, 27 Dec 2016 05:00:00 GMT

Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has...



Health Industry Business Communications Council (HIBCC) Issuing Agency Accreditation Extension Letter

Tue, 27 Dec 2016 05:00:00 GMT

An FDA-accredited issuing agency (IA) is an organization that operates a system for assignment of UDIs according to the UDI Rule.



Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Tue, 27 Dec 2016 05:00:00 GMT

The FDA is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific recommendations contained...



Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals

Tue, 27 Dec 2016 05:00:00 GMT

FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers. These events, which range from smoke production and overheating to equipment fires and explosion,



Public Workshop - Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI), February 2, 2017

Tue, 27 Dec 2016 05:00:00 GMT

The purpose of the public workshop is to obtain stakeholders' input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on all aspects of the workshop topics which include...



Webinar - Postmarket Management of Cybersecurity in Medical Devices Final Guidance - January 12, 2017

Tue, 27 Dec 2016 05:00:00 GMT

On January 12, 2017, the FDA will host a webinar for industry to review, discuss and answer questions regarding the Postmarket Management of Cybersecurity in Medical Devices Final Guidance document.



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System

Fri, 23 Dec 2016 05:00:00 GMT

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.



Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Guidance for Industry and Food and Drug Administration Staff

Fri, 23 Dec 2016 05:00:00 GMT

FDA has developed this guidance document to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality1 and...



Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 046

Fri, 23 Dec 2016 05:00:00 GMT

The FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, ``Modifications to the List of Recognized Sta...



Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development

Fri, 23 Dec 2016 05:00:00 GMT

The FDA is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health intends to publish in fiscal year 2017. In addition, FDA has established a docket where intereste...



Federal Register: Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

Fri, 23 Dec 2016 05:00:00 GMT

The FDA is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codifi...



CDRH Fiscal Year 2017 (FY 2017) Proposed Guidance Development and Focused Retrospective Review of Final Guidance

Thu, 22 Dec 2016 05:00:00 GMT

The lists below include guidance documents that CDRH intends to publish this fiscal year (FY2017), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be..



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN150038, DEN150057 added)

Thu, 22 Dec 2016 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN150038, DEN150057 added)



FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication

Thu, 22 Dec 2016 05:00:00 GMT

The FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some..



Updated Information on 3D Printing of Medical Devices

Wed, 21 Dec 2016 05:00:00 GMT

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for simplicity. 3D...