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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: Tue, 28 Mar 2017 02:49:16 GMT

 



Class I Medical Device Recall: Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly

Fri, 24 Mar 2017 04:00:00 GMT

The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating...



CDRH's Experiential Learning Program

Thu, 23 Mar 2017 04:00:00 GMT

CDRH offers an innovative learning opportunity for new and experienced review staff. The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review...



Federal Register: Center for Devices and Radiological Health: Experiential Learning Program

Thu, 23 Mar 2017 04:00:00 GMT

The FDA is announcing the 2017 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, an...



Presentations posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Thu, 23 Mar 2017 04:00:00 GMT

Presentations posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee



Database for Reference Grade Microbial Sequences (FDA-ARGOS)

Wed, 22 Mar 2017 04:00:00 GMT

Many infectious diseases have similar signs and symptoms, making it challenging for healthcare providers to identify the disease-causing agent. Clinical samples are often tested by multiple test methods to help reveal the particular microbe that is...



Transcript posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Wed, 22 Mar 2017 04:00:00 GMT

Transcript posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee



24 Hour Summary posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Tue, 21 Mar 2017 04:00:00 GMT

24 Hour Summary posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption

Tue, 21 Mar 2017 04:00:00 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...



Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (Updated)

Tue, 21 Mar 2017 04:00:00 GMT

In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma...



Emergency Use Authorization - Gene-RADAR® Zika Virus Test (Nanobiosym Diagnostics, Inc.)

Tue, 21 Mar 2017 04:00:00 GMT

On March 20, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Nanobiosym Diagnostics, Inc.'s (Nanobiosym) Gene-RADAR® Zika Virus Test for the qualitative detection of RNA from Zika virus in human serum from individuals...



Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (Updated)

Tue, 21 Mar 2017 04:00:00 GMT

Through February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. There are 231 reports with data on surface information at the time of...



Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)

Tue, 21 Mar 2017 04:00:00 GMT

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals

Mon, 20 Mar 2017 04:00:00 GMT

The FDA is announcing an opportunity for public comment on the proposed collection of certain information - Medical Devices; Reports of Corrections and Removals - by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are ...



FDA Investigating Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers

Sat, 18 Mar 2017 04:00:00 GMT

The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated...



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification

Fri, 17 Mar 2017 04:00:00 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.



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices

Fri, 17 Mar 2017 04:00:00 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.



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey

Wed, 15 Mar 2017 04:00:00 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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning...



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case

Wed, 15 Mar 2017 04:00:00 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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning...



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products

Wed, 15 Mar 2017 04:00:00 GMT

The FDA is announcing that a proposed collection of information - Testing Communications on Medical Devices and Radiation-Emitting Products - has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork R...



Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Wed, 15 Mar 2017 04:00:00 GMT

The FDA is announcing that a proposed collection of information - Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use - has been submitted to OM...



Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure

Wed, 15 Mar 2017 04:00:00 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.



Check the CDRH Customer Satisfaction Results

Wed, 15 Mar 2017 04:00:00 GMT

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



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140038 and DEN130011 added)

Wed, 15 Mar 2017 04:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140038 and DEN130011 added)



Meeting materials posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Wed, 15 Mar 2017 04:00:00 GMT

Meeting materials posted for March 17, 2017 Ophthalmic Devices Panel of the Medical Devices Advisory Committee



Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display

Tue, 14 Mar 2017 04:00:00 GMT

The FDA is classifying the continuous glucose monitor secondary display 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 codified language for the continuous gluco...



Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use

Tue, 14 Mar 2017 04:00:00 GMT

The FDA is classifying the high throughput genomic sequence analyzer for clinical use 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 codified language for the cl...



Federal Register: Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments

Tue, 14 Mar 2017 04:00:00 GMT

The FDA has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accord...



Federal Register: Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device

Tue, 14 Mar 2017 04:00:00 GMT

The FDA is classifying the vibratory counter-stimulation device 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 codified language for the vibratory counter-stimul...



Class I Medical Device Recall: Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall

Tue, 14 Mar 2017 04:00:00 GMT

Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine.



FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017

Mon, 13 Mar 2017 04:00:00 GMT

The FDA is hosting a webinar on Wednesday, March 22 from 1:00 – 2:30 p.m. ET for developers and sponsors of neurological devices on the De Novo pathway, an alternate pathway to classify novel devices automatically placed in Class III after receiving...



FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication

Thu, 09 Mar 2017 05:00:00 GMT

The FDA wants to heighten awareness about the potential for bacterial contamination of SPS-1, and provide recommendations to health care facilities to help mitigate potential patient exposure to infectious bacteria. In addition, the FDA is calling...



FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication

Wed, 08 Mar 2017 05:00:00 GMT

TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. At least one physician, Dr. Michael Arata, claims the procedure treats the signs...



Class I Medical Device Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly

Wed, 08 Mar 2017 05:00:00 GMT

Physio-Control is recalling the LIFEPAK 1000 due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment. Physio-Control has determined that wear and oxidation formation between the battery and device...



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140033, DEN150035, DEN150055 and DEN160019 added)

Tue, 07 Mar 2017 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140033, DEN150035, DEN150055 and DEN160019 added)



1st Quarter FY 2017 MDUFA III Performance Report

Mon, 06 Mar 2017 05:00:00 GMT

1st Quarter FY 2017 MDUFA III Performance Report



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150007 and DEN160032 added)

Thu, 02 Mar 2017 05:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150007 and DEN160032 added)



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

Thu, 02 Mar 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.



Presentations posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

Thu, 02 Mar 2017 05:00:00 GMT

Presentations posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee



Federal Register: Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories

Wed, 01 Mar 2017 05:00:00 GMT

The FDA is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically inten...



MQSA National Statistics

Wed, 01 Mar 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.



Neurovascular Thrombus Retrieval Catheters and Guide Catheters Used During Neurological Interventional Procedures: Differences in FDA Review and Intended Use - Letter to Health Care Providers

Wed, 01 Mar 2017 05:00:00 GMT

To promote safe and effective use of medical devices, CDRH is clarifying the differences between neurovascular thrombus retrieval catheters and neurovascular guide catheters (e.g., intermediate catheter, distal access catheter).