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| Food and Drug Adminstration (FDA): CDRHNew |
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| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority |
(Fri, 10 Feb 2012)
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| 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. |
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| Evaluation of Automatic Class III Designation (De Novo) Decision : K112394 added |
(Fri, 10 Feb 2012)
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| The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. |
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| FDA Safety Communication: Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units |
(Fri, 10 Feb 2012)
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| The FDA is issuing this communication to alert health care providers, including dentists, dental care professionals and veterinarians, about the illegal sale of hand-held dental X-ray units that have not been reviewed by the FDA. The FDA is concerned... |
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| Transcripts of January 11, 2012 Gastroenterology-Urology Devices Panel Meeting |
(Fri, 10 Feb 2012)
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| The Gastroenterology-Urology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology and nephrology devices... |
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| Meeting Materials for the Neurological Devices Panel meeting to be held on 2/10/12 |
(Wed, 08 Feb 2012)
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| The Neurological Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics ... |
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| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices |
(Mon, 06 Feb 2012)
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| 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. |
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| Federal Register: Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching; Public Workshop |
(Mon, 06 Feb 2012)
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| The purpose of this public workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as to collect comments and input... |
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| Public Workshop - Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching, March 8-9, 2012 |
(Mon, 06 Feb 2012)
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| The purpose of this workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as collect comments and input regarding when... |
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| Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016 |
(Thu, 02 Feb 2012)
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| The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial.. |
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| Summary Information for: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator |
(Thu, 02 Feb 2012)
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| Labeling, Approval Order, and Summary of Safety and Effectiveness for Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator (P110016). |
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| Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added |
(Sun, 29 Jan 2012)
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| The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. |
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| Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available) |
(Sat, 28 Jan 2012)
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| A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. |
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| Summary Information for: M-Vu Algorithm Engine |
(Fri, 27 Jan 2012)
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| Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005). |
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| Consumer Information on: M-Vu Algorithm Engine - P100005 |
(Fri, 27 Jan 2012)
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| The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o |
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| FDA Report on MDUFMA / MDUFA Performance, October 21, 2011 (PDF) |
(Wed, 25 Jan 2012)
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| FDA Report on MDUFMA / MDUFA Performance, October 21, 2011 |
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| Summary Information for: MelaFind® |
(Wed, 25 Jan 2012)
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| Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012). |
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| Federal Register: Pediatric Medical Devices; Public Workshop; Reopening of Comment Period |
(Wed, 25 Jan 2012)
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| The FDA is reopening until March 5, 2012, the comment period for the notice entitled Pediatric Medical Devices; Public Workshop; Request for Comments that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463). |
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| PMA Final Decisions for December 2011 |
(Wed, 25 Jan 2012)
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| These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for December 2011. |
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| Summary Information for: ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems |
(Tue, 24 Jan 2012)
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| Labeling, Approval Order, and Summary of Safety and Effectiveness for ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems (P100039). |
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| Consumer Information on: ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems - P100039 |
(Tue, 24 Jan 2012)
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| ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection. |
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| CDRH 2012 Strategic Priorities |
(Tue, 24 Jan 2012)
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| As we release our 2012 Strategic Priorities, we are proud to report on our accomplishments from 2011. We completed work on fifty action items in 2011. Highlights of the significant amount of work our staff accomplished in 2011 include... |
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| CDRH Ombudsman Annual Report - Calendar Year 2011 |
(Tue, 24 Jan 2012)
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| An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an... |
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| Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available). |
(Mon, 23 Jan 2012)
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| A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. |
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| Summary Information for: GORE TAG Thoracic Endoprosthesis |
(Thu, 19 Jan 2012)
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| Labeling, Approval Order, and Summary of Safety and Effectiveness for GORE TAG Thoracic Endoprosthesis (P040043S040). |
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| Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040 |
(Thu, 19 Jan 2012)
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| The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include... |
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF) |
(Wed, 18 Jan 2012)
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| This guidance document provides to you, sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND), recommendations about certain information that should be included in a submission describing a... |
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| Federal Register: Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended To Repair or Replace Knee Cartilage; Availability |
(Wed, 18 Jan 2012)
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| The guidance document provides sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND) recommendations about certain information that should be included in a submission describing a product... |
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| Evaluation of Automatic Class III Designation (De Novo) Decision Summaries: K102333 added |
(Sat, 14 Jan 2012)
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| The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. |
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| Evaluation of Automatic Class III Designation (De Novo) Decision : K080377 added |
(Fri, 13 Jan 2012)
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| The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. |
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| Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications |
(Fri, 13 Jan 2012)
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| The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's... |
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| Innovation Pathway |
(Thu, 12 Jan 2012)
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| The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. |
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| Class I Medical Device Recall: Respironics, Inc. Trilogy 100 Ventilators |
(Thu, 12 Jan 2012)
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| Trilogy 100 ventilators are being recalled due to a manufacturing issue. This issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy.. |
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