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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 22, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss and make recommendations regarding the agency's regulatory strategy for Full Field Digital Mammography (FFDM) Devices.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 22, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Draft Guidances for Industry and FDA Staff; CADe 510(k) Draft Guidance and CADe Clinical Performance Assessment Draft GuidanceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
These draft guidances provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe) devices applied to radiology images and radiology device data and recommendations on how to design and...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems; AvailabilityEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document describes a means by which cardiac allograft gene expression profiling test systems may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test SystemsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The device is assigned the generic name 'Cardiac allograft gene expression profiling test system.' It is identified as a device that measures the RNA expression level of multiple genes and combines this information to yield a signature...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually IdentifiableEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and with ethical standards. Investigators should have freedom to pursue the least...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver ApplicationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Congress passed CLIA (Public Law 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance DevelopmentEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is announcing the Web location where it will post a list of guidance documents CDRH is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

FDA Consumer: A New Online Guide to Hearing AidsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Food and Drug Administration (FDA) has launched a new Web site that will benefit current and potential users of hearing aids.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submis.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] SubmissionsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test SystemsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document was developed as a special controls guidance to support the classification of cardiac allograft gene expression profiling test systems into class II (special controls). A cardiac allograft gene expression profiling test system is...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

FDA Consumer: Hearing Aids and Personal Sound Amplifiers: Know the DifferenceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
You've likely seen them advertised on television?small electronic sound amplifiers that allow users to enjoy nighttime TV without disturbing sleepers, or to hear their toddlers from many yards away...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Information on Hearing AidsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Having trouble hearing? Over 35 million children and adults in the United States have some degree of hearing loss. Hearing loss can have a negative effect on communication, relationships, school/work performance, and emotional well-being...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 20, 2009 Category: Medical Equipment Source Type: organizations

Safety Investigation of Certain Medical Device Power Cords: Initial CommunicationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
FDA is investigating whether certain types of power cords used with medical devices may be defective.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 19, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical DevicesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive; AvailabilityEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document describes a means by which wound dressing with Poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive may comply with the requirement of special controls for class II devices.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Devices; Plastic Surgery Devices; Classification of Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) AdditiveEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Food and Drug Administration (FDA) is classifying the wound dressing with pDADMAC additive into class II (special controls).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of Postponement of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is postponing the meeting of the NMQA Advisory Committee scheduled for November 2, 2009. The postponement is due to guidance documents planned for discussion at the meeting are not yet available.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Request for Nominations for Voting Members on Public Advisory Panels or CommitteesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2010.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On November 20, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 16, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Advancing Clinical Development of Molecular and Other Diagnostic Tests for Respiratory Tract Infections; Notice of Public WorkshopEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of the public workshop is to provide an opportunity to share information and perspectives with health care providers, academia, and industry on various aspects of diagnostic test development for respiratory infections.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 15, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 15, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) AdditiveEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document was developed as a special control guidance to support the classification of the wound dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) additive into class II (special controls).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 15, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A VirusesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 13, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Mammography Quality Standards Act Final Regulations, etc.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid AssayEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document was developed as a special controls guidance to support the classification of respiratory viral panel multiplex nucleic acid assays into class II (special controls).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex AssaysEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This document was developed as a special control to support the classification into class II (special controls) of respiratory viral panel multiplex nucleic acid assays that include detection and differentiation of Influenza A virus subtypes.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid AssaysEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This document was developed as a special controls guidance to support the classification into class II (special controls) of a respiratory viral panel multiplex nucleic acid assay that includes detection and identification of human metapneumovirus (hMPV).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Guidances for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Documents; Respiratory Viral Panel Multiplex Nucleic Acid Assay, etc.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
These guidance documents describe a means by which respiratory viral panel multiplex nucleic acid assays may comply with the requirement of special controls for class II devices.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Respiratory Viral Panel Multiplex Nucleic Acid AssayEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2009 Category: Medical Equipment Source Type: organizations

Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 8, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Availability: Implementation of Medical Device Establishment Registration, etc.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 8, 2009 Category: Medical Equipment Source Type: organizations

Safety Investigation of CT Brain Perfusion Scans: Initial NotificationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
FDA has become aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis and treatment of stroke.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 8, 2009 Category: Medical Equipment Source Type: organizations

Class I Medical Device Recall: Penumbra, Inc. Neuron 6F 070 Delivery Catheter (Original Version)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Neuron 6F 070 Delivery Catheter is a component of the Neuron Intracranial Access System, which is used by physicians to introduce medical devices into blood vessels.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 7, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance, Emergency Use Authorization of Medical ProductsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The draft guidance describes the agency's general recommendations and procedures for issuance of emergency use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3), which was amended by the...
Source: Food and Drug Adminstration (FDA): CDRHNew - October 6, 2009 Category: Medical Equipment Source Type: organizations

Summary Information for: DuraSeal Spine Sealant SystemEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Labeling, Approval Order, and Summary of Safety and Effectiveness for DuraSeal Spine Sealant System (P080013).
Source: Food and Drug Adminstration (FDA): CDRHNew - October 6, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA is publishing a list of 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 Division of Dockets Management.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 6, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On November 4, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Spine.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 6, 2009 Category: Medical Equipment Source Type: organizations

Consumer Information on: DuraSeal Spine Sealant System - P080013Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 6, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Food and Drug Administration Transparency Task Force; Public Meeting; Request for CommentsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
FDA is announcing a second public meeting to discuss issues related to transparency at the agency. The purpose of this public meeting is to receive detailed and in-depth comments on three specific issues related to transparency at FDA.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 5, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: National Mammography Quality Assurance Advisory Committee; Notice of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On November 2, 2009, the committee will discuss guidance documents issued since the last meeting. The committee will also receive updates on: Interventional mammography accreditation programs, recently approved alternative standards, facility inspection..
Source: Food and Drug Adminstration (FDA): CDRHNew - October 1, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Postmarketing Safety Reporting for Combination ProductsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products.
Source: Food and Drug Adminstration (FDA): CDRHNew - October 1, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and FDA Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Avail.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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.
Source: Food and Drug Adminstration (FDA): CDRHNew - September 30, 2009 Category: Medical Equipment Source Type: organizations

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDAEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This guidance document was developed as a special control guidance to support the reclassification of the antimicrobial susceptibility test (AST) system, when the device is a system employing short-term incubation (less than 16 hours) from class III...
Source: Food and Drug Adminstration (FDA): CDRHNew - September 25, 2009 Category: Medical Equipment Source Type: organizations

Class I Medical Device Recall: Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision KitEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Reason for Recall: The current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (known collectively as SC catheters) incorrectly states that SC catheters are intended to be used with Medtronic IsoMed constant-flow infusion...
Source: Food and Drug Adminstration (FDA): CDRHNew - September 24, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Current Good Manufacturing Practice Requirements for Combination ProductsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The FDA proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products.
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2009 Category: Medical Equipment Source Type: organizations

Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations, and vote on a premarket approval application for the Alair Bronchial Thermoplasty System sponsored by Asthmatx, Inc. The device is indicated for the treatment of severe persistent asthma in adults.
Source: Food and Drug Adminstration (FDA): CDRHNew - September 22, 2009 Category: Medical Equipment Source Type: organizations

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