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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: Thu, 29 Sep 2016 10:35:08 GMT

 



24 Hour Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting

Wed, 28 Sep 2016 04:00:00 GMT

24 Hour Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting



Class I Medical Device Recall: DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk

Wed, 28 Sep 2016 04:00:00 GMT

DePuy Synthes is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse...



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN110011 and DEN150056 added)

Wed, 28 Sep 2016 04:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN110011 and DEN150056 added)



Information on the Artificial Pancreas Device System

Wed, 28 Sep 2016 04:00:00 GMT

The FDA supports and fosters medical device innovation as it upholds its mission of ensuring that medical devices are safe and effective. The FDA is helping advance the development of an artificial pancreas device system, an innovative device that...



Presentation and Transcript added to Webinar - Final Guidance on Adaptive Designs for Medical Device Clinical Studies - September 22, 2016

Wed, 28 Sep 2016 04:00:00 GMT

On July 27, 2016, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance. It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical device development. This final guidance...



Presentations posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting

Wed, 28 Sep 2016 04:00:00 GMT

Presentations posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting



Consumer Information on: The 670G System - P160017

Wed, 28 Sep 2016 04:00:00 GMT

The Medtronic MiniMed 670G System is the first FDA approved hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user's glucose reading.



Updated the Expedited Access Pathway Program website with two Data Development Plan Examples

Wed, 28 Sep 2016 04:00:00 GMT

In April 2015, the FDA issued the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions guidance. This guidance introduced a new...



Emergency Use Authorization - Sentosa® SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)

Mon, 26 Sep 2016 04:00:00 GMT

On September 23, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Vela Diagnostics USA, Inc.'s Sentosa® SA ZIKV RT-PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine...



Federal Register: Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device

Thu, 22 Sep 2016 04:00:00 GMT

The FDA is classifying the strabismus detection 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 strabismus detection device's cla...



Meeting Notice: October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee

Thu, 22 Sep 2016 04:00:00 GMT

Meeting Notice: October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee



Federal Register: Technical Electronic Product Radiation Safety Standards Committee; Notice of Meeting

Thu, 22 Sep 2016 04:00:00 GMT

The FDA announces a forthcoming public advisory committee meeting of the Technical Electronic Product Radiation Safety Standards Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory...



Federal Register: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Wed, 21 Sep 2016 04:00:00 GMT

The FDA is announcing the availability of the draft guidance ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' This draft guidance is intended to assist drug sponsors and device manufacturers who are plan...



Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045

Wed, 21 Sep 2016 04:00:00 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 Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System

Wed, 21 Sep 2016 04:00:00 GMT

The FDA is classifying the Magnetic Surgical Instrument System 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 magnetic surgical instrum...



Presentation and Transcript posted for the Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies Webinar - Wednesday, September 14, 2016

Wed, 21 Sep 2016 04:00:00 GMT

As part of the FDA’s ongoing effort to assure patients and providers have timely and continued access to safe, effective, and high quality medical devices, the FDA is hosting a webinar for investigators and sponsors on how to move a product to the U.S...



Federal Register: Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

Wed, 21 Sep 2016 04:00:00 GMT

The FDA is announcing the availability of the guidance ``Reporting of Computational Modeling Studies in Medical Device Submissions.'' The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and c...



Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Tue, 20 Sep 2016 04:00:00 GMT

This guidance, when finalized, is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products...



FY2017 Regulatory Science Priorities

Tue, 20 Sep 2016 04:00:00 GMT

In 2015, CDRH published its first set of regulatory science priorities. We have since refined and improved the process for generating our priorities and are issuing our FY 2017 regulatory science priorities. The CDRH regulatory science priorities serve...



National Evaluation System for health Technology

Tue, 20 Sep 2016 04:00:00 GMT

The FDA is building the foundation for a National Evaluation System for health Technology (NEST) to more efficiently generate better evidence for medical device evaluation and regulatory decision-making.



Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff

Tue, 20 Sep 2016 04:00:00 GMT

For many years, computational modeling and simulation (CM&S) studies have been used by sponsors to support device design/development and have been reported in medical device submissions. These studies have traditionally been used in the areas of fluid...



24 Hour Summary posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting

Mon, 19 Sep 2016 04:00:00 GMT

24 Hour Summary posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting



Transcript posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting

Mon, 19 Sep 2016 04:00:00 GMT

Transcript posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System

Fri, 16 Sep 2016 04:00:00 GMT

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.



Meeting materials posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting

Fri, 16 Sep 2016 04:00:00 GMT

Meeting materials posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting



Check the CDRH Customer Satisfaction Results

Thu, 15 Sep 2016 04:00:00 GMT

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



Consumer Information on: Obalon Balloon System - P160001

Wed, 14 Sep 2016 04:00:00 GMT

The Obalon Balloon System is a weight-loss system that uses gastric balloons to occupy space in the stomach. The balloons are delivered to the stomach inside of a swallowable capsule that is attached to a thin (1 mm) inflation catheter...



Consumer Information on: VisuMax® Femtosecond Laser - P150040

Wed, 14 Sep 2016 04:00:00 GMT

The VisuMax® Femtosecond Laser is an ophthalmic surgical laser designed to create small cuts (incisions) in the transparent layer on the front of the eye (the cornea). It is used in the VisuMax® small-incision lenticule extraction or SMILE procedure...



Meeting materials posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting

Tue, 13 Sep 2016 04:00:00 GMT

Meeting materials posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting



Federal Register: 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability

Mon, 12 Sep 2016 04:00:00 GMT

The FDA is announcing the availability of the draft guidance ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under sect...



Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

Mon, 12 Sep 2016 04:00:00 GMT

The FDA is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.



510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

Fri, 09 Sep 2016 04:00:00 GMT

This draft guidance describes the recognition, rerecognition, recognition/rerecognition denial, and recognition withdrawal processes, including the associated criteria. The objective of this guidance is to encourage harmonization by incorporating...



Consumer Information on: Bard LifeStent Vascular Stent System - P070014S037

Fri, 09 Sep 2016 04:00:00 GMT

It is a metal stent to help blood flow to the legs. This nickel-titanium alloy (nitinol) stent is a tube cut with a laser to form a mesh. The mesh bends easily to fit the artery.



Consumer Information on: cobas® EGFR Mutation Test v2 - P150047

Fri, 09 Sep 2016 04:00:00 GMT

The cobas® EGFR Mutation Test v2 is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC). In normal tissue, the...



Consumer Information on: ImageReady MR Conditional Pacing System - P150012

Fri, 09 Sep 2016 04:00:00 GMT

It is a heart pacing therapy system for patients with slow heart rates. Doctors can scan some patients implanted with this device using magnetic resonance imaging (MRI). Thus, this device is MR conditional.



Consumer Information on: Juvéderm Volbella® XC - P110033S018

Fri, 09 Sep 2016 04:00:00 GMT

It is a dermal filler that can increase lip volume and smooth lines around the mouth in adults over the age of 21. Juvéderm Volbella XC It has crosslinked and other hyaluronic acid.



Consumer Information on: Raindrop® Near Vision Inlay - P150034

Fri, 09 Sep 2016 04:00:00 GMT

The Raindrop® Near Vision Inlay (the inlay) is a tiny device that is implanted in the cornea -- the clear, front surface of the eye.



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations

Thu, 08 Sep 2016 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, Federal Agencies are required to publish notice in the Federal Register concerning each...



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

Thu, 08 Sep 2016 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.



MDSAP Invitation - September 8, 2018

Thu, 08 Sep 2016 04:00:00 GMT

The Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) invites medical device :manufacturers to participate in our innovative regulatory single auctit program. The MDSAP Pilot, whkh started on 01 January, 2014, is the...



Posted Ten New MDSAP Education Modules in the “Postmarket Activities” section of CDRH Learn

Thu, 08 Sep 2016 04:00:00 GMT

Posted Ten New MDSAP Education Modules in the “Postmarket Activities” section of CDRH Learn



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization

Wed, 07 Sep 2016 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.



August 2016 PMA Approval List

Wed, 07 Sep 2016 04:00:00 GMT

August 2016 PMA Approval List



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

Wed, 07 Sep 2016 04:00:00 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...



September 7, 2016 MDUFA III Performance Report

Wed, 07 Sep 2016 04:00:00 GMT

September 7, 2016 MDUFA III Performance Report



The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication

Wed, 07 Sep 2016 04:00:00 GMT

The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are...



Transcript posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting

Wed, 07 Sep 2016 04:00:00 GMT

Transcript posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting



Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program

Tue, 06 Sep 2016 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 Federal Agencies are required to publish notice in the Federal Register concerning each p...



Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

Tue, 06 Sep 2016 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.



Class I Medical Device Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination

Tue, 06 Sep 2016 04:00:00 GMT

Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide recalled certain lots of material because of a potential contamination by glass particles. Cook received one lot of the affected recalled coating. Cook is...



Mammography Facility Adverse Event and Action Report - September 6, 2016: AdvancedTech Breast Imaging Specialists, LLC

Tue, 06 Sep 2016 04:00:00 GMT

As a condition of reaccreditation of this facility, the State of Illinois Certification Agency (SIL CA) requested that the facility’s accreditation body, the American College of Radiolgy (ACR), conduct a Full Additional Mammography Review (AMR). The...



UDI Extension Letter to Device Labelers - September 6, 2016

Tue, 06 Sep 2016 04:00:00 GMT

The Unique Device Identification rule (the UDI Rule) (78 FR 58786, September 24, 2013) establishes a system to adequately identify medical devices through their distribution and use via the supply chain to point of use with patients. The UDI Rule...



Essure - FDA Activities

Fri, 02 Sep 2016 04:00:00 GMT

The FDA has been examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs).



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150049 added)

Fri, 02 Sep 2016 04:00:00 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...



Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff

Thu, 01 Sep 2016 04:00:00 GMT

As solid state device technology continues to progress, solid state x-ray imaging devices will assume an ever-increasing role in medical x-ray systems. This evolution will result in a significant number of premarket (510(k)) submissions for devices...



Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication

Thu, 01 Sep 2016 04:00:00 GMT

The FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed.



Federal Register: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments

Thu, 01 Sep 2016 04:00:00 GMT

The FDA is announcing a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively 'firms'), regarding FDA-regulated drugs and medical devices for...



Meeting Notice: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Thu, 01 Sep 2016 04:00:00 GMT

Meeting Notice: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee



Federal Register: Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Thu, 01 Sep 2016 04:00:00 GMT

The FDA announces a forthcoming public advisory committee meeting of the Microbiology 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...



Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers

Thu, 01 Sep 2016 04:00:00 GMT

The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA).



Webinar - Final Guidance on Adaptive Designs for Medical Device Clinical Studies - September 22, 2016

Thu, 01 Sep 2016 04:00:00 GMT

On July 27, 2016, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance. It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical device development.



Webinar - Final Guidance on Patient Preference Information - September 27, 2016

Wed, 31 Aug 2016 04:00:00 GMT

This document outlines recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and patient advocacy organizations, can voluntarily collect and submit to FDA patient preference...



Federal Register: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Tue, 30 Aug 2016 04:00:00 GMT

This guidance describes the Agency's intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to finished devices that are...



Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150037 added)

Tue, 30 Aug 2016 04:00:00 GMT

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150037 added)