Tag: CDRH

16
Dec

First of Kind Military Wound Dressing Cleared for Civilian Use

Food and Drug Administration (FDA) Clearance for Traumatic Wound Dressing XSTAT 30 Wound Dressing FDA clears military traumatic wound dressing for use in the civilian population FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin

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12
Nov

FDA CDRH MDUFA III Performance Report

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) MDUFA III (FY 2013-2017) Performance Report for 4th Quarter of FY 2015 November 9, 2015 Table of Contents Section 1: PMA Originals and Panel Track Supplements DAGRID Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices DCD Division of Cardiovascular Devices DCTD Division

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15
Oct

FDA Workshop Materials for Medical Device Patient Labeling

Public Workshop – Medical Device Patient Labeling, September 29-30, 2015 The FDA has posted  workshop materials for the Medical Device Patient Labeling, the workshop of which was held on September 29-30, 2015. FDA access link is at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm If you wish to submit your comments regarding the public workshop, you may do so until October 30, 2015. Submit comments to:  http://www.regulations.gov      (Docket

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5
Oct

FDA Notifies the Industry Concerning Tyvek Products Made by Dupont

FDA Notifies the Industry Concerning DuPont’s New (Transition) Tyvek Products FDA/CDRH Email We are writing to notify you that on the basis of data submitted by DuPont, including testing of the functional performance of the product during medical device sterilization and maintenance of package integrity over time, the FDA has determined that DuPont’s new (Transition) Tyvek® products are functionally equivalent to

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30
Sep

FDA CDRH User Fees for 2016

The following user fees are for Fiscal Year 2016 (October 1, 2015 through September 30, 2016). FY16 User Fees (in U.S. Dollars) Application Type Standard Fee Small Business Fee† 510(k)‡ $5,228 $2,614 513(g) $3,529 $1,765 PMA, PDP, PMR, BLA $261,388 $65,347 panel-track supplement $196,041 $49,010 180-day supplement $39,208 $9,802 real-time supplement $18,297 $4,574 BLA efficacy supplement $261,388 $65,347 PMA annual

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24
Sep

FDA Invites a Cancer Stethoscope Manufacturer for Discussion

FDA Sends a Letter Inviting Pathway Genomics for Discussion The Letter Is Intended to Discuss Safety Concerns for CancerIntercept Detect (aka Cancer Stethoscope) Pathway Genomics – Liquid Biopsy CancerIntercept President and CEO Pathway Genomics, Inc. 4755 Nexus Center Drive San Diego, CA 92121 Document Number: GEN1500674 Dear CEO: It has come to our attention that you are currently marketing CancerIntercept

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24
Sep

FDA Sends a Letter to a Cancer Screening Tool Developer

FDA Sends a Letter Inviting Pathway Genomics The Letter Is Intended to Discuss Safety Concerns for CancerIntercept Detect  Pathway Genomics – Liquid Biopsy CancerIntercept https://www.youtube.com/watch?v=ILvMvvYUego President and CEO Pathway Genomics, Inc. 4755 Nexus Center Drive San Diego, CA 92121 Document Number: GEN1500674 Dear CEO: It has come to our attention that you are currently marketing CancerIntercept Detect, which is a

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3
Aug

Analysis for Recent Special 510K Clearances

FDA 510(k) Program Device Design Changes or Modifications Special 510(k) (It Can Be Called as a “510(k) Program for Incentives”) FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k). Please note: there are no provisions for a 510(k) amendment or supplement to the existing 510(k) and thus, a new 510(k) must

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3
Aug

FDA CDRH Guidance on Appeals Processes

FDA Guidance FDA/CDRH Appeals Processes Document issued on: May 17, 2013 The draft of this guidance document was issued on December 28, 2011. This document supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” February 1998 and “Resolving Scientific Disputes Concerning the the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance

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19
May

FDA Guidance for Electrosurgical Devices

FDA Guidance for Premarket Notification [510(k)] Submissions Electrosurgical Devices for General Surgery – Draft Guidance for Industry and Food and Drug Administration Staff FDA has developed this guidance document to assist industry in preparing premarket notification submissions [510(k)] for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the

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