Tag: Medical Devices

3
Jun

Global Adverse Event Databases

The United States Food and Drug Administration Mandatory Reporting According to Applicable Regulations Drugs and Biologics Drugs – FDA Adverse Event Reporting System (FAERS) Data Files Devices Medical Devices – MAUDE (Manufacturer and User Facility Device Experience) Vaccine Adverse Event Reporting System Australia – Therapeutic Goods Administration Database of Adverse Event Notifications (DAEN) The Therapeutic Goods Administration (TGA) receives adverse event reports associated with

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9
Jul

Labeling and Safety Testing Recommendations for Heparin Containing Products

FDA Draft Guidance Heparin-Containing Medical Devices and Combination Products Recommendations for Labeling and Safety Testing This guidance document is being distributed for comment purposes only. Document issued on: July 9, 2015 The United States Pharmacopeia (USP)* drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious

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16
Aug

India CDSCO: Regulatory Information for Medical Devices and Drugs

India Central Drugs Standard Control Organization (CDSCO) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Medical Devices and Diagnostic Division You may visit India CDSCO’s Medical Device Division here. List of Notified Medical Devices and Guidelines of Import and Manufacture of Medical Devices [members] India CDSCO List of Notified Medical Devices Clearification on Guidelines of Import and Manufacture of Medical

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20
Jul

LIVE Webinar: Medical Device Risk Management: Systematic and Holistic Approaches

LIVE Seminar | Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches Title: Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches Date: starting from September 15, 2014 This seminar recurs bi-monthly on second Mondays. Monday, September 15, 2014 Monday, November 17, 2014 Monday, January 12, 2015 Monday, March 16, 2015 Monday, May 18, 2015 Monday,

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24
Jun

Medical Device Adverse Event Reporting in EU, Health Canada and FDA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter Here is a list of applicable guidances from EU Commission, Health Canada and US FDA.  The following will be helpful when you establish and maintain your adequate procedures for reporting medical device adverse events in EU, Canada and US. European Union (EU) EU MEDDEV 2.12/1 Rev 8, January 2013 Health Canada 2011 October Health Canada Mandatory

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26
Mar

LIVE Audio Conference: Designing An Effective Cleaning Validation

Please get $20 discount by using the code “David20“ Live Audio Conference Designing An Effective Cleaning Validation For Reusable Medical Devices In Today’s Regulatory Environment Speaker: Dr. David Lim, Ph.D., RAC, ASQ-CQA Tuesday, April 22, 2014 | 1 pm ET | 60 Minutes REGISTER NOW Effective Cleaning Validation For Reusable Medical Devices This session is intended to discuss points of

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22
Nov

Class III Designation De Novo and Illumina MiSeqDx Platform

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Pursuant to the Food and Drug Administration Modernization Act of 1997 (FDAMA), FDA 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. The De Novo process applies to low and moderate risk

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20
Nov

510k Continuous Flush Catheters and PET

By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook 510(k) Continuous Flush Catheters and Peripheral Embolization Technology (PET) Direxion Torqueable Microcatheter Proprietary Shaft Design Enables Better Control In Hard-To-Navigate Vessels Boston Scientific receives FDA Clearance for the Direxion Torqueable Microcatheter.  It is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. Regulations 21 CFR PART 870 —

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18
Nov

Medical Device for Epilepsy Approved

Medical Device for Epilepsy Approved | NeuroPace RNS System By Regulatory Doctor; LinkedIn; Google Plus; Twitter FDA PMA | P100026 NeuroPace RNS® System for Epilepsy On November 14, 2013, the US FDA approved the NeuroPace RNS system, a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications. [animate duration=”7″ delay=”3″][youtube url=”http://www.youtube.com/watch?v=YQeGq_L_QO8&feature=youtu.be”][/animate] The RNS Stimulator consists

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13
Nov

FDA Advisory Panel Unanimously Voted for the Approval of Nuclear Hybrid L24 Implant System

FDA Advisory Panel Unanimously Voted for the Approval of Nuclear Hybrid L24 Implant System By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 26, 2014 FDA PMA | P130016 | Nucleur Hybrid L24 Implant System EAR, NOSE AND THROAT (ENT) DEVICES PANEL of the  MEDICAL DEVICES ADVISORY COMMITTEE Nucleus® Hybrid™ L24 Implant System | Cochlear Americas On November 8,

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