Tag: Medical Device

21
Apr

Improving Awareness of the Importance of Human Factors

Awareness Is Important FDA recently issued draft guidance entitled “List of Highest Priority Devices for Human Factors Review,” informing medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA or 510(k)). According to the guidance, it seems that FDA believes these device types have clear potential for serious harm resulting from use error, and that

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7
Dec

Diabetes Vascular Disease and Wound Care Products

Diabetes-Related Vascular and Wound Care Products FDA Approved Medical Products Drugs PLAVIX Plavix is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate

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20
Sep

Home Dental Cleaning System

Dental Air Force: Dental Cleaning System 21 CFR 872.6510 Oral Irrigation Unit An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition. Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part

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20
Mar

FDA Device Approval for Lixelle Beta 2-microglobulin Apheresis Column

Lixelle Beta 2-microglobulin Apheresis Column – H130001 Product Name: Lixelle Beta 2-microglobulin Apheresis Colum HDE Applicant: Kaneka Pharma America LLC Approval Date: March 5, 2015 for HDE (humanitarian device exemption application) FDA Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/H130001a.pdf The Lixelle Beta 2-microglobulin Apheresis Column (Lixelle Column) is a device that treats dialysis-related amyloidosis, a complication of kidney failure. The Lixelle Column contains specialized beads

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2
Dec

Total Product Life Cycle for Infusion Pumps 510k Contents

Infusion Pumps Total Product Life Cycle Guidance By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) The US Food and Drug Administration (FDA) has issued a final guidance, dated 2014-12-02, entitled “Infusion Pumps Total Product Life Cycle.” The guidance provides assistance to industry in preparing premarket submissions for infusion pumps and to identify device features that manufacturers should address throughout the total product

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29
Nov

UDI Examples of Medical Devices Under a Voluntary Device Correction

UDI Examples – Compliant or Non-Compliant? CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes. The labels of which are examples of UDI implementation by the CONMED Corporation. View more UDI labels of these products here. Compliance Issue The following UDI example is based on the GS1 system of standards.  As for the date format, UDI labels

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15
Feb

New Class III Device Approval for An Artificial Aortic Valve

A New Class III Device Approval for An Artificial Aortic Valve: CoreValve System – P130021 By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 21, 2014 An artificial aortic valve (often referred to as the CoreValve) implanted through a delivery catheter Product Name: Medtronic CoreValve System Manufacturer: Medtronic CoreValve LLC Approval Date: January 17, 2014 Approval Letter What is it?  The main

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4
Nov

Near Infrared Brain Hematoma Detector

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 28, 2014 A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas. 21 CFR 882.1935 Near Infrared (NIR) Brain Hematoma Detector. (a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive

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28
Oct

FDA Panel Voted for the Approval of ReSure Sealant

FDA Panel Voted for the Approval of ReSure Sealant  By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr) and Updated on December 29, 2014 P130004 | ReSure® Sealant |Ocular Therapeutix, Inc. September 19, 2013 Proposed Indication for Use (IFU) for the ReSure Sealant It is indicated for the intraoperative management of clear corneal incisions with a wound leak demonstrated

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10
Jul

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