Tag: 510K

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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23
Sep

FDA Orders Oral Electronic Vision Aid to Be Class II Device

The Food and Drug Administration (FDA)  Oral Electronic Vision Aid The FDA is classifying the oral electronic vision aid 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 oral electronic vision aid’s classification. The Agency is classifying the device into

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22
Sep

Steerable Cardiac Ablation Catheter Remote Control System

FDA Medical Device Classification De Novo 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 substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. Section

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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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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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25
Jul

FDA Traditional 510k Guidance

FDA Guidance for Industry and Food and Drug Administration Staff The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications Issued: July 28, 2014 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled  “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” This guidance document describes FDA’s current review practices for premarket notification (510(k)) submissions by

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2
Dec

Total Product Life Cycle for Infusion Pumps 510k Contents

Infusion Pumps FDA Total Product Life Cycle (TPLC) Guidance By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) The US Food and Drug Administration (FDA) 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

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16
Oct

FDA 510k eSubmissions Pilot Program Accepting Limited Requests

510(k) eSubmissions Pilot Program (“Pilot Program or Pilot Submissions”) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) FDA is now accepting limited requests to participate in the CDRH 510(k) eSubmissions Pilot. As the Pilot Program is a new voluntary route for submitting 510(k) applications, the program provides guidance to the user through constructing and submitting a 510(k) submission electronically, eliminating

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29
Jul

FDA Issued Final Guidance for The Traditional 510k Program

FDA Guidance for Industry  The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Issued: July 28, 2014 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled  “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” FDA Guidance PDF download is available at https://www.fda.gov/media/82395/download This guidance document describes FDA’s current review practices for premarket notification

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7
Jul

Anti-Snoring Device

Anti-Snoring Device Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea 21 CFR 872.5570 Product Code: LRK Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the

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