Tag: Premarket Notification

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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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 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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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)].” This guidance document describes FDA’s current review practices for premarket notification (510(k)) submissions by describing in greater detail the

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9
Nov

Fish-Skin Tissue Regeneration Technology to Heal Human Wounds

By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook Fish-Skin Tissue Regeneration Technology to Heal Human Wounds On October 23, 2013, the US FDA cleared a 510(k) [K132343] to market a proprietary fish-skin technology, marketed as MariGen Omega3, for the treatment of chronic wounds in the US.  The MariGen Omega3 is manufactured by Kerecis in Iceland from fish locally harvested in the North Atlantic waters.

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6
Nov

Preamendment Class III Devices | Exempted Class I and Class II Devices

Preamendment Class III Devices | Exempted Class I and Class II Devices By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor; LinkedIn; Google Plus; Twitter) The April 9, 2009, Order applies to all manufacturers of the twenty-five (25) device types listed below. Learn more here. DEVICE TYPE CLASSIFICATION REGULATION (21 CFR XXX.XXX) CORRESPONDING PRODUCT CODE(s) Membrane lung for long-term pulmonary support 868.5610 BYS Intra-aortic

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22
Sep

Proton Therapy: Future of Cancer Treatment or a Pricey Mistake?

By Admin; LinkedIn; Google Plus; Twitter [NBC News] Proton Therapy: Future of Cancer Treatment or a Pricey Mistake? If you build it, will they pay? Plans to build a $235 million facility in New York City to treat cancer with proton-beam therapy are still proceeding—as are projects for new proton-beam centers around the country—even as some insurers balk at covering the pricier therapy

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11
Sep

510ks Combination Products Drug Wound Dressing

510(k)s for Combination Products and Drug Wound Dressing By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 26, 2014 FDA cleared twenty-five (25) 510(k)s under the product code “FRO” since January 2013 Pre-Amendment Devices Unclassified Total Product Life Cycle Report Since 1992 Learn about combination products at the link below. http://www.fda.gov/combinationproducts/default.htm Device Name Applicant 510(k) Number Decision

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11
Sep

List of 510(k)s Cleared with Clinical Trials

By Regulatory Doctor; LinkedIn; Google Plus; Twitter The following shows the list of 177 510(k)s cleared with clinical trials since 2009. Pursuant to 21 CFR § 807.92(a)(3), a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket

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