510(k)

22
Apr

FDA Proposes Ban on Electrical Stimulation Devices

Electrical Stimulation Devices (ESDs) ESDs Are Intended to Treat Self-injurious or Aggressive Behavior The United States Food and Drug Administration (FDA) is proposing ban on ESDs because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. Aversive conditioning devices were on the market prior to passage of the Medical

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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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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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1
Oct

FDA Clears A New Laser-Based Hearing Aid

The EarLens Contact Hearing Device (CHD) The Premarket Review Regulatory Pathway: De Novo Process The de novo is available for some low- to moderate-risk medical devices (when there are no predicate(s) available on the market). On September 29, 2015, the U.S. Food and Drug Administration allowed marketing of a new hearing aid (EarLens Contact Hearing Device or EarLens CHD) that uses

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4
Sep

Needle Free Fluid Injection Devices

Needle-Free Injectors or Injection Device Systems 21 CFR 880.5430 Nonelectrically powered fluid injector A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may

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4
Aug

FDA Updates Refuse to Accept Policy for 510(k)s

 Guidance for Industry and Food and Drug Administration Staff Document issued on: August 4, 2015 As of October 1, 2015, this document supersedes “Food and Drug Administration’s Refuse to Accept Policy for 510(k)s,” dated December 31, 2012, “Premarket Notification (510(k)) Refuse to Accept Policy,” dated June 30, 1993, and “510(k) Refuse to Accept Procedures (K94-1) blue book memo”, dated May 20, 1994. Refuse to

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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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27
Mar

In-Person 2-Day Seminar for 510ks and PMAs

How to Format Succinct and Comprehensive 510(k)s and PMAs 2 Day Seminar, April 9-10, 2015 Research Triangle, NC [button url=”https://www.globalcomplianceseminar.com/event/how-to-format-succinct-and-comprehensive-510ks-and-pmas/?instance_id=15132″ target=”blank” style=”3d” background=”#c91119″ size=”10″ wide=”yes” center=”yes”]Recorded version is available here[/button] Overview This seminar will discuss the 510(k) and PMA submissions and will walk you through how to format a succinct and comprehensive 510(k) and premarket approval (PMA) application to increase

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13
Nov

FDA 510k Clearances October 2014

Summary of October 2014 510(k) Clearances TOTAL 510(k)s THIS PERIOD:                          264 TOTAL WITH 510(k) SUMMARIES:                254 TOTAL WITH 510(k) STATEMENTS:                10 510(k) Types Abbreviated 510(k)s:            8 Special 510(k)s:  

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