Medical Devices

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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19
Oct

FDA Workshop Materials for PCLC Devices

FDA Public Workshop Materials Physiological Closed-Loop Controlled (PCLC) Devices October 13-14, 2015 The Food and Drug Administration (FDA) held a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The challenges related to the design, development, and evaluation of critical care PCLC devices were discussed. FDA considers PCLC devices an emerging technology and the workshop focused on design, development and performance

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15
Oct

Wireless Snoring Solution – NORA

NORA – the world’s first smart, non-invasive snoring solution It is currently under development. [youtube_advanced url=”https://www.youtube.com/watch?v=hsMJfS2vEYM” controls=”no” autoplay=”yes” rel=”no” modestbranding=”yes”] About NORA Nora is a wireless, noninvasive snoring solution. It is the first, smart device that’s designed specifically to stop snoring before it wakes your sleeping partner. With Nora, there is nothing to wear to bed—no masks, dentures, or nose strips.

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24
Sep

FDA Invites a Cancer Stethoscope Manufacturer for Discussion

FDA Sends a Letter Inviting Pathway Genomics for Discussion The Letter Is Intended to Discuss Safety Concerns for CancerIntercept Detect (aka Cancer Stethoscope) Pathway Genomics – Liquid Biopsy CancerIntercept [youtube_advanced url=”https://www.youtube.com/watch?v=ILvMvvYUego” controls=”no” autoplay=”yes” rel=”no”] President and CEO Pathway Genomics, Inc. 4755 Nexus Center Drive San Diego, CA 92121 Document Number: GEN1500674 Dear CEO: It has come to our attention that

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24
Sep

FDA Sends a Letter to a Cancer Screening Tool Developer

FDA Sends a Letter Inviting Pathway Genomics The Letter Is Intended to Discuss Safety Concerns for CancerIntercept Detect  Pathway Genomics – Liquid Biopsy CancerIntercept https://www.youtube.com/watch?v=ILvMvvYUego President and CEO Pathway Genomics, Inc. 4755 Nexus Center Drive San Diego, CA 92121 Document Number: GEN1500674 Dear CEO: It has come to our attention that you are currently marketing CancerIntercept Detect, which is a

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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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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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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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8
Jan

Representative Examples of Traditional Abbreviated and Special 510ks

January 2013 510k Clearances Representative Examples of 510(k)s Total 510(k)s:                                     224 Total With Summaries:                    210 Total With Statements:                     14 Traditional 510(k)s (Representative) Device: Colladental Barrier: 510(K) No: K100695 (Traditional) | SE Decision Made: 03-Jan-13 Device: Conventus Orthopaedics Fracture Fixation System | 510(K) No: K102689 (Traditional) | SE Decision Made: 17-Jan-13 Device: Therasom-Cast | 510(K) No: K113516 (Traditional) | SE Decision

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4
Sep

Improving Quality and Patient Safety with Recognition and Device Reporting

When Device Problems Are Noted, Recognize, Remove,  and Report By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) When medical device problems are noted at the healthcare facilities, it is important for healthcare providers to recognize and report device problems to the US food and drug administration. The following video can be used as an educational tool for healthcare staff in-service/training to

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