Device Research Humanitarian Use Device Emergency Use

Nov 03, 2012

530 likes | 693 Views

2. Investigational Device Exemption (IDE) Overview. . 3. Topics. Provision of IDE regulationsMedical device definitionWhen is an IDE not neededWhen is an IDE requiredSignificant risk (SR) deviceNon-significant risk (NSR) deviceNon compliance. 4. Provisions of the IDE Regulation - 21 CFR 812.

Share Presentation

Embed Code

Link

skylar

Download Presentation

Device Research Humanitarian Use Device Emergency Use

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

Humanitarian Use Devices – HUDs and Humanitarian Device Exemption - HDEs

Humanitarian Use Devices – HUDs and Humanitarian Device Exemption - HDEs. National Institutes of Health Product Life Cycle of an Investigational Device Exemption. Eric Chen Director Humanitarian Use Devices Designation Program Office of Orphan Products Development

1.08k views • 15 slides

Humanitarian Use Devices

Theodore Stevens, MS, RAC Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research. Humanitarian Use Devices. September 23, 2011. Section 520(m) of the Food, Drug and Cosmetic Act.

293 views • 18 slides

Humanitarian Device Exemptions (HDE) 101

Humanitarian Device Exemptions (HDE) 101. Elizabeth Hillebrenner, MSE Biomedical Engineer IDE and HDE Program Staff Center for Devices and Radiological Health. Humanitarian Use Device.

565 views • 19 slides

Wireless Portable Emergency Sensing Device

Wireless Portable Emergency Sensing Device. Group 10 Steven Garrett, Param Vora , Collin Liu ECE 445 : Senior Design. Presentation Outline. Introduction Device Features Hardware Design Pulse Oximeter Accelerometer Bluetooth Battery Circuit Nexus One® Interface Ethics. Competitors

529 views • 31 slides

Satellite Emergency Notification Device (SEND)

Satellite Emergency Notification Device (SEND). LCDR Mark Turner United States Coast Guard Office of Search and Rescue. Commercial Satellite Devices. Radio Technical Commission for Maritime Services (RTCM)

381 views • 22 slides

Mobile Device Use: Broadening and Building Positive Emotion

Mobile Device Use: Broadening and Building Positive Emotion . Patrick Curry Michael Milovich Liang Yu PhD Students in Information Systems Baylor University 24 April 2012. Introduction. Business Usage. Personal Usage. Introduction. May cause social dilemma.

426 views • 25 slides

Device(-to-Device) Authentication

Device(-to-Device) Authentication. Nitesh Saxena Polytechnic University. The Problem: “Pairing”. How to bootstrap secure communication between Alice’s and Bob’s devices when they have no prior context no common trusted CA or TTP. Examples (single user setting)

558 views • 36 slides

FDT Use Cases ( beyond device configuration )

FDT Use Cases ( beyond device configuration ). … uploads and downloads device parameters. ... a Frame Application that …. … opens DTM user interfaces for offline or online parameterization. … has a Tree View on left hand side that shows hierachical ordered network topology.

727 views • 54 slides

Mobile Device Use and Standardized Test Scores

Mobile Device Use and Standardized Test Scores. By: Cameron Johnson EDIT 6900 Spring 2013. Numerous studies have been conducted that determine: that mobile learning is a growing trend in schools and in the workplace how best to teach using mobile learning (Allen, 2011). The Problem.

318 views • 13 slides

While you wait, use your device

While you wait, use your device . Who is Neil?. Dr. Neil Heffernan Associate Professor of Computer Science Co-Director, Learning Sciences & Technologies Graduate Program Teach For America Teacher Over 50 Peer- Reviewed Empirical Studies Writes Grants Does Research

383 views • 30 slides

Emergency Ventilator Device

Emergency Ventilator Device. Group 12 Advisor: Dr. Paul King James Grotting Tim Weaver Ryan Winter Josh Gess Whitt Israel. Prototyping. Device – 1:18 cold-rolled plate of steel Prototype – PVC piping Cheaper Easy access to pre-cut tubing Same effect as steel. Prototype.

245 views • 7 slides

Device(-to-Device) Authentication

Device(-to-Device) Authentication. Nitesh Saxena Polytechnic Institute of NYU. The Problem: “Pairing”. How to bootstrap secure communication between Alice’s and Bob’s devices when they have no prior context no common trusted CA or TTP. Examples (single user setting)

765 views • 43 slides

Home Device Emergency Use Case

Home Device Emergency Use Case. Richard Crawford (OS/ASPR) (CTR) Allison Kumar (FDA/CDRH) Suzanne Schwartz (FDA/CDRH) Jianchoa Zeng (FDA/CDRH). -Use Case- Emergency Device Status.

293 views • 6 slides

EMERGENCY ALARM DEVICE

EMERGENCY ALARM DEVICE. Chadwick Becker – CprE James Jarvis – CprE Daji Qiao – Faculty Advisor. Dec05-11 Client: Iowa State University Website: http://seniord.ee.iastate.edu/dec0511/. Zachariah Varney – EE Salman Zafar – EE Randy Geiger – Technical Advisor. Project Requirements.

129 views • 1 slides

Understanding Mobile Handheld Device Use and Adoption

Understanding Mobile Handheld Device Use and Adoption. 董佳雯张馨元陈博. An Exploratory research project IPO Model Input : user characteristics, message/task characteristics… Process ： two interacting use subprocesses of exploration and experimentation, assessment

367 views • 18 slides

Home Use Laser Device for Bright Elegant Anatomy

Most men and women desire to have bright elegant anatomy and for this they use various devices and methods for ensuring the same. There is also a considerable growth of home use light based devices in recent times. People suffering from overweight and obesity use weight loss machines. Others use devices for peeling.

94 views • 4 slides

Use of Cerebral Protection Device

Keystone Heart develops Cerebral Protection Devices, which are used by doctors to reduce the risk of brain stroke during cardiovascular procedures.

123 views • 10 slides

HOW TO USE SCREEN TIME ON YOUR DEVICE

In the time of technology, parents may have to face a lot of problems as well as ensure that the loved ones are completely safe by controlling the time of the screen. It is necessary to restrict and monitor what they can do and with the help of the screen time, you may control the familyu2019s devices. Apple has added more tools on the Screen Time for parents in iOS 13. If you want to set up, then you are on the right post. Go through the blog and follow the instructions to customize the screen time. origin Source : https://quick-enbooks-info.com/blog/how-to-use-screen-time-on-your-device/

79 views • 6 slides

Device Research

Device Research. Presented by Marian Serge, R.N. Goals. Identify devices Recognize difference between significant risk (SR) and non-significant risk (NSR) devices Explain how an Investigational Device Exemption (IDE) is obtained for SR and NSR devices Discuss IRB responsibilities

284 views • 26 slides

Office.com/setup - Use Microsoft Office on any device

Office.com/setup - The complete package of applications which you can run on any type of device and access it from anywhere in the world. Using tool OneDrive it becomes easy to collaborate or share your work and makes the work you do available to you from anywhere.visit on https://mynew-office.com/

63 views • 5 slides

Single-Use Medical Device Reprocessing Market Research and Forecast 2020-2026

The increase in the demand for surgical procedures over the past few years has led the growth of the single-use medical device reprocessing market across the globe. With the improvements in surgical techniques, the minimally invasive procedures have been fulfilling the requirement of smaller incisions and the procedure typically produce less post-surgical pain, superior results, and faster recoveries. The regular transformations are expected to be seen in the field of cardiovascular surgery due to the advent of minimally invasive cardiac surgery (MICS). This

72 views • 5 slides

Why Use Mojipic Device

There are many reasons for using Mojipic. It lets you enjoy your ride by making you express your mood. Mojipic has 1500 emojis, smiles and GIFs to choose from. Apart from that, being voice-controlled, it keeps your hands free while driving. You can use it in the car or at home.

82 views • 7 slides

More Related