Navigation Links
FDAnews Announces — Device Accessories – Understanding and Implementing the Final Guidance Webinar, March 23, 2017
Date:3/18/2017

Device Accessories – Understanding and Implementing the Final Guidance
**An FDAnews Webinar**
March 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/deviceaccessories            

Under the Food, Drug and Cosmetics Act (FD&CA) an accessory to a device is, itself, a device. But, it does not distinguish between accessories and other devices.

Manufacturers are struggling to figure out how to classify their device accessories.

On March 23, expert, Dan O’Leary, walks attendees through the final guidance issued on Dec. 30, 2016 to describe accessories and — in certain cases — provide a classification pathway.

The guidance document presents three major points of discussion:

1.    It describes what FDA considers as an accessory
2.    It explains how to apply the device classification system to accessories
3.    It covers issues of classification and reclassification with particular emphasis on using the de novo process for accessories not already classified.

Register today and learn to apply the guidance document to your products to determine if any of them are an accessory and ensure they meet device regulations.

BONUS: Attendees will receive a worksheet to help apply the definitions and determine if the accessory is classified as well as a copy of the guidance document.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  •     Product Marketing Specialists
  •     Regulatory Affairs Specialists
  •     Device Quality Specialists
  •     Design Engineering Managers
  •     Production Managers
  •     Product Documentation Specialists
  •     Risk Management Specialists

Webinar Details:
Device Accessories – Understanding and Implementing the Final Guidance
**An FDAnews Webinar**
March 23, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/deviceaccessories            

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/deviceaccessories                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/deviceaccessories/prweb14162103.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... As health professionals work to improve their approach to healthcare, ... doing more than filling out a survey; in many cases health professionals and patients ... health care and research on the importance of active engagement with patients and members ...
(Date:10/13/2017)... ... 2017 , ... PurhealthRX , a leading Health and Nutrition Company, is ... to full spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing ... easily incorporated into liquid products, while reducing costs to end users. , The team ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer ... one of the most popular and least understood books in the Holy Scriptures, Revelation. ... descriptions that have baffled scholars for centuries. Many have tossed it off as mere ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the ... published author, William Nowers. Captain Nowers and his wife, Millie, have six children, ... in the Navy. Following his career as a naval aviator and carrier pilot, ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... Oct. 11, 2017  True Health, a leader ... its effort during National Breast Cancer Awareness month ... risks. Research ... calculated that more than 10 million American women ... in BRCA1 or BRCA2 and have not had testing. ...
(Date:10/5/2017)... 2017  In response to the nationwide opioid ... Surgeons (AAOMS) released prescribing recommendations that urge ibuprofen ... as a first-line therapy to manage a patient,s ... Recognizing the value and importance of ... Prescribing: Acute and Postoperative Pain Management" stresses that ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: