Navigation Links
FDAnews Announces — De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For? Webinar, Sept. 25, 2018
Date:9/12/2018

De Novo Strategies for Getting Your Medical Device Approved:
What is the FDA Really Looking For?
**An FDAnews Webinar**
Sept. 25, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/denovostrategies

What’s the best route for obtaining de novo classification?

What applications are being granted by the FDA?

What are the best practices to win approval?

These are some of the questions devicemakers need to ask when formulating their de novo approval strategy.

One of the best ways to win is to evaluate devices that have been brought to market via de novo. FDANews has invited two top FDA regulatory lawyers, Yarmela Pavlovic Esq. and Kelliann Payne Esq. of Hogan Lovells US LLP, to show devicemakers why and how to pursue it. Over the course of 90 informative minutes, attendees will:

  •     Understand the differences in regulatory pathways for more novel devices
  •     Be up to date on the current timelines associated with FDA clearance or approval of novel medical devices
  •     Be able to interpret recent de novo applications granted by FDA and best practices
  •     Learn how to evaluate examples of devices brought to market via the de novo classification process
  •     Understand the benefits of the pre-submission process for devices seeking de novo classification
  •     Be able to navigate potential pitfalls in the FDA clearance and approval process

Risks of the de novo approach are low. Within 120 days, the FDA will determine if a device is Class I or II and may issue an entirely new product code and regulation number. If rejected, the device simply remains Class III. Here’s a chance to see how de novo works.

Meet the Presenters:
Yarmela Pavlovic Esq. is Partner at Hogan Lovells US LLP focusing on device regulation and premarket strategies. She has particular experience with FDA regulation of digital and mobile health technology, as well as medical software and applications, and works toward strategic plans that comply with government regulations while achieving clients’ business objectives.

Kelliann Payne Esq. is Counsel at Hogan Lovells US LLP focusing on FDA regulation of diagnostic and therapeutic devices. She reviews the accuracy of marketing claims; helps clients with preclinical and clinical programs; and leads due diligence reviews for investments and acquisitions.

Who Will Benefit:

  •     Regulatory affairs/compliance
  •     Product lifecycle managers
  •     Approval and submissions specialists
  •     Medical affairs
  •     Legal counsel

Webinar Details:
De Novo Strategies for Getting Your Medical Device Approved:
What is the FDA Really Looking For?
**An FDAnews Webinar**
Sept. 25, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/denovostrategies

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/denovostrategies                        
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 https://www.prweb.com/releases/fdanews_announces_de_novo_strategies_for_getting_your_medical_device_approved_what_is_the_fda_really_looking_for_webinar_sept_25_2018/prweb15756902.htm.


'/>"/>
Source: PRWeb
Copyright©2018 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Announces — Top Tips for Establishing Device Supplier Quality Metrics Webinar, Sept. 12, 2018
2. FDAnews Announces — MDR Adverse Event Codes for Devicemakers Webinar, Aug. 14, 2018
3. FDAnews Announces — New Book — Clinical Trials Adverse Event Reporting Guide, 2017 Edition
4. FDAnews Announces — New Management Report — ClinicalTrials.gov: Mastering New Reporting Rules
5. FDAnews Database — Limited Time Offer Save $500 on 483sOnline.com
6. FDAnews Announces — New Management Report — Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort
7. FDAnews Announces — New Management Report — Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers
8. FDAnews Announces: Data Integrity: The Key to FDA and GMP Compliance, Dec. 5-6, 2017, Arlington, VA
9. FDAnews Announces — FDAnews Expert Insight Series: Device Regulation Under Gottlieb & Trump Webinar, Oct. 12, 2017
10. FDAnews Announces: Flawless FDA Inspection Handling and Response Preconference Workshop for the 12th Annual FDA Inspections Summit, November 1-3, 2017, Bethesda, MD
11. FDAnews Announces — Process Capability Indices for Medical Device Manufacturers Webinar, Sept. 26, 2017
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/12/2018)... ... September 12, 2018 , ... De Novo Strategies for Getting ... Sept. 25, 2018 — 1:30 p.m. – 3:00 p.m. ET, http://www.fdanews.com/denovostrategies ... being granted by the FDA? , What are the best practices to win approval? ...
(Date:9/12/2018)... , ... September 13, 2018 , ... Donaldson Plastic Surgery ... as well as Columbus Business First's Fast 50 list of central Ohio's fastest growing ... a 3-year growth rate of 81 percent. It is the only medical practice and ...
(Date:9/7/2018)... INDIANAPOLIS (PRWEB) , ... September 07, 2018 , ... Start ... with 12 different sports experiences from which to choose. Pedal power is the ... Collision Repair Drag Strip Experience or turning left on the miniature Indianapolis Motor Speedway ...
(Date:9/3/2018)... PA (PRWEB) , ... September 03, 2018 , ... Trees ... other hardwoods should be in full leaf and green through September. When a tree ... for winter before other trees of the same type. Giroud Tree and Lawn ...
(Date:9/1/2018)... ... 31, 2018 , ... “Vitamin D is the Key: The Myth, the Reality ... hot new release in Vitamins and Supplements, Medical Atlases, Vitamins, Medical References, and was ... tour around the United States. , With all the medical advancements over the last ...
Breaking Medicine News(10 mins):
(Date:9/1/2018)... ... August 31, 2018 , ... Precision Orthopedics & ... practice with offices in Irving and Southlake. Fellowship trained in Spine Surgery, Dr. ... Byung Lee, Dr. John Milani, Dr. Jaytinder Sandhu, and Dr. Tariq Hendawi beginning September ...
(Date:8/31/2018)... ... August 31, 2018 , ... Power Systems, a leading provider of ... brand, have partnered in a shared mission to motivate 100 million people to get ... on the rise since 2010, offering competitors a fun and complete physical challenge. Spartan ...
(Date:8/31/2018)... ... 31, 2018 , ... Travel tech specialist Aquarium Software has welcomed news that ... a new service for the disabled. The move is an admission that some consumers ... in the UK living with a disability, Aquarium Software says thoughts now need to ...
Breaking Medicine Technology: