Mar 7, 2019   SOURCE: PR NewsWire

FDAnews Announces -- FDA's 2019 Medical Device Regulation Agenda: Are You PreparedWebinar, March 21, 2019

FALLS CHURCH, Va., March 7, 2019 /PRNewswire-PRWeb/ -- FDA's 2019 Medical Device Regulation Agenda
Are You Prepared
**An FDAnews Webinar**
Thursday, March 21, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/mdregagenda

What's the current status of pilot programs to provide for expedited approval?

What are the advantages and disadvantages of the current approval pathways?

What's on the agenda for the rest of 2019?

Jessica Ringel --Counsel, King & Spalding, Washington, D.C. -- will discuss how CDRH will prioritize digital health, advance device safety and security, offer more flexibility and options for premarket submissions, sustain high-quality servicing, provide efficient oversight, handle uncertainty in devices and engage patients. Attendees will learn about: 

    --  Recent revisions to the medical device guidance and activities required
        by the FDA Reauthorization Act (FDARA)
    --  Nuances pertaining to quality and regulatory professionals included in
        CDRH's FY 2019 guidance agenda -- with a recap of recently issued
        guidance and identification of what is ahead
    --  Status of the ever evolving, voluntary FDA pilot programs, including
        expectations for FDA's Digital Health Software Pre-Certification Program
        as it enters the 2019 test stage
    --  Current status of FDA's Case for Quality Voluntary Improvement Program

Understanding the FDA guidance... programs... and policies that may be on the horizon, as well as those that have been recently announced, will help prepare for changes in regulatory policy, and utilize advantageous programs.

Meet Your Presenter:
Jessica Ringel, Counsel, King & Spalding, Washington, D.C.,

Jessica Ringel is Counsel in the Washington, D.C., office of King & Spalding and a member of the FDA and Life Sciences practice. Jessica advises medical device and pharmaceutical companies on a wide variety of matters involving FDA regulation, both pre- and post-market. She specializes in post-market matters, including inspections, responses to FDA-483s and Warning Letters, recalls, and other enforcement actions. Jessica also regularly conducts due diligence reviews for manufacturers, private equity firms, and lenders in connection with mergers, acquisitions, investments, and other financial transactions.

Who Will Benefit: 

    --  Quality and regulatory professionals
    --  Operational and management
    --  Executive and strategic
    --  Legal and compliance

Webinar Details:
FDA's 2019 Medical Device Regulation Agenda
Are You Prepared
**An FDAnews Webinar**
Thursday, March 21, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/mdregagenda

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/mdregagenda
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.

SOURCE FDAnews