FDAnews Announces — FDA’s New Device Reclassification Process: How New Criteria May Impact Your Device Webinar, May 22, 2014

Just a few weeks ago, the FDA issued proposed regulations that allow it to reclassify a device by administrative order rather than by regulation. To help devicemakers get a handle on the changes, FDAnews has engaged three experts from Morgan Lewis FDA Practice to lead this webinar.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) May 08, 2014

FDA’s New Device Reclassification Process:
How New Criteria May Impact Your Device
**FDAnews Webinar**
May 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ReclassificationProcess

Just a few weeks ago, the FDA issued proposed regulations that allow it to reclassify a device by administrative order rather than by regulation.

It's a significant change that the agency hopes will bring clarity to the classification and reclassification process.

By modifying the Class III device definition, the FDA is trying to be clearer about which devices now classified as Class III cannot be "down-classified." And which ones can.

But there's more. "New information" could result in a device being "up-classified." But some "automatically classified" devices might be down-classified.

And yes, "pre-amendment" devices will be affected by the new proposed regulations.

To help devicemakers get a handle on the changes, FDAnews has engaged three experts from Morgan Lewis FDA Practice to lead this webinar.

In an intensive 90-minute session, they'll take attendees by the hand and walk them step-by-step through the complexities of the proposed regulations.

To do this, they'll present two distinct, detailed flow charts that will make comparing the old and the new classification and reclassification processes significantly easier:

Flowchart #1 will review the current reclassification process, in use prior to the issuance of the proposed regulatory changes.

Flowchart #2 will outline the new proposed reclassification process, as initiated by the FDA (or by a petitioner).

Clearly, this in-depth webinar is a must for device manufacturers. So, clear the calendar for early afternoon on Thursday, May 22, 2014, and plan to attend.

Meet the Presenters:
Beth Bierman has more than 25 years of representing domestic and international companies regarding FDA policies with Morgan Lewis FDA Practice where she is a partner.

Phoebe Mounts is a partner in Morgan Lewis FDA Practice with more than 16 years of professional experience regarding public health.

Michele Buenafe is an associate in Morgan Lewis FDA Practice where she focuses on state and federal regulatory regulations, compliance, and enforcement issues related to medical devices, health IT, pharmaceuticals, controlled substances and human tissue products.

Who Will Benefit:

  •     Regulatory affairs
  •     Product lifecycle management professionals
  •     Legal counsel
  •     Compliance officers
  •     Quality and risk management professionals

Conference Details:
FDA’s New Device Reclassification Process:
How New Criteria May Impact Your Device
**FDAnews Webinar**
May 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ReclassificationProcess

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

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