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October 21, 2014

ABA Health Law Event: FDA Medical Device Law Fundamentals

Med Device ABA

On November 20, 2014, hear an experienced panel discuss FDA Medical Device Law Fundamentals. Policy & Medicine readers will enjoy an ABA Health Law Section discount. Please click here to register.

The discount code is AALNCFDA.

Understanding the unique language and role of the FDA is critical to all health lawyers, particularly those who may represent medical device or healthcare application developers or manufacturers.

In this webinar, a panel of experienced FDA attorneys will give you an overview of the responsibilities of the FDA and its impact on the medical device and healthcare mobile app approval.

Topics will include:

  • An introduction to the FDA and how it’s organized
  • The Basics of Device classification and what qualifies as a Medical Device and how that applies to Mobile Apps
  • The clinical trial, premarket approval, and 510(k) processes 

Panelists will also define many of the acronyms and terms unique to the FDA.  Attendees will come away with an understanding of what the FDA is looking for during the review process, as well as key regulatory requirements relating to labeling, post-market issues, advertising, reimbursement, adverse event reporting and recalls, and enforcement.

Date and Time: November 20, 2014. 12:00-1:30pm ET

Panelists:

Afia K Asamoah, Product counsel at Google Inc. Prior to joining Google, Asamoah was regulatory attorney at Covington & Burling LLP, advising pharmaceutical, biotechnology, and medical device clients on a range of FDA-related regulatory and compliance issues. Her work includes internal investigations and audits, legislative activities, interactions with regulatory bodies, and corporate transactions. 

Heather Rosecrans, Executive Vice President, Medical Device and Combination Products at Greenleaf Health; Vice President of Regulatory Affairs for the Medical Device Manufacturers Association. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). 

Laurie Clarke, Partner at Jones Day. Clarke is an FDA attorney who focuses on medical device regulation. She has extensive experience in device submissions and counsels medical device manufacturers regarding FDA laws and regulation. Clarke has also represented clients at meetings with the FDA and at FDA Advisory Committee hearings.

Moderator:

Abraham Gitterman, Associate Attorney at Arnold & Porter’s FDA and Healthcare Group in the firm’s Washington, D.C. office.

Credits:

1.50 General CLE Credit Hours

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