In late 2018, FDA announced several bold proposals aimed at modernizing the 510(k) process that are likely to grab the attention of plaintiff’s lawyers and affect product liability litigation strategies. The proposals came in the wake of criticism that the existing 510(k) program does not adequately safeguard the public health. This webinar will discuss FDA’s proposed reforms, which include:
- Discouraging the use of older predicates by publishing a “shaming list” of devices that have been cleared based on predicates that are more than 10 years old
- Expanding the Abbreviated 510(k) program to include a “Safety and Performance Based Pathway,” which would allow a company to demonstrate that a device is as safe and effective as a predicate by meeting certain modernized performance criteria set by the agency
The webinar will also discuss how these proposed reforms could affect product liability litigation and strategies device companies can take to blunt potential negative impacts.
Wednesday, January 16, 2019
1:00 P.M. – 2:00 P.M. ET
CLE credit will be applied for in CA, GA, IL, NY, TX and, if needed, NC and VA. Attendees will receive a Uniform Certificate of Attendance via email approximately 30 days after the program to seek CLE credit in other jurisdictions. New York lawyers: This program is considered transitional and non-transitional in content. The interactive webinar format is synchronous and approved for all lawyers. King & Spalding LLP / 1180 Peachtree Street, Atlanta, GA 30309 | CA Provider # 10947.
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If you have questions concerning this Roundtable Webinar, e-mail firstname.lastname@example.org.