In April, FDA issued a white paper announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced artificial intelligence (AI) algorithms. We’ll discuss how FDA’s proposed approach would allow modifications to algorithms to be made from real-world learning and adaptation that accommodates the iterative nature of AI products while ensuring that FDA’s standards for safety and effectiveness are maintained.
Speakers:
ANISA MOHANTY is an associate at McDermott Will & Emery LLP in Washington, DC. She advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Anisa also assists clients with US Food and Drug Administration (FDA) engagement strategies and responding to FDA administrative and enforcement actions. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions, and other transactions involving FDA-regulated products as well as issues related to disclosure and periodic reporting.Registration
This program is limited to those who are a part of NFDL. This complimentary program includes a light lunch. Please register by July 29 to reserve your spot.
New to Food and Drug Law Group
The New to Food and Drug Law Group (NFDL) offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Paige Samson.
Location
McDermott Will & Emery LLP
The McDermott Building
500 North Capitol Street, NW
Washington, DC 20001
Program Host
