The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
De Novo Submissions– Bethany Hills, Chair, FDA Practice (Video)
Mintz
Contributor
Mintz is a general practice, full-service Am Law 100 law firm with more than 600 attorneys. We are headquartered in Boston and have additional US offices in Los Angeles, Miami, New York City, San Diego, San Francisco, and Washington, DC, as well as an office in Toronto, Canada.
Bethany Hills, Chair of Mintz Levin's FDA Practice, discusses the difference between a de novo submissions and 510k submissions, and the benefits of utilizing the de novo pathway.
