Med Device Online Launches New Guest Column Series On Optimizing FDA Submissions

Med Device Online announces the launch of an exclusive guest column series entitled Optimizing FDA Submissions: Leveraging Current Trends And Initiatives. Authored by Janice Hogan of Hogan Lovells US LLP, the quarterly series will unpack U.S. medical device regulations and provide recommendations for overcome premarket regulatory hurdles. The first installment, How Will Conducting A Medical Device Clinical Trial Outside The U.S. Impact Your FDA Approval?, is now live on Med Device Online.

Hogan is a partner and co-director of the FDA/Medical Device Practice at Hogans Lovells. Her work focuses primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA). She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation, and medical device products liability.

A biomedical engineer trained at the Massachusetts Institute of Technology (MIT), Hogan has served as an adjunct professor and lecturer at multiple academic institutions on the development and regulation of medical products. She is also a frequent lecturer at FDA regulatory law symposia and at conferences on topics related to premarket approval of medical products, combination products regulation, and product development, and has served on the faculty of FDA's staff college training for new review staff.

“Based on my experience with hundreds of FDA premarket submissions over the years, together with analysis of data on current submission trends, I hope to help Med Device Online readers implement strategies designed to optimize the submission and review process,” Hogan said.

“FDA submission challenges continue to be among the biggest barriers to commercialization for new medical devices and diagnostic technologies,” Jim Pomager, Med Device Online’s executive editor, said. ”We are thrilled to have someone with Janice Hogan’s expertise share to share insights and best practices on how to overcome premarket regulatory challenges. Her new series aligns with our goal of helping medical device companies get life-saving and -improving technologies to market more quickly and efficiently.”

Hogan joins Med Device Online’s rapidly growing lineup of guest expert contributors. For the latest industry viewpoints from Hogan and others, visit the Industry Perspectives section of Med Device Online.

About Med Device Online
Med Device Online is the leading online community serving professionals in the medical device and diagnostics industry. Our mission is to facilitate connections and foster collaborations in medical device development, to get life-improving therapies to market more efficiently. Med Device Online is part of the Life Science Connect (www.lifescienceconnect.com) business of VertMarkets, Inc. For more information, visit www.meddeviceonline.com

About Hogan Lovells
Hogan Lovells is a leading global law firm providing business-oriented legal advice and high-quality service across its exceptional breadth of practices to clients around the world. For more information, visit www.hoganlovells.com.