Washington DC, 25 May 2016 – Hogan Lovells announced today that Dr. Herbert Lerner, Deputy Director of the Division of Reproductive, Gastro-Renal and Urological Devices at the Food and Drug Administration (FDA), will join the firm on 1 July as Senior Director of Medical and Regulatory Affairs in its Medical Device Practice Group.
In his new role at Hogan Lovells, Dr. Lerner will assist the firm’s more than 700 medical device clients in developing strategies for obtaining market authorization for new technologies. He will also work with the firm’s attorneys and other non-lawyer regulatory specialists and scientists in relation to the design of clinical trials to support device clearances and approvals and with regard to medical device advisory panel meetings.
Dr. Lerner will join the firm following an accomplished 13-year career at FDA, where he oversaw medical device reviews in connection with premarket approval applications, 510(k) notices, de novo petitions, and investigational device exemption applications for reproductive, gastro-renal, and urological devices used in in hospitals, doctor offices, or by patients in their homes. He also led FDA efforts to improve the regulation of devices for the treatment of obesity. In previous positions at FDA, Dr. Lerner was involved in the premarket and medical reviews of many other types of devices including dermal fillers, breast implants, and a variety of medical scopes.
Prior to joining FDA, Dr. Lerner worked in private medical practice for 16 years at North Broward Surgical Associates, where he performed general and colorectal surgery. He did his residency in general surgery at the Beth Israel Medical Center in New York and Mount Sinai Medical Center in Florida, and a colorectal surgery fellowship at the Carle Clinic, Champagne, Illinois.
“We welcome Dr. Lerner to our practice and we are certain he will be of invaluable assistance to our clients in navigating the FDA premarket processes for new technologies. He will join a number of other former FDA officials at Hogan Lovells who for many years have successfully assisted our clients in obtaining market authorization for their products ”, said Janice Hogan, co-director of the Medical Device Practice Group
Hogan Lovells’ Medical Device Practice Group operates on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and streamline regulatory approvals. Many of the firm’s lawyers have worked for regulatory agencies and in private industry, and have backgrounds in biostatistics, medicine, public health, immunology, biomedical engineering, material science, and genetics, among other disciplines.
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