Janice M. Hogan
Partner
Philadelphia
Washington, D.C.

Biography
Janice Hogan has been involved in medical technology
for over 25 years. From her engineering training at theMassachusetts Institute of Technology to work in thepharmaceutical industry, to her current practicerepresenting medical device companies before the U.S.
Food and Drug Administration (FDA), Janice has
focused her career on the intersection of technology,regulation, and health care.
Widely recognized as a leader in FDA regulation ofdevices, Janice leverages her technical background tohelp companies with cutting-edge technologies
navigate and optimize the FDA approval process.
Janice focuses on FDA regulation of high-tech products
in women's health, diagnostics, neurology,cardiovascular, and orthopedics. She has assistedcompanies to obtain "first-of-a-kind" FDA approvals,
providing guidance on regulatory strategy, clinicalstudy design, advisory panel proceedings, and tools toexpedite product approval.
Janice brings her lifelong passion for science andinnovation to bear in her client advocacy. Through her
extensive experience representing companies in a wide
range of FDA interactions, Janice has been at theforefront of several of the most innovative medical
device approvals, including the first successful
FDA/Centers for Medicare and Medicaid Services
parallel review project, as well as first-in-classPhone+1 267 675 4611 (Philadelphia)+1 202 637 5600 (Washington, D.C.)

Fax+1 267 675 4601 (Philadelphia)+1 202 637 5910 (Washington, D.C.)

Emailjanice.hogan@hoganlovells.com

Languages
EnglishPractices
Medical Device and Technology
Regulatory

Industries
Life Sciences and Health Care

Areas of focus
Advisory Panel Preparation
Combination Products
In Vitro Diagnostics

approvals for devices used in treatment of breast
cancer, diabetes management, obesity, spinal surgery,and neurology, as well as a variety of drug/device
combination products. Janice also has substantial
experience using newer FDA approval mechanisms
such as the de novo process to reduce review time andbring products to market earlier, accelerating patient
access.

Medical Devices
Premarket Review
Cell, Tissue, and Gene Therapies

Awards and rankings

J.D., Georgetown University Law
Center, magna cum laude, Order ofthe Coif, 1995
B.S. Mechanical Engineering andLiterature, Massachusetts Institute ofTechnology, 1988

Healthcare: Life Sciences, Legal 500 US, 2014-2015,2017-2020
Most Highly Regarded Firm for Life Sciences 2018,
Who's Who Legal, 2018
Life Sciences Star, LMG Life Sciences, 2018
Who's Who Legal Life Sciences: Regulatory Lawyers,
Who's Who Legal, 2008-2018
Regulatory: Medical Devices, PLC Life Sciences Crossborder Handbook, 2011-2012

Latest thinking and eventsNews
FDA under fire: Pared-down LDT Final Rule leaves
unanswered questions
Hogan Lovells Events
J.P. Morgan Healthcare ConferenceAwards & rankings
LMG Life Sciences recognizes Hogan Lovells asRegulatory Firm of the Year for 2022
Press releases
Hogan Lovells advises CartiHeal in securing FDA
premarket approval for knee implant
News
COVID-19 Report for Life Sciences and Health Care
Companies
News
COVID-19 Report for Life Sciences and Health Care
Companies (Jan - Feb 2022)

Education and admissions
Education

Memberships
Member, American Bar Association
Member, Maryland State BarAssociation
Member, National Health Lawyers
Association

Bar admissions andqualifications
Pennsylvania
District of Columbia