Jennifer D. Newberger
J.D., magna cum laude, University of Miami School of Law
M.P.H., International Health, Emory University
B.A., with honors, Anthropology, Washington University in St. Louis
District of Columbia
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Jennifer D. Newberger helps medical device clients develop regulatory strategies, prepare product applications, comply with labeling, advertising, and promotion, and address enforcement actions. Ms. Newberger also works on combination product issues, and has expertise in FDA's regulation of human tissue-based products. She provides counsel on FDA aspects of regulatory due diligence, contracts, and transactions, and represents medical device companies before FDA.
As part of her regulatory work, Ms. Newberger prepares IDE, 510(k), de novo, and PMA submissions or filings. In the area of compliance, she advises clients on MDRs, recalls, and QSRs. She has worked with companies ranging from start-ups to small and large manufacturers.
Before joining the firm, Ms. Newberger was a policy advisor at FDA's Center for Devices and Radiological Health. Her knowledge of the government's internal processes and priorities guides her interpretation of emerging medical device regulation. Earlier in her career, Ms. Newberger was an associate in the health care group of a national firm.
• Helps clients develop regulatory strategies, including investigational device exemptions, 510(k) clearance, and PMA approvals.
• Handles appeals of premarket decisions, such as NSE letters.
• Advises companies on compliance with post-market regulations, including adverse event reporting, labeling and advertising, Part 806 (recall) reporting, QSR, and product modifications.
• Provides guidance on IDEs, clinical studies, and informed consent.
• Counsels clients on enforcement actions, including Form 483s, warning letters, product recalls, and injunctions.
• Advises companies on FDA regulation of software and mobile apps.
• Counsels medical device companies on compliance with labeling, advertising, and promotion regulations.
• Reviews contracts and security disclosure documents.
• Performs regulatory due diligence and post acquisition risk mitigation.
• Advises companies on product jurisdiction strategies.
HCT/P, Tissue Products
• Advises on whether products qualify for regulation solely as HCT/Ps under 21 CFR Part 1271.
• Provides counsel on GTPs, adverse reaction reporting and HCT/P deviation reporting.
Articles / Publications
see more articles
Thomson Reuters Book: Commercialisation of Health Care,
November 4, 2013
Draft Guidance on Medical Device Recalls: Improvements Are Needed,
July / August 2013
The US FDA and its Draft Guidance on Medical Device Appeals,
Summary of CMS Final Rule on Transparency Reporting,
February 12, 2013
A Year in Review: CDRH Draft Guidance Documents of 2011,
May / June 2012
FDLI Introduction to Medical Device Law & Regulations, April 3 - 4, 2013
Registration and Listing
FDLI: Introduction to Medical Device Law and Regulation, March 12 - 13, 2012
see more blog entries
FDA Finalizes Guidance Regarding IDE Decisions Without Pre-Decisional IDE Process,
September 10, 2014
CDRH Seeks to Clarify UDI Requirements,
August 27, 2014
FDA Issues Draft De Novo Guidance Incorporating FDASIA Modifications,
August 19, 2014
CDRH Issues Final Q&A About FDASIA Appeals Process,
August 5, 2014
CDRH Releases 2014-2015 Strategic Priorities,
February 12, 2014