Jennifer D. Newberger
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
• A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory Violation,
September 7, 2016
• Commercialisation of Healthcare Global Guide,
January 19, 2016
• 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,
• FDANews Webinar: FDA’s Office of Combination Products: Deciphering FDA’s Jurisdictional Determinations, August 11, 2016
• FDA-Regulated Entities: Compliance and Enforcement Strategies, FDA Deskbook: A Compliance and Enforcement Guide, April 28, 2016
• ABA Family Law 2015 Spring CLE Conference, Fragile: Handle with Care! (Importing and Exporting of Gametes, The Hurdles and Ethical Implications" (Jennifer Newberger's topic to be determined)), May 6-9, 2015
• FDLI Introduction to Medical Device Law & Regulations, Registration and Listing, April 3 - 4, 2013
• FDLI: Introduction to Medical Device Law and Regulation, Clinical Investigations, March 12 - 13, 2012
see more blog entries
• FDA Finalizes its Guidance Regarding Medical Device Accessories,
January 9, 2017
• 21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used In Healthcare,
January 2, 2017
• Highlights of Medical Device Related Provision in the 21st Century Cures Act,
December 8, 2016j
• FDA Tones Down MDR Reporting Recommendations in its Final Guidance,
November 16, 2016
• FDA Issues Separate Draft Guidance Regarding Software Modifications,
August 30, 2016