Jennifer Agraz Henderson
Jennifer Henderson's extensive background in the health industry lets her strategically navigate U.S. Food and Drug Administration (FDA) regulatory matters for medical device companies — both premarket and postmarket. She helps medical device manufacturers obtain FDA clearance for innovative devices. Be it investigational device exemptions (IDEs), 510(k)s, de novo petitions, or premarket approvals (PMAs), she assists clients in all matters pertaining to premarket submissions.
As the industry has evolved, so has Jennifer's practice. She is well versed in the areas of FDA regulation of mobile health, medical apps, medical software, combination product jurisdictional issues, clinical trial conduct, Bioresearch Monitoring matters, medical device appeals, and conducting regulatory due diligence.
A key piece of Jennifer's practice is the advertising and promotion of medical devices, from traditional media platforms like print and TV ads to global websites and social media platforms. She helps clients in comprehensive audits of promotional materials and provides strategic advice regarding development of marketing strategies and procedures and policies. Jennifer is frequently asked to provide in-house training on advertising and promotional issues. She has also authored numerous articles on medical device regulation, advertising and promotion issues, and mobile health.
Jennifer learned the ins and outs of the industry at the Center for Integration of Medicine & Innovative Technology (CIMIT), a nonprofit consortium of the Harvard Medical Institutions and the Massachusetts Institute of Technology (MIT), dedicated to medical product innovation and development. She also held several academic positions, including Research Fellow and research associate, at Massachusetts General Hospital, as well as Instructor in Dermatology at Harvard Medical School.
Areas of Focus
Counsel to a U.S. publicly traded software company in the cross-border sale of a business unit.
Helped client obtain a favorable outcome on appeal for a resorbable mesh with antibiotic coating in a contested 510(k) notice.
Conducted full-day bioresearch monitoring training for global imaging device company.
Conducted comprehensive audit of advertising and promotional materials and policies for global device firm, including updating relevant SOPs.
Conducted comprehensive audit of device modifications for global orthopedic firm, including updating SOPs and developing remediation plan.