Medical Device & Combination Products Team - Greenleaf Health

Daniel Schultz, M.D., F.A.C.S.

Principal, Medical Devices and Combination Products

Background:
- 20 years as a practicing physician/surgeon, 15 years at CDRH FDA regulating medical devices in the US and over a decade as Principal for Medical Devices and Combination Products at Greenleaf Health
Specialty:
- Specialist in medical devices and combination products
Experience:
- Patient care, device regulation at multiple levels within CDRH, consulting for industry on medical device regulation in the US

Dr. Daniel Schultz joined Greenleaf following a distinguished 35-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, and member of the US Public Health Service (USPHS). He has been recognized many times for his contributions and dedication to public health.

Dan continues his commitment to public health at Greenleaf as Principal of Medical Devices & Combination Products, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.

As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.

Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998–2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.

During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.

Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.

A New York City native, Dan is a graduate of the City College of New York. He received his M.D. from the University of Pittsburgh and is board certified in Surgery and Family Practice.

Catherine Rowe

Executive Director of Operations, Medical Devices and Combination Products

Background:
- 25 years of marketing, sales, and project management experience
Specialty:
- Specialist in marketing and operations

Catherine Rowe joined Greenleaf Health as Director of Operations, Medical Devices and Combination Products, with more than 18 years of professional experience. Catherine is responsible for managing multiple processes, including supporting, scheduling, and general operations management for members of Greenleaf’s team.

Before joining Greenleaf in 2014, Catherine served as a Senior Project Manager in the Operations Department at The Martin Agency, a top-five global advertising firm. In this role, Catherine managed multiple projects, including planning, scheduling, and training to implement a companywide workflow software platform.

Immediately preceding her work at The Martin Agency, Catherine was the Director of Operations for Game Consulting Group LLC and Movieswap LLC, video game and movie resellers. In this role, she cultivated multiple vendor relationships while managing the corporate budget and overseeing all product logistics. During her time at Game Consulting Group, Catherine contributed to sales growth from startup to more than $6.1M. Before her experience with Game Consulting Group LLC and Movieswap LLC, Catherine served as an Executive Assistant for more than 12 years to the President of Phillips Sales Inc., a company that represented manufacturers specializing in consumer entertainment. While in this role, she coordinated nationwide trade shows and assisted in managing a large customer base of software retailers.

Catherine began her career as a Marketing Coordinator for Pearl Izumi, a cycling apparel company, where she executed marketing media programs and organized industry trade shows.

Catherine is a graduate of The University of Virginia.

Heather Rosecrans, F.R.A.P.S

Executive Vice President, Medical Devices and Combination Products

Background:
- 30 plus years with the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) and over a decade as Executive Vice President for Medical Devices and Combination Products at Greenleaf Health
Specialty:
- Specialist in FDA’s 510(k) program and classification of Medical Devices
Experience:
- Extensive previous experience in the development, FDA premarket review and marketing of medical devices

Heather Rosecrans brings more than 40 years of public health and medical device experience to Greenleaf. She continues her commitment to public health by providing strategic consulting services and working with Greenleaf clients to deliver innovative devices to patients.

Before joining Greenleaf, Heather served as Director of the 510(k) Premarket Notification Staff at the FDA’s CDRH. In this role, she was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions, and other premarket regulatory requirements.

Heather started her FDA career as a biologist in the Bureau of Medical Devices. In 1980, she joined the newly organized CDRH Premarket Application (PMA) Staff. For the next 7 years, she coordinated the administrative, scientific, and regulatory review of PMAs, as well as product development protocols, master files and associated submissions.

In 1987, Heather joined the 510(k) Section of CDRH’s Program Operations Staff. In this role, she served as a Consumer Safety Officer and was a key contact for CDRH and within FDA on 510(k) matters. Heather held this position until 1992, when she became Director of the 510(k) Staff.

Heather’s accomplishments include drafting guidance documents and regulations on the 510(k) Program, training FDA staff and other stakeholders as well as assisting in the implementation of the Medical Device User Fee Modernization Act, the Food and Drug Administration Modernization Act and the Safe Medical Devices Act.

Heather’s extensive experience at CDRH—specifically her pivotal role in developing the 510(k) Program—enabled her to become one of the nation’s leading 510(k) experts. Since its inception in 1976, more than 150,000 510(k)s for devices have been reviewed for a determination regarding substantial equivalence via the program.

Heather has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with the Center for Medicare and Medicaid Services and other regulatory agencies.

Heather holds a B.S. in Biology from Pfeiffer College in Misenheimer, N.C.

Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products and General Counsel

Background:
- Nearly 15 years advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters
Specialty:
- FDA statutes, regulations, and policy
Experience:
- Joined Greenleaf after almost a decade of professional experience working in the food, drug, and medical device practice group at a large, multinational law firm

Maura Norden joined Greenleaf from the law firm Sidley Austin LLP in January 2015, following nearly a decade advising leading medical device and drug companies and investors on a broad range of FDA regulatory matters.

Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health organizations.

More specifically, Maura’s experience includes advising:

A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic;
In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues;
Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs);
Digital health companies on the FDA’s evolving approach to digital health products;
FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
Cosmetics companies with respect to permissible claims for cosmetic products;
Investors by providing strategic advice and conducting regulatory assessments in connection with due diligence for transactions and working with investors post-acquisition on integration activities; and
Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents.

Maura received her J.D., with honors, from the George Washington University Law School where she was an associate of The George Washington International Law Review. She received her B.A. from the University of Virginia where she was a Jefferson Scholar.

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Daniel Schultz, M.D., F.A.C.S.

Principal, Medical Devices and Combination Products

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Specialty:

Experience:

Catherine Rowe

Executive Director of Operations, Medical Devices and Combination Products

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Heather Rosecrans, F.R.A.P.S

Executive Vice President, Medical Devices and Combination Products

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Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products and General Counsel

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