Medical Devices & Combination Products
To ensure success in today’s rapidly evolving medical technology industry, companies must recognize and be prepared for a dynamic regulatory landscape. Greenleaf’s unmatched knowledge of the FDA regulatory process and emerging trends equips companies of various sizes, stages, and industry segments with a trusted partner as they navigate the complexities of bringing medical technologies to market and manufacturing them to FDA quality standards.
Medical Device & Combination Products Team
Guided by former CDRH and OCP leadership and experts in the field, Greenleaf’s Medical Device and Combination Products Team provides strategic advice to clients throughout the product lifecycle.
Daniel Schultz, M.D., F.A.C.S.Principal, Medical Devices and Combination Products
Heather Rosecrans, F.R.A.P.SExecutive Vice President, Medical Devices and Combination Products
Maura M. Norden, J.D.Executive Vice President, Medical Devices and Combination Products and General Counsel
Mark KramerExecutive Vice President, Medical Devices and Combination Products
Samantha EakesVice President, Regulatory Affairs
Catherine RoweExecutive Director of Operations, Medical Devices and Combination Products
Our Medical Device & Combination Products Services
Strategic Regulatory Guidance
Greenleaf guides clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems.
Premarket Review Process
We apply extensive FDA experience to determine the best regulatory approach for a product and develop a comprehensive strategy to achieve a successful result. Our premarket review capabilities include:
- Scientific and regulatory strategies for clinical programs and regulatory submissions
- Recommendations and preparation for FDA meetings, including medical device advisory panel meetings
- FDA communications, including formal, in-person, and regulatory correspondence
Marketing and Promotional Practices
Greenleaf supports medical device firms with strategic review and guidance related to:
- Labeling requirements
- Promotional materials
- Direct-to-consumer advertising review processes
- Use of social media
- Remediation of untitled and warning letters
Combination Product Support Services
Greenleaf provides strategic advice throughout the combination product lifecycle, including all potential premarket pathways (NDA, ANDA, BLA, PMA, 510(k), De Novo). Our experts have extensive experience with drug-coated devices and a wide range of drug delivery systems including subcutaneous, inhaled, injected, topical, intrathecal, and closed loop. We also have knowledge and experience with designation and development of companion diagnostics.
Greenleaf supports companies developing combination products with the following services:
Greenleaf’s deep bench of experts work closely with litigators representing FDA-regulated clients in a wide array of disputes involving complex FDA issues related to medical devices and can provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.
Experts from Greenleaf’s Medical Device and Combination Products Team provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.
Digital Health Services
Greenleaf experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of FDA digital health requirements.
Providing Litigation Support That Led to a Favorable Judgment for a Device Start-Up Firm
A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would …
Planning and Supporting a Regulatory Strategy for De Novo and 510(k) Submissions
Greenleaf Health provided strategic and tactical advice to an early-stage start-up regarding their premarket submissions for a novel wound retraction system after the FDA determined that the company would need to follow the de novo pathway. The Greenleaf team assisted the company with development and submission of a de novo classification request for their product. …
Medical Device Auditing and Certification for Compliance with FDA Guidelines
Greenleaf was selected by a multinational medical device company to serve as an independent GMP and Medical Device Reporting (MDR) expert. In this role, Greenleaf was made responsible for performing initial audits and procedural reviews at the company’s locations in the U.S. and Asia. Greenleaf’s work started with a review of company policies and procedures; …
Helping a Digital Therapeutic Client Successfully Navigate the De Novo Regulatory Pathway
Greenleaf Health helped a digital therapeutic company developing cognitive treatments as it navigated the de novo classification request regulatory pathway. Greenleaf experts worked closely with the client to address FDA concerns and requests regarding the digital therapeutic device, helping to clarify the FDA’s questions and recommendations and assisting with drafting written correspondence to the Agency. With Greenleaf’s …
Contributing a Chapter on In Vitro Diagnostics to an FDLI Book Publication
Greenleaf Health was invited by a partner at a prominent D.C. law firm to write a chapter on in vitro diagnostics (IVDs) for inclusion in a book to be published by the Food and Drug Law Institute (FDLI). In vitro diagnostics have become an increasingly large part of Greenleaf’s portfolio of regulatory services, furthered by …
Conducting Due Diligence to Guide a Corporate Acquisition Decision
Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …
Collaborating to Streamline Review of a Complex PMA Submission
Greenleaf Health worked with a major orthopedic company to gain marketing authorization for a new formulation of an approved bone augmentation product. Due to the complex regulatory and scientific nature of this project, Greenleaf coordinated with a large team of in-house and external regulatory and scientific experts in order to devise the most advantageous strategy …
Achieving a Breakthrough Device Designation
Greenleaf Health worked with a multinational medical device company throughout the review and submission of a breakthrough device designation request for a device indicated for the minimally invasive treatment of lung tumors. The Greenleaf team provided strategic advice on how to frame the device description and indication for the breakthrough request in light of the …