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.
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). Additionally, Greenleaf has expertise to help sponsors determine the regulatory identity (classification) of their product as a drug, device, biological product, or combination product.
Our experts have extensive experience with:
- Single-entity, co-packaged, and cross-labeled combination products
- Drug-coated devices
- A wide range of drug delivery systems including subcutaneous, inhaled, injected, topical, intrathecal, and closed loop
- Designation and development of companion diagnostics
Greenleaf supports companies developing combination products with the following services:
Litigation Support
Greenleaf’s deep bench and network 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 combination products. We can provide authoritative, objective expert opinions that may make a difference in how disputes are resolved and can also serve in a consulting capacity to identify key FDA regulatory issues that may impact litigation strategy.
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.
Advisory Services
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.
Cosmetics Regulatory Services
Greenleaf works with clients to clarify and support compliance with the regulatory requirements for consumer products marketed in the cosmetics space.
Success Stories
Medical Device & Combination Products Resources
View or download the PDFs below to learn more about Greenleaf and our capabilities in the areas of devices and combination products.
Connect With an Expert
Greenleaf’s Medical Device & Combination Products Team is ready to help you achieve your regulatory goals. Please provide the information below and a team member will be in contact.