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.

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.

Our strategic consultation encompasses all aspects of development, clearance and approval, and marketing of FDA-regulated products:

  • FDA regulatory policies, programs, and procedures
  • Product development
  • Premarket review
  • Postmarket safety requirements
  • Market analysis for potential competition

Greenleaf provides specialized insight on:

  • FDA policies and procedures
  • Product jurisdiction
  • User fee requirements
  • Medical device advisory panel decisions and meeting preparation
  • Implementation of new FDA legislation, regulations, guidance documents, and FDA standard operating procedures

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:

  • Preparation and/or assistance with preparation of Requests for Designation (RFDs) and pre-RFDs to determine primary mode of action (PMOA) and lead FDA Center assignment for combination products; advice on strategies to help influence PMOA determination in line with company’s objectives
  • Strategic considerations in filing single vs. separate marketing application(s) for the drug, biological product, and/or device constituent parts of a combination product
  • Strategies to help avoid the need for cross-labeling of combination product constituent parts
  • Advice on strategies for post-approval changes and bridging strategies for combination products
  • Review of/recommendations for sufficiency of device design control documentation for combination products, including verification and validation plans, protocols, and reports for the device constituent part and combination product as a whole
  • Review of/recommendations for human factors plans, protocols, and reports for combination products, including comparative use protocols for generic combination products
  • Training in combination product statutory requirements, regulations, policies, and procedures
  • Assessment of regulatory precedents and guidance to inform desired regulatory outcomes
  • Advice on communications with the FDA, including help translating “CDER speak” into “CDRH speak” and vice versa
  • How to break logjams or obtain assistance navigating Centers
  • How to effectively work with the Office of Combination Products (OCP)
  • Review of/recommendations for responses to FDA deficiencies to investigational or marketing applications and responses to OCP questions on pre-RFD submissions
  • Review of/advice on company procedures to ensure compliance with regulatory requirements for combination products
  • Advice on the cGMP requirements for single-entity, co-packaged, and cross-labeled combination products, including how to comply with the quality system “call-out” requirements for drugs, devices, and biological products
  • Audits of company facilities for compliance with cGMP requirements for combination products
  • Advice on the postmarket reporting requirements for single-entity, co-packaged, and cross-labeled combination products
  • Training on both cGMP and postmarket reporting requirements for combination products

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.

Greenleaf can offer litigators a high-level institutional knowledge of the FDA as well as more granular expertise regarding FDA regulation of a variety of medical product types across the product lifecycle. We have extensive experience preparing expert declarations or reports and testifying during depositions and at trial.

With decades of experience working at the FDA in senior positions, Greenleaf professionals have the knowledge and qualifications required to explain and clarify FDA regulatory issues for our clients, the courts, and juries and are credible, persuasive expert witnesses. We offer in-depth expertise on:  

  • Medical device and combination product development
  • Premarket review process
  • Manufacturing
  • Product quality and safety
  • Compliance
  • Enforcement

Greenleaf’s team has worked with litigators engaged in a variety of disputes, including:

  • Complex commercial litigation
  • Unfair competition/false advertising cases
  • Intellectual property litigation
  • Product liability class actions
  • Securities class actions
  • Other types of litigation such as tax matters and contract disputes

Learn more about Greenleaf’s Litigation Support services

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.

Learn more about Greenleaf’s Digital Health services

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.

Learn more about Greenleaf’s Advisory services

Cosmetics Regulatory Services

Greenleaf works with clients to clarify and support compliance with the regulatory requirements for consumer products marketed in the cosmetics space.

Learn more about Greenleaf’s Cosmetics Regulatory services

Success Stories

  • 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 …

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.

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