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Combination Products

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Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

Combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

C. Humphrey & Associates, P.A.  is an FDA Law Firm that represents domestic and international companies regarding a range of regulatory medical device law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of medical device product development and marketing. We have represented medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance.  

Our FDA Lawyers and FDA Consultants assist in array of FDA Legal Services for manufacturers and distributors of medical devices including:

  • Clinical trials of medical devices under Investigational Device Exemption (IDE) regulations

  • FDA classifications of medical devices and labeling issues

  • Preparation of pre-market approval applications (PMAs), 510(k) Notifications and Humanitarian Device Exemptions (HDEs)

  • Establishment registration and listing applications

  • Combination products

  • Medical Device Reports (MDRs), product recalls, market withdrawals, FDA site inspections and Quality System Regulation (QSR)  requirements

  • Development of pre-market approval and FDA clearance strategies

  • Drafting and negotiating clinical trial, lab services, manufacturing and supply agreements

  • FDA Import Alerts for Medical Devices

  • Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls

  • FDA Inspections for Medical Devices

  • Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA  criminal and civil penalties)

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