Combination Product Approval
According to the U.S. FDA:
Combination Products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.
The FDA has indicated that it 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).
The FDA has stated that “…because 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.”
Go here to review FAQs regarding FDA Combination Products
What are examples of Combination Products?
Examples of Combination Products where the components are physically, chemically or otherwise combined:
- Monoclonal antibody combined with a therapeutic drug Device coated or impregnated with a drug or biologic Drug-eluting stent;
- Pacing lead with steroid-coated tip;
- Catheter with antimicrobial coating;
- Condom with spermicide;
- Skin substitutes with cellular components;
- Orthopedic implant with growth factors;
- Prefilled syringes, insulin injector pens, metered dose inhalers, transdermal patches
Some products may be considered Combination Products simply because they are packaged together.
Examples of Combination Products where the components are packaged together:
- Photosensitizing drug and activating laser/light source;
- Iontophoretic drug delivery patch and controller;
- Drug or biological product packaged with a delivery device;
- Surgical tray with surgical instruments, drapes, and lidocaine or alcohol swabs
For other examples, and answers to questions regarding the official designation of proposed Combination Products, jurisdictional determination (which agency will lead the review of marketing applications), and relevant investigational regulations (IND,IDE), visit this site for the latest FDA Draft Guidance on this subject.