What is a Combination Product?
According to the FDA, a combination product is composed of two or more different types of medical products such as a drug, device, and/or biological product with one another. Developing and submitting a combination product for regulatory approval can be a complicated and in-depth process. Each constituent part of the product needs to be investigated for safety as well as for how those constituent parts interact with each other. This requires specialty knowledge about material science, pharmaceutical development, and how those disciplines overlap in a regulatory environment.
Combination Product Testing at EKG Labs
At EKG Labs, we have brought together industry experts in combination product development and regulatory testing. EKG has experience with both Premarket Application (PMA) and 510(k) testing. Our team has unique understanding of how diverse materials can interact with each other and with pharmaceutical products. Some of the questions we can help you answer include:
- What is the extractables and leachables profile of my medical device?
- Does the pharmaceutical in my product negatively interact with the device materials?
- What data do I need to submit for regulatory approval of a combination device?
- How can potential impurities in my product be identified?
Our combination product development services include:
- Extractables & Leachables
- Biocompatibility (ISO 10993)
- Material Compatibility
- Impurity Identification
- Method Development
- Method Validation
EKG Labs Combination Product Testing Expertise
The team at EKG Labs has worked with a variety of medical device combination products including:
- Metered dose inhalers, nebulizers, and other novel inhalation technology (inhaler case study)
- Drug-eluting stents
- Dental implants and adhesives
- Wound-healing devices (microneedle case study)
- Filler devices
- Prefilled syringes (discoloration case study)
- Pumps and other drug delivery devices
Learn more about our specialty medical device experience
EKG Labs Material Expertise
We have experience working with diverse materials in a variety of medical device products. These materials include:
- Metals and Alloys
- Composite Materials
Learn more about our material expertise