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 Development at EKG Labs
At EKG Labs, we have brought together industry experts in combination product development and regulatory 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?
- Are the materials in my product biocompatible?
- 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
- Method Development
- Method Validation
- Impurity Identification
EKG Labs Combination Product Expertise
The team at EKG Labs has worked with a variety of medical device combination products including:
- Drug-eluting stents
- Intraocular lenses and implants
- Dental implants and adhesives
- Metered dose inhalers, nebulizers, and other novel inhalation technology
- Wound-healing devices
- Filler devices
- Pumps and other drug delivery devices
- Cardiovascular devices
- Pulmonary devices
- Miscellaneous devices in accordance with ISO 10993 testing
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