Drug delivery devices are a specialty area within the medical device industry. These are combination products that may require review and approval by either device or drug agencies, or both. The end use of the device generally determines which agency will take the lead. Typical products are external or implanted pumps, implanted polymers with slow release or degradation properties, catheters with surface modifications, and materials such as bone cement. However, this device category can also include drug delivery patches and syringes. Thus, the approach to nonclinical evaluations may take a variety of directions.
The following scenarios regarding drug/device combinations are possible:
- The device and drug are approved and on the market individually.
- When the drug and the device are both approved, the biocompatibility of the device and the toxicology of the pharmaceutical are known. It must be shown that the stability and bioavailability of the drug have not been compromised by the new drug-device combination. Assays typically used to evaluate the drug product will be needed, as well as functional studies as indicated below.
- The device is approved, but the drug is not approved.
- When the device is approved and the drug is not, the drug will need to go through the extensive evaluations typically done for a new drug product, plus those studies indicated in the first scenario above.
- The device is not approved, but the drug is approved.
- NAMSA’s test program summary focuses on this scenario, since most of these devices today fall into a category where a known drug is available but the delivery system needs enhancement to achieve improved therapy.
- Neither the device nor the drug are approved.
- In this scenario, when neither drug nor device are approved, significant device evaluations (IDE, PMA) and drug evaluations (IND, NDA) will be required. Discussion with NAMSA Scientists and the FDA or Notified Body should precede testing in order to design the optimum test protocol.
Depending upon the exact nature of the device, a range of biological effects may need evaluation per ISO 10993. Please also see our guidance documents (link) for additional detail.
Our technical specialists and scientists are adept at developing nonclinical testing programs for these products.Veterinary surgeons on staff are experienced at implanting and evaluating the biocompatibility and functionality of such devices.
Standards and Regulation
First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993-1 should be consulted to determine areas of concern for these devices.
Each device should be examined on its own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that can be used to satisfy a portion of the safety requirements.
NOTE: In many cases, the drug portion of the combination product may be toxic to sensitive device methods. Therefore, in all cases except clinical like protocols and systemic toxicity, the device portion alone will be tested.
NOTE: This list provides an overview of tests that should be considered for combination & drug delivery systems—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.