Jeffrey N. Gibbs Medical device manufacturers routinely enter into contracts. These contracts can take a wide variety of forms, covering areas such as contract manufacturing, clinical investigations, monitoring clinical studies, product development, or product distribution. All of these factors are important and require careful attention. In fact, FDA issues often have sufficient commercial importance that they should be explicitly addressed in the contract. Many companies, however, are not attentive enough to FDA-related issues when drafting contracts.
Inappropriate changes can give rise to significant regulatory risks to the purchaser.
Even more worrisome, some changes could have adverse effects on the product, putting patients at risk. And yet, unnecessarily requiring prior written approval by the buyer, or imposing overly restrictive limitations, can unduly inhibit minor manufacturing changes or improvements. There is no set solution to these problems. While there can be a regulatory need to prevent certain types of changes from being made without prior written consent, there are many contractual variations on this theme. A device purchaser must consider how its own needs should be addressed in this setting, and negotiate the terms accordingly.