One of the important steps in the medical device development process is the demonstration that it is safe to use or to administer the product to humans. The process can sometimes be difficult because this demonstration of safety is typically limited to the use of preclinical in vitro and in vivo studies, including animal toxicology studies. In order to carry out this task, consideration must be given to the FDA (or other country) regulatory process, the appropriate FDA and ISO guidance’s, general principles related to proper toxicology study design, specific safety considerations related to the product class, additional safety concerns obtained from a careful scientific review of the pharmacodynamics and mechanism of action of the product, if appropriate, and an analysis of the risk-benefit issues associated with the product. The product commercialization cannot proceed until preclinical toxicology (i.e., biocompatibility) study results that support safe use or administration of the product to humans are submitted to the FDA in a 510(k), IDE or PMA. For complex products, it is recommended that this process involve continuous communication with the FDA, including a pre-submission meeting.
The services Walker Downey & Associates, Inc. provides are diverse and vary from one individual consultant to another based on the consultant’s expertise and experience. For the majority of our clients, we provide a toxicity testing strategy for a new or changed product that complies with regional or international regulatory requirements. Most often this includes a review of evidential literature to address issues related to chronic toxicity and carcinogenicity in an attempt to reduce or eliminate this testing for permanent implant materials. However, Walker Downey & Associates, Inc. can also prepare simple protocols for non-clinical safety studies and work with laboratories to ensure that they are being conducted properly. We can also interpret and summarize the results of toxicology studies to help prepare the regulatory submissions. Our Associates have many years of experience in their fields including: