What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap

FDA recently published its Predictive Toxicology Roadmap to enable the adoption of advances in toxicity testing. While this announcement from FDA may not have any immediate effects on the toxicology testing for medical device manufacturers (MDMs), it anticipates the future evolution of toxicology testing. With the unprecedented advancements in technologies, globalization, and ever-changing challenges, FDA and other stakeholders must have a unified, comprehensive strategy. FDA’s Toxicology Working Group recommended a six-part roadmap to achieve the goal of upgrading toxicology tools and their regulatory acceptance for medical devices, pharmaceuticals, and food.

The roadmap is anticipated to help move low-risk products to market faster while preventing products with objectionable toxicological risk from ever reaching the market. Furthermore, this approach falls directly in line with FDA’s and MDMs’ goals of refining, reducing, and replacing testing on animals. The roadmap affords MDMs the pursuit of further communication with the agency in support of incorporating new toxicology methods as part of the regulatory submission process.

Toxicology testing, part of the suite of biocompatibility testing required in the medical device field, plays a pivotal role in ensuring the safety of medical devices. This testing has received an increased amount of attention by FDA over the past few years; reviewers are paying closer attention to ensure the inclusion of novel toxicology testing with submissions now more than ever. FDA’s risk-based approach to determine what biocompatibility testing is needed as explained in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is supported in FDA’s roadmap. Continued communication by MDMs with FDA is critical for the acceptance of new toxicology methods in regulatory risk assessments and submissions.

Research and collaboration are integral components of FDA’s roadmap. MDMs, contract research organizations (CROs), and regulatory agencies must collectively work together to ensure that collaborative partnerships are developed to pursue and support the development, qualification, and validation of new predictive toxicology methods. Such collaborations as DARPA/FDA/NCATS on the novel organ-on-a-chip project and the collaborative efforts of CROs on the development of an in vitro alternative to the in vivo skin irritation test are prime examples of the momentum needed to further new methods in predictive toxicology.

Though new methods are being developed, it is important to note that the implementation is not always simple. FDA states: “There must be sufficient convincing data to ensure that the method can be relied upon for both product development and regulatory decision making.” Additionally: “a comprehensive strategy is needed to evaluate new methodologies and technologies for their potential to offer greater predictive ability.” These two declarations are necessary for the success and safety of the enactment and use of novel predictive toxicology methods in regular submission practice.

While medical device toxicology testing may not see all the effects of this newly proposed roadmap in the immediate future, in time, with more research and collaborations taking place in the science of toxicology, advancements will affect toxicology testing requirements for medical devices. Advancements are already being seen in the revisions of the ISO 10993 series with the use of extractable/leachable chemical characterization and computational methods (QSAR) in lieu of the traditional in vivo testing for medical devices, and certainly there are more advancements to come as FDA unifies its efforts with this newly created roadmap.

Nelson Labs is hosting a day-long workshop on February 7 at MD&M West 2018 in Anaheim. Topics include medical device biocompatibility testing, cleaning, sterilization, and packaging. Nelson Labs will also be at MD&M Booth #3029.