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 test...
Source: MDDI - Category: Medical Devices Authors: Tags: MD & M West (Anaheim) Testing Source Type: news