ISO 10993, published in 2009, set the standard for a risk-based approach to medical device safety. FDA adopted this standard and released their own enforcement guidance, FDA Guidance on ISO 10993, in June 2016. One year later, the agency is in harmony and equal enforcement of this guidance across reviewers and product types.
To device manufacturers, the FDA repeatedly communicates the need for compliance to ISO 10993-18: Chemical characterization of materials, for guidance on how to perform the chemical characterization analysis. Device manufacturers continuously look to their regulatory partners, including contract research organizations (CRO), for guidance on regulatory compliance.
It is, now more than ever, extremely important to pick the right partner for regulatory submission. The regulatory industry is at an all-time high in both its requests for Additional Information (AI) letters and time required to obtain regulatory clearance. Working with the right partner, can not only save you time to market but also provide the highest likelihood for submission success done right the first time.
Medical device manufacturers must consider chemical characterization for all devices – regulatory agencies expect this. It is also imperative that the chemistry data is quantitative and sensitive enough to allow for chemical identification. FDA’s concern is for the safety of the finished medical device. In order to understand the device safety, extractables/leachables studies are necessary. You perform extractables/leachables studies to write a toxicological risk assessment of the chemistry data. A risk assessment cannot be written unless the chemicals are identified. Unknown chemicals in a risk assessment treated as high risk – considered carcinogenic or genotoxic. It may not require a high concentration of an unknown to lead to an unfavorable risk assessment of patient safety. It may be as low as 1.5 µg/device.
WuXi AppTec understands the consequences of unknowns in a chemistry report. We regularly redo work from competitive labs due to unknowns in their chemistry reports. We built our chemistry laboratory to identify virtually all of the chemicals. After conducting over 3000 extractables/leachables programs, we have established a reputation within the industry for our dedication and commitment to complete chemical characterization and identification.