December 18th 2023: Partial Recognition of ISO 10993-17 (2023) Biological Evaluation of Medical Devices-Part 17 by the FDA

ISO 10993-17 (2023) Biological Evaluation of Medical Devices-Part 17—Toxicological Risk Assessment of Medical Device Constituents, was recognized (partially) by FDA today for implementation prior to December 20, 2026. 

ISO 10993-17 describes the toxicological risk assessment process for the evaluation of constituents identified in and extractables evaluation or similar chemical characterization and defines the acceptance criteria. The extend of recognition is available at the CDRH Recognized Consensus Standards as defined in the following link:

This 2023 version of the ISO standard introduces new risk assessment concepts, like the toxicological screening limit (TSL), an important concept for toxicological risk assessors. The TSL provides an opportunity to eliminate identified compounds which are at levels too low to present a toxicological risk, based on the device duration of use.

ISO 10993-17 still includes the basic Tolerable Intake (TI) calculations and now includes details and supporting information for selection of uncertainty factors. Safe limits are left in the units of mass per body weight (e.g. µg/kg/day or mg/kg/day) and gone is the patient body weight specific Tolerable Exposure Level.  Additional things to know include the Total Quantity (TQ) and the Estimated Exposure Dose (maximum), or EED_max and the period of assumed exposure to the constituent. ISO 10993-17 describes the use of release rate kinetics information, when collected in a study, to better approximate patient exposure.

Gad Consulting Services is available to support your toxicological risk assessment needs, including implementation of version 2023 of ISO 10993-17. We’ve been in business for over 35 years, consulting in the pharmaceutical and medical device industries and would love to connect in order to assist you with your project goals.