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:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=44811

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 EEDmax 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.

FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. 

The document, issued on June 16th, can be accessed through the following link:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf

There will also be a webinar on the final guidance on July 21, 2016. It will take place from 1:00 -2:30 PM, Eastern Time. For more information use the following link:

http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm507235.htm

Dr. Gad frequently teaches courses, through the Center for Professional Advancement (CfPA), on various broad-based topics in toxicology.

Listed below are his upcoming courses, all of which are open for registration!

To take advantage of our 10% Course Director Referral Discount, when you register simply use the code CD508. We look forward to seeing you!


Non-Clinical Drug Safety Evaluation and Drug Development:

July 20-22, 2016
Burlingame, CA

Course offering: 1607-403; Course ID: 1153
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1607-403/1153


Impurities, Leachables and Extractables Qualification:

August 22-23, 2016
Chicago, IL

Course offering: 1608-403; Course ID: 2703
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1608-403/2703


Safety Assessment for Medical Devices and Combination Products:

August 24-26, 2016
Chicago, IL

Course offering: 1608-404; Course ID: 719
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1608-404/719


Impurities, Leachables and Extractables Qualification:

3-4 October 2016
Amsterdam, The Netherlands

Course offering: 1610-105; Course ID: 2703
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1610-105/2703


Non-Clinical Drug Safety Evaluation and Drug Development:

5-7 October 2016
Amsterdam, The Netherlands

Course offering: 1610-106; Course ID: 1153
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1610-106/1153


Safety Assessment for Medical Devices and Combination Products:

14-16 November 2016
Amsterdam, The Netherlands

Course offering: 1611-306; Course ID: 719
Register at: http://www.cfpa.com/CourseDescription/CourseDescription/1611-306/719