CDRH publishes dataset to help improve chemical characterization methods
The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has published a dataset intended to help analytical laboratories demonstrate their ability to detect a broad range of chemicals that may be encountered in a non-targeted analysis as part of a comprehensive extractables/leachables program. The dataset contains a list of over 100 chemicals that have been characterized in CDRH laboratories by means of gas chromatography (GC). Besides relative retention factors (RRF) and various physicochemical parameters, the
Update of ISO standard for toxicological risk assessment of medical device constituents
Toxicological Risk Assessment; International standard. The International standards organization (ISO) has updated its ISO 10993-17 standard, that describes the process and requirements for the toxicological risk assessment of medical device constituents. After more than 20 years, the standard replaces the previous version from 2002, introducing various changes. The new revision is more extensive than the previous edition as it clarifies when a toxicological risk assessment is recommended, how to calculate the worst-case estimated exposure dose of a constituent and when the probability of occurrence
Regulatory framework: Release of FDA Guidance for Use of International Standard ISO 10993-1
FDA has updated their guidance document on ISO 10993-1 to assist industry in preparing regulatory submissions. It incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, and biocompatibility recommendations when certain materials only contact intact skin. Link