Introduction In 2022, the Journal of Medical Device Regulation published an article1 by this author describing the prospects for the evolution of ISO 10993-1, with particular attention to the progressive alignment with the ISO 14971 risk management system and the…
The fourth edition of ISO 7405:2025, Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, has been issued1. ISO 7405 provides a set of biological test methods to evaluate the biocompatibility of medical devices used in dentistry. These…
The Pharmaceuticals and Medical Devices Agency has compiled and published the Review Points for Biological Safety Assessment on 4 June 20251. These review points indicate the necessary evaluation items, etc. for medical devices in accordance with ISO 10993-1 or JIS…
Guidance has been drafted1,2 to set out recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices in an effort to improve the consistency and reliability of analytical chemistry studies. The guidance has been deemed necessary as the…
Final guidance has been published on the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”1. This guidance replaces the 2000 guidance of the same name and…
Final guidance for industry and Food and Drug Administration (FDA) staff entitled Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling has been released1,2 to provide information on updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance…
Introduction A medical device ‘shall be safe and effective, […] taking into account the generally acknowledged state of the art’1: in other words, safety and efficacy are essential to a medical device. Safety, according to Regulation (EU) 2017/745 on medical…
The fourth edition of ISO 10993-10:2021, Biological evaluation of medical devices – Part 10: Tests for skin sensitization, was published in November 20211. This 48-page standard specifies the procedure for the assessment of medical devices and their constituent materials regarding…
A first amendment has been drafted1,2 for ISO 10993-18:2020, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process. This proposed amendment is undergoing voting in the ballot stage until 8…
On 9 July 2021, the Food and Drug Administration updated its Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol final guidance to clarify acceptance criteria for nitinol transformation temperatures when evaluating nitinol pseudoelastic properties1. The previous version of…
Introduction According to Regulation (EU) 2017/745 on medical devices (the MDR)1, a medical device is defined as ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for…
Further clarification and updated information on the use of international standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, to support applications to the Food and Drug Administration (FDA) has…
The unique properties of nitinol have prompted the Food and Drug Administration to issue new guidance1,2 outlining the specific technical considerations for devices that have at least one patient contacting component comprised of nitinol. The guidance provides clarity and consistency…
Comments have been sought on draft amendments1 to the Rules for conducting studies (tests) for evaluation of biological action of medical products2. These draft amendments to the Rules apply to medical devices issued for circulation in the territory of the…
Introduction Nitinol is an alloy of nickel and titanium with major applications in the medical device industry due to its unique pseudoelasticity and shape memory behaviour. Nitinol has been used extensively in cardiovascular stents, heart valves, guidewires, etc, as well…
A draft guidance document entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol has been published1,2 to set out proposed recommendations for what manufacturers should include in their pre-market submissions for devices containing nitinol (an alloy of nickel…
Introduction The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’,…
