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SeqMatic Forum: Device Classification of ISO 10993-1

Assessing the safety risk associated with medical devices is fundamental to their development and approval process. The International Organization for Standardization (ISO) 10993-11 categorizes devices into different classes based on potential risk, from Class I devices like Band-Aids and toothbrushes to Class III devices such as knee implants, stents, and neural probes (see Figure 1). This classification system underscores the importance of conducting rigorous testing and evaluation, including histopathological assessments, to ensure devices are safe for their intended use. It directs the path toward safe and effective medical device innovation, ensuring that they meet the highest standards of patient safety before market release.
Figure 1: Prior to a medical device being placed on the market, the device needs to be assessed for its classification 2 3. This includes Class 1 devices which are of low risk, such as a bandaid, and may even be exempt from receiving a 510 (k) clearance. Class II devices, which are moderately risky, such as a continuous subcutaneous infusion set and will typically require a 510 (k) approval from the FDA. Class III devices, which are highly risky, such as a cardiac stent, and will more than likely require premarket approval. Lastly, for novel devices, such as a non-invasive low intensity focal ultrasound used for modulating activity in the brain that may fall under an alternative pathway for the FDA to try and structure receiving approval.

Citations:

  1. International Organization for Standardization. (Year). ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. https://www.iso.org/standard/68936.html
  2. Arena Solutions. (n.d.). How to classify your medical device for FDA approval. Arena Solutions. Retrieved [4/25/2024], from https://www.arenasolutions.com/resources/articles/how-to-classify-your-medical-device-for-fda-approval/
  3. Kirsh D. (2019). Exploring FDA approval pathways for medical devices. Mass Device. https://www.massdevice.com/exploring-fda-approval-pathways-for-medical-devices/

DISCLAIMER: Images featured in this post include assets that have been adapted for the post. Original images are credited to their corresponding cited references. Refer to citation links for publication and author’s scientific context.

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