2022 - ISO 11608: Best Practices to De-Risk & Shorten Time to Market for Wearable Injectors

As the regulatory guidance and expectations around drug device combination products continues to develop, the agreed upon approaches to demonstrate safety and effectiveness likewise develops. One long awaited significant change involves the 2022 revision of ISO 11608, Needle-based injection systems for medical use — Requirements and test methods: Parts 1-5, along with the addition of Part 6, which is specific to On-Body Delivery Systems.
This new standard is a result of collaboration between industry and global regulatory authorities via the ISO Technical Committee 84 working groups. The 2022 versions of ISO 11608 Parts 1-6 were recognized by the US Food and Drug Administration (FDA) as consensus standards for on-body injectors (Product Code QLF) on May 30, 2022. The 2022 revisions were created in part to satisfy the increase in wearable injection devices, where no existing standard directly applied.
Although the prior versions of the ISO 11608 series of standards (Parts 1-5) have been in place, the expectation from the FDA is that compliance to the 2022 revisions should occur prior to July 9, 2023, and compliance with Part 6 is in effect as of May 30, 2022. Therefore, medicinal product manufacturers should work with their device counterparts on a plan for implementation to ensure timely global regulatory compliance. Understanding the impact of these new revisions on development timelines is vital as wearable injectors become more desirable by patients.
The featured speakers will cover highlights of the major updates, including the impact to both device and pharmaceutical manufacturers, and how holistic implementation strategies can decrease risk and shorten time to market. In addition, the speakers will showcase interactive best practices examples that provide real-world methods for aligning drug and device development pathways for a combination product-centric approach.
Register to learn how the new revisions and additions to the 2022 ISO 11608 series impacts the wearable injectors market.