The CDS Coalition has filed a citizen petition to have the FDA withdraw its final guidance for clinical decision support (CDS) software, a development that could prove essential to unlocking the market for these products.
Augmented reality and virtual reality (AR/VR) might never dominate the world of medical technology the way cardiology devices once had, but AR/VR products are becoming more important as digital health and telehealth play an increasingly central role in 21st Century healthcare.
The field of augmented reality/virtual reality (AR/VR) is the subject of nearly 40 FDA marketing authorizations in the past few years, but this is still a relatively unexplored technological area. The FDA’s medical extended reality (MXR) program was established in 2021 to address some of the deficits in methods for validating AR/VR products.
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.
Electronic Quality Management System
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