While it was a whirlwind of less than 25 minutes for five lofty learning objectives on global regulatory strategy, we felt all the topics were seminal. A synopsis of one part of our presentation follows.
The importance of a well-defined intended purpose and indications for use
As we continue to observe issues related to the intended purpose/use and indications for use, we emphasized the importance of understanding the definition of those terms, as well as elements to consider in compiling these. And of course, it doesn’t help that in the US, there’s a legislative definition for indications for use (21 CFR 814.20(b)(3)(i)) though intended use is only in guidance (“The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” July 2014). While in the EU, intended purpose is defined in the regulations (Article 2(12) MDR), though indications for use only in guidance (MDCG 2020-6).
Would it be too bold to assert that the intended purpose and indications for use are analogous to the objective? If a manufacturer doesn’t have this for the device or IVD, how will the organization be aligned on the purpose, function and clinical use of the device?
Strategic Approaches to Global Regulatory Success: Intended Purpose and Indications for Use
Emergo by UL sponsored a session in the Exhibit Hall (Sept. 18) titled Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success during RAPS 2024. This is part of a series on RAPS.
www.emergobyul.com
