Strategic Approaches to Global Regulatory Success: Intended Purpose and Indications for Use

By Heather Crawford and Evangeline Loh

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?

The intended purpose and indications for use also dictate regulatory strategy

Notwithstanding the principal mode of action, these statements also position the product as a medical device and assist with the risk classification, the similarity to other devices, and the available regulatory routes. To leverage the similarity to a cleared substantially equivalent product, the devices are to have the same intended uses (21 USC §360c(i))). In the EU, when a device doesn’t possess an indication for use, it seems much more plausible for the device to capitalize on Article 61(10) of the MDR.

Considerations to draft an intended purpose and indications for use

We advance that a multidisciplinary team should be involved in compiling the intended purpose and indications for use statements.

Some elements to consider:

• Physical device description
• Mechanism of action
• Clinical condition(s) product expected to treat or diagnose
• Who are the patients
• Claims desired
• When the product cannot be used, warnings
• Attributes of the device/conditions of use
• Users of product and use environment, usability
• Predicate or equivalent (or similar) devices
• Regulatory classification system and nomenclature codes (GMDN, EMDN, JMDN…)
• Reimbursement

Concluding remarks

A well-developed intended purpose and indications for use are pivotal to the compilation of the regulatory documents (to support the compliance of a device). This contributes to the risk classification of the device as well as the identification of similar devices and available regulatory routes. In addition, it serves as the plan which helps with ensuring the appropriate evidence is provided to support the use of the device.

We will publish more about RAPS 2024. If you are interested in the update from RAPS about the MHRA (UK) regulator on the current state of the legislation, please access our regulatory update.