Welcome to our second post in the deficiency case series. In this post, we address an important aspect of clinical evaluation reports: the limitations of off-label use data in supporting equivalence for obese patients. In this post, we will explore why data from the equivalent device cannot fully support the subject device due to its off-label use.
Deficiency: Off-Label Use Data and Equivalence
One of the deficiencies we have encountered in the clinical evaluation reports is the reliance on off-label use data from the equivalent device to support the subject device’s claims in obese patients. The contraindication of obesity listed in the instructions for use (IFU) raises concerns about the validity of this data.
The Impact on Equivalence: Equivalence is a critical factor in MDR clinical evaluation. It ensures that the subject device performs similarly to the reference device in terms of safety and performance. However, when off-label use data is used, it introduces significant limitations and challenges.
The Limitations of Off-Label Use Data: Off-label use refers to the utilization of a medical device for an indication not approved by EU. In the current case, the data collected on obese patients was considered off-label use due to the contraindication of obesity listed in the IFU of the equivalent device. Off-label use data, by its nature, does not meet these requirements as it indicates that the device has not been adequately tested or approved for use in obese patients.
Response: In the given case, the manufacturer acknowledged that the data on the use of the equivalent device in obese patients was considered off-label use according to labeling statements. However, the response utilized the analysis of real-world evidence to support the safety and performance of the equivalent device in this patient group. Ultimately, the deficiency regarding the off-label use of the proposed equivalent device in obese patients was addressed by lifting the contraindication on obesity. The analysis of real-world usage of the equivalent device, including its use in obese patients, showed no performance or safety concerns. Therefore, while the use of the equivalent device in obese patients may have been considered off-label according to labeling statements, real-world evidence supported its safety and performance in this specific patient group.
Conclusion: The reliance on off-label use data from the equivalent device to support the subject device’s claims of equivalence in obese patients in this case highlights pitfalls of claiming equivalence. Careful consideration of the contraindications for the equivalent device is important during the planning stage.
*Disclaimer: Please note that the information provided in this blog post is based on the given context and past experience and may not apply to your specific situation as each audit and submission is unique.