Summary

“When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples, and regulatory considerations surrounding off-label use, as well as the importance of documentation and collaboration among teams. The discussion highlights the potential benefits of off-label use for patient care while also addressing the need for risk management and monitoring to ensure safety and compliance.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:15 Introducing to Kristen Petersen

02:25 Understanding Off-Label Use: Definitions and Examples

07:33 Understanding Off-Label Use in the Context of ISO 14971

11:23 Opportunities and Challenges of Off-Label Use

13:526 Documenting Off-Label Use in Clinical Evaluation Reports

18:25 Reasons Behind Off-Label Use by Healthcare Professionals

21:59 Regulatory Considerations for Off-Label Use

23:45 Announcements, Key Takeaways and Closing Remarks

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Suggested links:

LTR: Understanding the notified body perspective on clinical evaluation.

Team NB: Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745.

ACHIEVE: Post-Market Surveillance Workshop.

Key Takeaways

* Off-label use is when a device is used outside its intended use.

* Understanding off-label use is crucial for regulatory compliance.

* Risk management plays a key role in addressing off-label use.

* Collaboration among teams is essential for effective monitoring.

* Documentation of off-label use should be integrated into clinical evaluation reports.

* Off-label use can provide opportunities for expanding indications.

* Healthcare professionals sometimes use devices in unapproved and off-label ways to solve patient issues.

* Regulatory bodies are increasingly recognizing the importance of monitoring and reporting off-label device use.

* Ambiguous labeling can lead to unintentional off-label use.

* Continuous monitoring of literature and adverse events is necessary.

Keywords

Off-label use, clinical evaluation, medical devices, risk management, regulatory compliance, healthcare professionals, patient safety, documentation, post-market surveillance, medical writing

About Kristen Petersen

Kristen Petersen is Manager – CER Specialist (Medical Devices) at Global Regulatory Writing & Consulting (GLOBAL), where she leads the development of Clinical Evaluation Reports (CERs) under EU MDR and MDD, having authored and overseen more than 50 such reports. With over eight years in the medical device industry, she helps organizations translate clinical data into regulatory-ready narratives and mentors teams on best MDR practices. She holds a Bachelor’s degree in Political Science and Government from Brigham Young University.

Since this recoding, Kristen has transitioned to a new role as a Principal Medical Writer/ Clinical Evaluation Specialist at Johnson & Johnson MedTech (Shockwave Medical).

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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